ArticlePDF Available

Efficacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause

Authors:
  • Clínica Sexológica

Abstract and Figures

Objective: To evaluate the efficacy and tolerance of policresulen in the treatment of genitourinary syndrome of menopause Materials and methods: Controlled clinical trial, randomized, masked “double-blind”. 321 women aged 40 or older, diagnosed with genitourinary syndrome of menopause, who had engaged in sexual activity in the last six weeks, and had visited a Level III private health care institution in Armenia, Quindío (Colombia), from February to December 2018 were included. Women under hormonal treatment and with absolute contraindications for the use of policresulen were excluded. Women were randomly assigned to two treatments: 117 received policresulen and 114 placebos (control group). Efficacy and tolerance were evaluated, as well as the adverse effects presented during the 12 weeks of follow-up. A non-strict consecutive sampling was made. Results: The dose of policresulen was effective for symptom control, showing an efficacy of 76.92%, (n=90/117), versus 38.59%, (n=44/117) in the placebo group, with a statistically significant difference (p=0.003). Policresulen tolerance was adequate in 91.45% of women, compared to 92.98% of placebos, without statistically significant difference (p=0.375). The incidence of adverse effects was as follows: local burning sensation (4.27%), discharge of mucosal tissue fragments (2.56%) and vaginal candidiasis (1.7%) in the policresulen group, compared with, 5%, 1.75% and 1.75%, respectively, in the placebo group. There were fewer adverse effects in the placebo group, but there was no statistically significant difference between groups (89.74% vs. 92,1; p=0,27). Conclusion: The use of policresulen in women with genitourinary syndrome of menopause is effective for the management of the most frequent symptomatology. Although it is true that it is not the first therapeutic line of treatment, it should be considered in women for whom estrogen therapy is contraindicated or in those who do not wish to receive it. There was a low presence of adverse effects at the dose used, however, these were tolerable and did not require the interruption of the medication. Keywords: dyspareunia, menopause, atrophy, lubrication, Efficacy, drug tolerance
Submit Manuscript | http://medcraveonline.com
Introduction
For the last ve years, new terminology has been introduced to
describe atrophic vaginitis, atrophic Volvo-vaginitis or postmenopausal
vulvo-vaginal atrophy; thus the new term genitourinary syndrome
of menopause (GSM), which is dened as “a set of symptoms and
signs associated with a decrease in estrogen and other sex steroids
that involve changes in the labia majora or minora, clitoris, vestibule/
introitus, vagina, urethra and bladder.” The modication was required
because the rst terms did not include most of the constellation of
signs and symptoms present during this specic moment in women´s
life, especially because they do not consider the symptoms associated
to the lower urinary tract. In addition, it has been seen that not
everyone is comfortable talking about the vulva and/or the vagina
(health professionals or patients), which is why the term atrophy has
an inadequate connotation.1,2 The prevalence of GSM in Colombia
is around 51.61%.2 It causes vaginal dryness, dyspareunia, vaginal
irritation, genital pruritus (burning sensation), sinusorrhagia and
urinary symptoms (most uncomfortable for women).1–3 71.87% of
symptomatic women have three vulvo-vaginal symptoms and/or
urinary tract symptoms;2 but only 64% complain of painful sexual
intercourse and loss of libido, which is why 58% avoid sexual
intercourse,4 especially coitus. The WHO estimates 1,200 million
women will be over 50 years of age by 2030.5 Consequently, if GMS
causes negative vaginal problems, as well as frequent emotional and
sexual disorders, leading to adverse effects on the quality of life of
postmenopausal women,2,6,7 it is critical that health professionals
understand menopause, and know how to prevent its catastrophic
effects.
The treatment and management of GMS should be individualized
for each woman, considering the severity of the symptoms, the effect
on the quality of life, the risk of recurrence and personal preferences.
The options highlight both hormonal and non-hormonal therapies,
with estrogen therapy being the rst therapeutic line for symptom
relief.8,9 The information that is available regarding the use of non-
hormonal therapies is endless, and the results vary. Policresulen
is a solution indicated for the topical treatment of inammations
or of cervico-vaginal tissue lesions. It coagulates the necrotic or
pathogenically altered tissue and promotes the scaliness of said
tissues. It is a polymolecular organic acid; a condensation polymer of
metacresol sulfonic acid bonded to methylene bridges with different
Int J Fam Commun Med. 2019;3(3):132136. 132
© 2019 De La Hoz. This is an open access article distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and build upon your work non-commercially.
Efcacy and tolerance of policresulen in the
treatment of the genitourinary syndrome of
menopause
Volume 3 Issue 3 - 2019
Franklin José Espitia De La Hoz
Ginecología y Obstetricia, Universidad Militar Nueva Granada,
Colombia
Correspondence: Franklin José Espitia De La Hoz, Ginecología
y Obstetricia, Universidad Militar Nueva Granada, Sexología
Clínica, Máster en Sexología, Educación y asesoramiento
sexual, Universidad de Alcalá de Henares, Uroginecología/
FUCS - Hospital de San José/Unicamp, Brasil, Clínica Sexológica,
Armenia, Quindío, Colombia, Email
Received: June 14, 2019 | Published: June 26, 2019
Abstract
Objective: To evaluate the efcacy and tolerance of policresulen in the treatment of
genitourinary syndrome of menopause
Materials and methods: Controlled clinical trial, randomized, masked “double-blind”.
321 women aged 40 or older, diagnosed with genitourinary syndrome of menopause, who
had engaged in sexual activity in the last six weeks, and had visited a Level III private
health care institution in Armenia, Quindío (Colombia), from February to December 2018
were included. Women under hormonal treatment and with absolute contraindications for
the use of policresulen were excluded. Women were randomly assigned to two treatments:
117 received policresulen and 114 placebos (control group). Efcacy and tolerance were
evaluated, as well as the adverse effects presented during the 12 weeks of follow-up. A non-
strict consecutive sampling was made.
Results: The dose of policresulen was effective for symptom control, showing an efcacy
of 76.92%, (n=90/117), versus 38.59%, (n=44/117) in the placebo group, with a statistically
signicant difference (p=0.003). Policresulen tolerance was adequate in 91.45% of women,
compared to 92.98% of placebos, without statistically signicant difference (p=0.375). The
incidence of adverse effects was as follows: local burning sensation (4.27%), discharge
of mucosal tissue fragments (2.56%) and vaginal candidiasis (1.7%) in the policresulen
group, compared with, 5%, 1.75% and 1.75%, respectively, in the placebo group. There
were fewer adverse effects in the placebo group, but there was no statistically signicant
difference between groups (89.74% vs. 92,1; p=0,27).
Conclusion: The use of policresulen in women with genitourinary syndrome of menopause
is effective for the management of the most frequent symptomatology. Although it is true
that it is not the rst therapeutic line of treatment, it should be considered in women for
whom estrogen therapy is contraindicated or in those who do not wish to receive it. There
was a low presence of adverse effects at the dose used, however, these were tolerable and
did not require the interruption of the medication.
Keywords: dyspareunia, menopause, atrophy, lubrication, Efcacy, drug tolerance
International Journal of Family & Community Medicine
Research Article Open Access
Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause 133
Copyright:
©2019 De La Hoz
Citation: De La Hoz FJE. Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause. Int J Fam Commun Med.
2019;3(3):132136. DOI: 10.15406/ijfcm.2019.03.00145
chain lengths, making it a large molecule, that cannot be absorbed
into the systemic circulation; it as a localized effect in the affected
tissue where it is applied, and does not affect healthy tissues. It
stimulates the regeneration and reepithelization processes, and has
astringent properties, granting it healing, anti-inammatory and anti-
hemorrhagic properties. In addition, due to its high acidity (pH<0.6)
it as a high bactericidal and self-sterilizing power, eliminating the
possibility of bacterial multiplication.10,11 This study seeks to learn
about the effectiveness and tolerability of policresulen; its objective
is to evaluate the efcacy and tolerance of policresulen in the
treatment of genitourinary syndrome of menopause (GSM), as a non-
hormonal alternative, in a sample of postmenopausal women from the
Department of Quindío, Colombia.
Materials and methods
Design and population Controlled, randomized, masked “double-
blind” clinical trial, conducted from February 1, 2018 to December
31, 2018 in Armenia, capital of the department of Quindío (located in
the central region of Colombia). The study was carried out at Clinica
Sexológica, a private healthcare reference center, an academic center,
that takes care of people pertaining to private and social security health
care plans, in Colombia. Sample size: considering a condence level
of 95%, with an error margin of 3% and an expected proportion of 5%,
the estimated calculated sample was of 203 women. Patient selection
was done through a simple random sample, with a table of random
numbers. The sampling was consecutive non-strict. Women older
than or equal to 40 years, diagnosed with genitourinary syndrome of
menopause, who had engaged in sexual activity in the last six weeks
were included. Women under hormonal treatment and with absolute
contraindications for the use of policresulen were excluded.
Procedure
Women were selected from the population of patients assigned
to the menopause and climacteric program of the institution. The
information was collected by nurses from the research team, duly
trained in the process of recruiting patients and completing forms.
Women were surveryed during their medical appointment with the
specialist, after verifying inclusion and exclusion criteria. If women
fullled the selection criteria and accepted to participate in the
study, they were informed about the objectives of the research and
were asked to ll out the informed consent and the condentiality
agreement for information management. Once women signed the
informed consent, they were given a self-report questionnaire where
socio-demographic characteristics, sexual and reproductive health
data, symptoms, background and clinical examination data were
recorded. The specialist evaluated the presence of GMS according
to the symptomatology reported by the woman. The diagnosis was
made with the nding of one or more of the following symptoms:
vulvo-vaginal symptoms (burning, decreased vaginal lubrication,
dyspareunia, pain, coital discomfort, itching, burning, postcoital
bleeding and vaginal dryness) or lower urinary tract symptoms
(dysuria, bladder tenesmus, nocturia, frequency, recurrent urinary
tract infections, urinary urgency, urinary incontinence, postcoital
infection and decreased urethral urine ow).1,2 Once the diagnosis
was made, the nature of their clinical condition was explained to each
woman, and therapeutic alternatives were offered (local policresulene
or the use of placebo). The placebo was characterized as a pure and
inactive substance, a water-based type of lubricant.
Intervention
All patients were prescribed treatment. They were randomized
to receive one of the two preparations (policresulen or placebo).
The medications were presented in identical containers; neither the
women nor the researcher knew which solution each woman received.
Each patient was given administration instructions and the quantity
required until the following appointment. The therapy assignment was
made based on a table of random numbers, in blocks of 6 subjects.
Evaluation
For eleven months, 231 women with a diagnosis of menopausal
genitourinary syndrome were recruited. All the patients included in the
research were evaluated during a twelve-week treatment period, with
four evaluation controls. They were followed up every four weeks
until completing the follow-up cycle. In each appointment they lled
in a questionnaire on efcacy, tolerance and adverse events potentially
related to the substance that had been administered. Likewise, they
were provided with the medication required for continuation of
the treatment. Patients were prescribed a full dosage of 5 grams of
policresulen. They were prescribed a daily vaginal gel application
for 4 weeks, at bedtime; and an application twice a week (three days
interval) as a maintenance therapy, until completing the 12 weeks. In
each follow-up visit, adherence to treatment was monitored, and the
patients had to rate the effectiveness by a percentage evaluation of the
main signs and symptoms of GMS [urinary symptoms, sinusorrhagia,
genital pruritus (burning sensation), irritation vaginal, dyspareunia
and vaginal dryness]] according to prevalence in recent Colombian
publications,2,3 and of their own symptoms upon admission.
Symptoms were classied according to severity as follows: Severe
(greater than 75%), Moderate (greater than 25% and less than 75%) and
Mild (less than 25%). The evaluation of the effectiveness was made
by means of rating the percentage of decrease of the symptoms, using
a subjective evaluation table designed for the purpose and that offered
the following reports: Excellent (decrease greater than 75%), Good
(decrease greater than 50% and less than 75%), Moderate (decrease
greater than 25% and less than 50%) and Poor (decrease less than
25%). The efcacy was established by the difference in improvement
for the values associated to a decrease in symptomatology in both
groups at the end of the treatment. Tolerance was evaluated in each
follow up visit by looking for the absence or presence of symptoms
or signs associate to adverse reactions; it was classied as Excellent
(there were no adverse effects), Good (one adverse effect), Regular
(two adverse effects) or Bad (three or more adverse effects). These
data were evaluated by the researcher, through direct questioning; the
responses of each follow up visit, as well as the adverse effects, were
recorded in the clinical history and in a special format designed by
the researchers.
Measured variables
Socio-demographic variables such as (age, race, marital status,
occupation, level of studies, height, weight, body mass index (BMI),
alcohol intake, smoking, sedentary lifestyle); age of menarche and
menopause, evolution of time of menopause, history of hysterectomy,
salpingectomy and gynecological or urological surgery; variables
of sexual and reproductive health: age of onset of sexual life,
masturbation, oral sex, vaginal or anal intercourse, average frequency
of monthly sexual relations, time of cohabitation with a partner, history
of sexual abuse or sexual violence in marriage and a couple with
Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause 134
Copyright:
©2019 De La Hoz
Citation: De La Hoz FJE. Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause. Int J Fam Commun Med.
2019;3(3):132136. DOI: 10.15406/ijfcm.2019.03.00145
sexual dysfunction were considered. The percentage of evaluation of
the efcacy and tolerance of the substances administered, the presence
of adverse effects, as well as the time of symptom improvement were
also evaluated.
Statistical analysis
The collected data were analyzed statistically using the Six Sigma
statistical program. The applied tests were the “t” of Student for
comparison of socio-demographic parameters, the Wilcoxon test for
the comparison of non-parametric paired data, the Mann-Whitney U
for the nonparametric data (unpaired), the test for χ2 and the ANOVA
(analysis of variance), taking in all cases the p value <0.05 as the limit
of statistical signicance.
Ethical aspects
The study was approved by the Ethics and Research Commission
of Clinica Sexólogica. The signature of the informed consent was
requested for participation in the study, and the condentiality of the
information was guaranteed.
Results
Of a total of 279 women, with symptomatology associated to the
genitourinary syndrome of menopause, 258 women were included
(92.47%) and seven (2.71%) refused to participate. Of the remaining
251 women who met the selection criteria, a total of 11 (4.38%) did
not provide all the required information, another 5 (1.99%) withdrew
before completing the 12-week follow-up and were rejected 4
(1.59%) due to poor treatment compliance. In this way, a total of 231
(92.03%) women were considered for the nal analysis; 117 received
policresulen and 114 received placebo. In the total population, the
mean age of the participants was 56.72±8.35 years (range between
40 and 84), and that of the couple was 59.86±7.42 years (range
between 42 and 93). They were mostly Hispanic, Catholic, employed,
middle class, stable union, high level of schooling, urban origin
belonging to private health care plans. The age of onset of menopause
was 49.31±8.37) years (range between 42 and 54), with a mean
menopause duration of 7.94±5.27 years (range between 3 and 12).
The socio-demographic characteristics were similar in both groups,
with no statistically signicant differences (Table 1). The mean age of
menarche was 12.58±0.79 years (range between 9 and 15 years). The
reported age for rst sexual intercourse was on average 18.62±4.18
years (range between 15 and 24) The age of the rst delivery was a
mean of 19.35±5.27 years (range between 15 and 27), with a median
of 3 children (range between 0 and 7). 29.43% (n=68/231) reported
more than 20 years living with a couple.
A total of 78.35% (n=181/231) of the participants stated they had
active sexual lives and 10.38% (n=24/231) used sex toys, 68.83%
expressed they felt pain during intercourse, 77.48% afrmed there had
been a loss of libido, while 59.74% expressed that they avoided sexual
intercourse using all kinds of excuses. Masturbation is considered a
common practice in 44.58% (n=103/231) of the participants. A total
of 98.26% manifested that sexual activity was important in their life;
41.12% afrmed that sex was fundamental in their life, yearning
for a coital frequency of 1 to 4 times per week (median 2 times a
week); however, 35.82% were concerned that their children were
aware they were sexually active. 93.07% considered sexual activity
as essential for marriage success. To the question, ¿how many times
did you have sex last month? (period dened as the period of the
previous thirty days), 41.12% (n=95/231) reported a median of 4
sexual intercourses per month (range between 0 and 9). The most
frequent sexual practice was vaginal intercourse (100%), and the least
frequent was anal intercourse (11.68%). 94.37% (n=218/231) of the
women stated that their partner had some sexual dysfunction. 17.74%
(n=41/231) reported having suffered some form of sexual violence
throughout their lives, while 22.51% (n=52/231) reported violence or
sexual abuse by the couple, after the onset of menopause, secondary
to the refusal to voluntarily consent to sexual activity. The prevalence
of the severity of the symptoms of GMS in the policresulen group
was Severe in 70.94% (n=83/117), 17.09%, (n=20/117) Moderate
and 11.96%, (n=14/117) Mild. In the placebo group it was Severe
in 69.29% (n=79/114), 16.66%, (n=19/117) moderate and 14.03%,
(n=16/114), mild with one p> 0.05, without statistically signicant
difference.
Table 1 Sociodemographic characteristics of women from Armenia, Quindío
with genitourinary syndrome of menopause
Policresulene
(n=117)
Placebo
(n=114) p
Age (years), mean±SD 56, 72; p=8, 35). 57, 32; p=7, 49). 0.43
Height (cms) 158; p=0, 76). 160; p=0, 85). 0.71
Weight (kg) 78.61; p=1, 8). 80.35; p=1, 5). 0.68
BMI 31.2; p=0, 59). 31, 3; p=0, 74). 0.93
Race
Hispanics% 56.41 50.87 0.57
Afrocolombians% 25.64 33.33 0.12
Indigenous% 17.94 15.78 0.45
Educational Level
Primary% 11.96 29.64 0.36
Secondary% 19.65 21.92 0.15
Technical% 43.58 40.35 0.18
Tertiary% 24.78 28.07 0.39
Civil Status
Divorced% 15.38 12.28 0.81
In union 41.88 43.85 0.75
Married% 35.04 37.71 0.61
Widowed% 7.69 6.14 0.83
Origin
Rural% 20.51 17.54 0.13
Urban% 79.48 82.45 0.26
Occupation
Housewife% 32.47 35.96 0.53
Employed% 52.99 56.14 0.47
Retired% 14.52 7.89 0.23
Addictions%
Smoking 23.07 27.19 0.41
Alcohol% 78.63 79.82 0.29
Sedentarism% 76.06 68.42 0.14
Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause 135
Copyright:
©2019 De La Hoz
Citation: De La Hoz FJE. Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause. Int J Fam Commun Med.
2019;3(3):132136. DOI: 10.15406/ijfcm.2019.03.00145
Related to the symptoms that affected the patients, the most frequent
symptom was vaginal dryness, followed by dyspareunia and vaginal
irritation in both groups (Figure 1). Regarding the relationship with the
vulvo-vaginal symptoms and lower urinary tract ndings associated
to GMS, it was observed that 71.87% of the symptomatic women of
the polcresulen group had 3, 22.91% had 4, and 5.2% presented 5 or
more symptoms, while in the placebo group it was observed 70.17%,
20.17% and 9.64%, respectively, without statistically signicant
difference (p>0.05). The mean length of the presence of symptoms, at
the time of treatment, was 12.65±4.79 months (range between 3 and
60). In total, 29.91%, (n=35/117) of the women of the policresulen
group and the 32.45%, (n=37/114) of those in the placebo group,
had received some type of hormonal treatment at some time life after
menopause. The evolution of the improvement and effectiveness of
the therapy, in relation to the baseline situation, in each follow-up
and at the end of the treatment is described in Table 2. At the end
of the study it was observed, that efcacy in the policresulen group
was 76.92%, (n=90/117), while in the placebo group it was 38.59%,
(n=44/117), with a statistically signicant difference (p=0.003). There
were signicant differences between the two groups regarding the
time for symptom reduction, being lower in the policresulen group
(median of 4 weeks vs 8 weeks), (p<0.05). In the policresulen group
tolerance was labeled as Excellent in 89.74% (n=105/117) and Good
in 1.7% (n=2/117), Regular in 2.56% (n=3/117) and Bad at 5.98%
(n=7/117), which implies a satisfactory tolerance in 91.45% of the
women, compared to 92.98% of the placebo, without statistically
signicant difference (p=0.375). At the end of the study, the incidence
of adverse effects was 10.25% (n=12/117) in the policresulen group,
compared to 7.89% (n=9/114) in the placebo group; the local burning
sensation being the most frequent (4.27%), followed by the discharge
of fragments of mucosal tissue (2.56%) (Table 3). In the placebo group
there were fewer adverse effects, with no differences in both groups
(89.74% vs. 92,1; p=0,27). In no case was there a need to interrupt the
treatment before end of the research study.
Figure 1 Symptoms of GSM reported in women from Armenia, Quindío.
Table 2 Percentage of the evolution of the improvement and effectiveness
of the therapy
Policresulene
(n=117)
Placebo
(n=114) p
Baseline 0 0 0
4 weeks 25.64% 13.15% 0.024
8 weeks 63.24% 29.82% 0.018
12 weeks 76.92% 38.59% 0.003
Table 3 Adverse effects
Policresulene
(n=117)
Placebo
(n=114) p
Vaginal dryness 0,85% (n=1) 0 0.11
Localized burning
sensation 4,27% (n=5) 3,5% (n=4) 0.54
Discharge of mucus tissue
fragments 2,56% (n=3) 1,75% (n=2) 0.75
Vaginal candidiasis 1,7% (n=2) 1,75% (n=2) 0.84
Erythema with papule 0,85% (n=1) 0,87; p=1). 0.93
Discussion
The results of this investigation show an efcacy of 76.92% in
the policresulen group (n=90/117), while the placebo group reported
38.59% (n=44/117), a statistically signicant difference (p=0.003).
Tolerance was labeled as Excellent in 89.74% (n=105/117) and Good
in 1.7%, which reported a satisfactory tolerance in 91.45% of the
women who received policresulen, compared to 92.98% of placebo,
without statistically signicant difference (p=0.375). At the end of
the study, the incidence of adverse effects was 10.25% (n=12/117) in
the policresulen group, compared to 7.89% (n=9/114) of the placebo
group; being the local burning sensation the most frequent one (4.27%
vs. 3.5%), followed by the discharge of mucosal tissue fragments
(2.56% vs. 1.75%), without statistically signicant differences
between groups (89.74% vs. 92,1; p=0,27). In no case was there a
need to interrupt the treatment before the end of the research study.
Signicant differences were found between the two groups regarding
the time for symptom reduction, being lower in the policresulen group
(median of 4 weeks vs 8 weeks), (p<0.05). Policresulen as a selective
effect on dead or pathologically altered tissues in the vagina, making
them coagulate with a subsequent elimination, without affecting
the healthy squamous epithelium. Its broad antimicrobial spectrum
eradicates the pathogens of the vagina (bacteria, trichomonas and
fungi), but increases the growth of Lactobacilli (Bacillus Döderlein)
responsible for maintaining the physiological acidity of the vagina. It
is useful to quickly diminish subjective complaints such as pruritus
and leucorrhea. Reepithelialization is favored both by reactive
hyperemia in the treated area and by the stimulation of the granulation
of healthy tissues.12
The characteristics of the efcacy of policresulen make it an
adequate alternative, in the treatment of the genitourinary syndrome
of menopause, for of women who have contraindications for estrogen
therapy have no interest in receiving said therapy, with higher rates of
satisfaction than ¾ parts of the participating population. In this study,
the feasibility and safety of the use of policresulen in postmenopausal
women was demonstrated, with minimum adverse effects, that did
not require any type of intervention or affected the continuation of
therapy, making it attractive, safe and easy to use. In a study conducted
in our country, Espitia et al.13 obtained an efcacy of 66.6% in the
improvement of the symptoms of GMS using a lubricant with similar
characteristics to our placebo, which is still lower than the 76,92%
reported by policresulen in this study, however it is a population with
similar socio-demographic characteristics, but with a smaller sample
size, which may indicate differences in the results obtained by these
researchers. The results of this study are comparable to the reports of
a recent investigation by Espitia et al.14 where it concludes that the
estriol used in combination with a lubricant, are effective to control
the symptoms of GMS in 87% of women, making makes policresulen
an attractive substance to consider as a choice in those women without
interest for hormonal therapy.
Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause 136
Copyright:
©2019 De La Hoz
Citation: De La Hoz FJE. Efcacy and tolerance of policresulen in the treatment of the genitourinary syndrome of menopause. Int J Fam Commun Med.
2019;3(3):132136. DOI: 10.15406/ijfcm.2019.03.00145
The characteristics of the non-hormonal therapies used in this study;
one a condensation polymer of metacresolsulfonic acid (policresulen)
and the other a water-based lubricant, suggest the possibility of a
new alternative within the therapeutic arsenal for the treatment of the
genitourinary syndrome of menopause; with higher satisfaction rates,
placebo, in syndromic management. The main strength of the study
is that it is the rst research of its kind in Colombia, in addition to
be the rst one to evaluate the use of policresulen in the treatment
of menopausal genitourinary syndrome, and to have had a sequential
sampling with a signicant participation of patients. The greatest
weakness is that the results could not be compared with other studies
of similar characteristics, since there is no scientic literature in this
regard, in addition to an approximation of the costs incurred in each
participant, which could be a limiting factor for its application in the
general community.
Conclusion
The use of policresulen in women with genitourinary syndrome
of menopause is effective for the management of the most
frequent symptomatology. Although it is true that it is not the rst
therapeutic line of treatment, it should be considered for women with
contraindications for estrogen therapy or for those who do not wish to
receive it. There was a low presence of adverse effects at the dose used,
however, these were tolerable and did not require the interruption of
the medication. Additional studies, in larger populations, are required
to establish the benet in women with estrogen-dependent cancer or
without interest in receiving estrogen therapy, as well as the costs that
this represents.
Financing
The research was nanced with the author’s own resources.
Acknowledgments
To all participating women for allowing consent and for being
part of the study; to my beautiful and admirable wife, Dr. Lilian
Orozco Santiago, for always supporting and following my crazy
investigations.
Conicts of interest
The author declares there is no conict of interest.
References
1. Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus
Conference Panel. Genitourinary syndrome of menopause: New
terminology for vulvo-vaginal atrophy from the International Society for
the Study of Women’s Sexual Health and the North American Menopause
Society. Menopause. 2014;21(10):1063–1068.
2. Espitia-De La Hoz FJ. Prevalence of genitourinary syndrome of
menopause and impact on sexuality of women in Quindío (Colombia),
2013-2016. Rev Colomb Obstet Ginecol. 2018;69(4):249–259.
3. Espitia-De La Hoz FJ, Orozco-Gallego H. Estriol vs estrógenos
conjugados de origen equino en el tratamiento del síndrome genitourinario
de la menopausia. Ginecol Obstet Mex. 2018;86:117-126.
4. Simon JA, Nappi RE, Kingsberg SA, et al. Clarifying Vaginal Atrophy’s
Impact on Sex and Relationships (CLOSER) survey: emotional and
physical impact of vaginal discomfort on North American postmenopausal
women and their partners. Menopause. 2014;21(2):137-142.
5. Panay N. Genitourinary syndrome of the menopause--dawn of a new era?
Climacteric. 2015;18(Suppl 1):13–17.
6. Moral E, Delgado JL, Carmona F, et al. Genitourinary syndrome of
menopause: Prevalence and quality of life in Spanish postmenopausal
women. The GENISSE study. Climacteric. 2018;21(2):167–173.
7. Karakoç H, Uçtu AK, Özerdoğan N. Genitourinary syndrome of
menopause: effects on related factors, quality of life, and self-care power.
Prz Menopause Rev. 2019;18(1):15–22.
8. Faubion SS, Sood R, Kapoor E. Genitourinary Syndrome of
Menopause: Management Strategies for the Clinician. Mayo Clin Proc.
2017;92(12):1842–1849.
9. Espitia-De La Hoz FJ, Orozco Gallego H. Abordaje diagnóstico y
terapéutico del síndrome genitourinario en la menopausia; actualización.
Rev Med UCR. 2017;117:67–84.
10. Scorticati CH, Levati HA, Cartelli E. Utilizacion del ácido metacresol-
sulfonico, en cirugía prostática. Rev Arg Urol Nefrol. 1973;42(1):84–85.
11. Espinosa DJ. Analytical review of multicenter studies with polycresulene
for hemorrhoidal pathologies. Acta Gastroenterol Latinoam.
2000;30(3):177–186.
12. Patetico AQ, Reyes LD, Rey-Matias CJ. Comparison of the operative
and post-operative outcome between episiorrhaphy with and without
application of policresulen solution. Philippine Obstetrical and
Gynecological Society (POGS). 2016;40(2):12–19.
13. Espitia-De La Hoz FJ, Orozco Gallego H, Echeverri Ocampo LM.
Terapia hormonal y no hormonal en la vaginitis atróca posmenopáusica:
cura y satisfacción a mediano y a largo plazo de los síntomas. Rev Col
Men. 2016;22:8–17.
14. Espitia-De La Hoz FJ, Orozco Gallego H. Evaluación de la ecacia
de dos terapias estrogénicas locales más un lubricante vaginal, para el
control de los síntomas del síndrome genitourinario de la menopausia.
Rev Investigaciones Andina. 2019;21:167–183.
... Policresulen (50% w/w solution; Albothyl, Celltrion Pharm Inc., Cheongju, Korea) is a frequently used over-the-counter topical medication used to treat stomatitis. This agent selectively coagulates pathologically altered tissues, promoting their regeneration and reepithelialization [4,5]. However, it carries a possible risk of oral mucosal injury due to its high acidity and should be used with caution [6]. ...
... Policresulen is a polymolecular organic acid that is produced by the condensation reaction between metacresol sulfonic acid and formaldehyde [4,6]. Policresulen is a commonly used topical antiseptic, which topped the Korean stomatitis drugs market with a 28.7% share in 2020. ...
... Although policresulen is indicated for the treatment of stomatitis and bacterial vaginosis, it is contraindicated in patients with hypersensitivity to any of the drug components. Policresulen causes selective coagulation of damaged tissues, while leaving normal tissues unharmed, allowing rapid reepithelialization [4,5]. This drug also has antimicrobial, astringent, and anti-inflammatory properties [4]. ...
Article
Full-text available
Oral mucosal burns can occur after contact with various chemical agents, and commonly manifest as areas of mucosal sloughing and ulceration. Policresulen (Albothyl, Celltrion Pharm Inc.) is an over-the-counter topical antiseptic that is frequently used to treat stomatitis. Policresulen solution is highly acidic, with an approximate pH of 0.6; it can thus cause mucosal injury when improperly applied in the oral cavity. Here, we present a rare case of an oral mucosal burn resulting from incorrect self-administration of policresulen and emphasize the importance of increasing understanding of this adverse drug event among consumers and health professionals.
... Por su parte, la vaginitis mixta o combinada es la co-existencia de bacteria y bacteria, hongo y parásito, hongo y bacteria, o de hongo, bacteria y/o parásito [23]. Por lo tanto, ante la constelación de síntomas del "síndrome de flujo vaginal", producto de la miscelánea de gérmenes presentes en la vaginitis mixta, el tratamiento con la combinación de fluconazol -secnidazol, es una viable opción, a pesar de que no existan estudios suficientes que evalúen dicha combinación [24], cuya efectividad se puede ver incrementada con la aplicación local del policresuleno, un antiséptico microbicida que estimula el crecimiento de los bacilos de Döderlein, restituyendo la barrera fisiológica de defensa vaginal, y evitando la proliferación de monilias, bacterias o tricomonas [25,26]. ...
... El uso de agentes tópicos, en el tratamiento de los trastornos vaginales, ha reportado una baja tasa de eventos adversos [28], lo cual es concordante con los hallazgos reportados en las pacientes que recibieron policresuleno, demostrando su significativo perfil de seguridad. Similar a lo informado por Espitia et al. [25,26] en dos estudios, realizados en el Eje Cafetero (Colombia), donde informó que el policresuleno tiene un demostrando perfil de seguridad al usarse vía vaginal, a pesar de que fuera utilizado en mujeres en la postmenopausia. ...
... El policresuleno tiene, entre otras propiedades (gracias a su elevada acidez), un alto poder bactericida y de auto-esterilización, por lo que la multiplicación bacteriana resulta imposible [25,26], lo cual lo hace una adecuada alternativa, a la hora de adicionarlo a la combinación de fluconazol -secnidazol, en el tratamiento empírico de la vaginitis mixta. ...
Article
Full-text available
Objetivo: evaluar la eficacia y seguridad de la adición de policresuleno a la terapia oral fluconazol – secnidazol, en mujeres con vaginitis mixta. Materiales y métodos: ensayo clínico aleatorizado, triple ciego, paralelo, controlado con placebo. Realizado en una clínica universitaria de Armenia (Colombia) entre 2017 y 2019. Participaron 122 mujeres mayores de 18 años, diagnosticadas de vaginitis mixta. El diagnóstico microbiológico se hizo mediante tinción de Gram, con posterior lectura del puntaje de Nugent y coloración de May Grunwald Giemsa prolongado, microscopía con KOH y frotis directo en fresco; se midió el pH con papel tornasol. Se les suministró terapia combinada de fluconazol-secnidazol oral más policresuleno vaginal (grupo «A», n=62) versus fluconazol-secnidazol oral más placebo vaginal (grupo «B», n=60). Se evaluó la mejoría de los síntomas, la tasa de curación y el porcentaje de satisfacción con la terapia. Resultados: la edad promedio fue de 29,75 ± 4,61 años. La mejoría de la sintomatología, al tercer día, fue mayor en el grupo «A» (85,48 % vs 68,33 %, p=0,001). Al final la tasa de curación (eficacia) fue superior en el grupo «A» (98,38 % vs 86,66 %) (p = 0,001). La satisfacción con el tratamiento administrado, alcanzó el 96,77 % (grupo «A») versus 93,33 % (grupo «B»), (p = 0,411). El 27,41 % de las mujeres del grupo «A» y el 13,33 % del grupo «B» presentaron dos o más efectos secundarios (p = 0,001). Conclusiones: la combinación fluconazol - secnidazol oral más policresuleno vaginal, reporta una eficacia del 98,38 % para curar la vaginitis mixta, con satisfacción del 96,77 %.
... Se le ha evidenciado propiedades astringentes, lo que suprime la exudación. Como alternativa no hormonal, en el tratamiento del SGUM, se ha probado su eficacia (76,92%), seguridad, y tolerancia del 91,45% [10]. ...
... En el tratamiento del SGUM, la terapia hormonal está indicada cuando éste se asocia a síntomas vasomotores que afectan la calidad de vida de la mujer [19,20]; pero en los casos persistentes de la sintomatología vaginal local, se puede recurrir a una alternativa adicional como lo es el policresuleno [10]. ...
... Observando los potenciales beneficios del policresuleno más allá de su incuestionable efecto hemostático local [10], de acuerdo con la experiencia clínica multidisciplinaria expresada por Espinosa et al. [21], el que además lo indica como estimulante de la regeneración y re-epitelización tisular con propiedades antimicrobianas y útil en la prevención de la inflamación, así como astringente; sorprende la nula o escasa presencia de investigaciones de su aplicación en una patología tan común en la mujer mayor, como lo es el síndrome asociado al hipoestrogenismo, que en Colombia alcanza cifras alarmantes (51,61%), con 67,2% de asociación a disfunción sexual, según lo publicado por Espitia et al. [3]. ...
Article
Full-text available
Objetivo: comparar la efectividad y seguridad del policresuleno frente al estriol y lubricante, en el tratamiento del síndrome genitourinario de la menopausia en mujeres de Armenia (Quindío, Colombia). Materiales y métodos: en mujeres diagnosticadas con síndrome genitourinario de la menopausia, se hizo un ensayo clínico controlado aleatorizado y triple ciego. Se asignaron tres grupos (estriol, n=86, lubricante, n=83 y policresuleno, n=82). El principal parámetro indicador de efectividad fue la elevación de la puntuación del índice de salud vaginal (ISV), mejoría de la función sexual de acuerdo al índice de Función Sexual Femenina Abreviado-6 (IFSFA-6), porcentaje de la mejoría de la sintomatología e incidencia de efectos adversos. Resultados: la efectividad fue mayor con el uso del estriol, seguida del policresuleno y menor con el lubricante (92,82 %, 75,69 % y 63,74 %, respectivamente, p = 0,012); también se encontraron diferencias en la mejoría de la función sexual, según los puntajes del IFSFA-6 [29,29 ± 6,23 % (estriol), 28,66 ± 6,12 (policresuleno) y 25,38 ± 6,27 (lubricante), p = 0,021], con diferencias en el porcentaje tanto de la mejoría de la sintomatología como en la presentación de efectos adversos (p = 0,001). Conclusiones: El policresuleno tiene una significativa efectividad en el tratamiento del síndrome genitourinario de la menopausia, superior frente al lubricante, pero inferior al compararse con el estriol. Es evidente la presencia de efectos adversos, siendo menores en el policresuleno frente al estriol, pero mayores al compararlo con el lubricante, sin cuestionar su notable perfil de seguridad.
... Se le ha evidenciado propiedades astringentes, lo que suprime la exudación. Como alternativa no hormonal, en el tratamiento del SGUM, se ha probado su eficacia (76,92%), seguridad, y tolerancia del 91,45% [10]. ...
... En el tratamiento del SGUM, la terapia hormonal está indicada cuando éste se asocia a síntomas vasomotores que afectan la calidad de vida de la mujer [19,20]; pero en los casos persistentes de la sintomatología vaginal local, se puede recurrir a una alternativa adicional como lo es el policresuleno [10]. ...
... Observando los potenciales beneficios del policresuleno más allá de su incuestionable efecto hemostático local [10], de acuerdo con la experiencia clínica multidisciplinaria expresada por Espinosa et al. [21], el que además lo indica como estimulante de la regeneración y re-epitelización tisular con propiedades antimicrobianas y útil en la prevención de la inflamación, así como astringente; sorprende la nula o escasa presencia de investigaciones de su aplicación en una patología tan común en la mujer mayor, como lo es el síndrome asociado al hipoestrogenismo, que en Colombia alcanza cifras alarmantes (51,61%), con 67,2% de asociación a disfunción sexual, según lo publicado por Espitia et al. [3]. ...
Article
Full-text available
Objetivo: dada la relevancia de la inteligencia emocional y de su componente, la empatía, en el quehacer médico, con múltiples beneficios para la adherencia al tratamiento, la relación del profesional consigo mismo, con el paciente y con su entorno, la presente investigación tiene como propósito determinar la inteligencia emocional, mediante el cuestionario EQ-I de Bar-On y la empatía médica - cuestionario de Jefferson, en estudiantes de I a X semestre de medicina de una universidad de la ciudad de Manizales (Colombia). Materiales y métodos: se obtuvo una muestra probabilística de 232 estudiantes, se indagó, además, sobre variables demográficas. Resultados: el valor obtenido de inteligencia emocional promedio fue de 60,38, el 65,5% de la población se ubica en un nivel “muy bajo”, inferior al comparar con estudios análogos, en otras poblaciones de estudiantes de medicina. El valor de empatía médica fue de 95,39 (68,13 valor estandarizado, 4,77 promedio), que resultó comparable con el obtenido en otros estudios. No se encontró relación significativa de ninguna de las dos variables con género, pero sí con semestre, en general el cociente de inteligencia emocional aumenta. Se encontró relación significativa entre la empatía medida por el cuestionario de Jefferson y la subescala de empatía del cuestionario EQ-I de Bar-On. Conclusión: se deduce la relevancia de asignar un mayor peso a la formación humana, dentro del propósito de una formación integral de esta población.
... Es evidente la existencia de mayor mejoría en el grupo «B» respecto al grupo «A» en la puntuación total del IFSF, con menos efectos adversos, además de mejoría clínica en el SGUM, dado que logra el control de los síntomas que afectan la sexualidad; de ahí la sugerencia en utilizar la combinación de tibolona con testosterona, como otra alternativa hormonal, en el manejo del DSH en mujeres en climaterio. Siendo necesario investigar la presencia del SGUM, en aquellas mujeres afectadas en la calidad de vida y su sexualidad, en concordancia a lo reportado por Espitia et al. [34], en una población de similares características demográficas. ...
... La terapia de reemplazo hormonal no aumenta, per se, el deseo sexual ni las fantasías sexuales (35); no obstante, la resolución de los síntomas relacionados con el SGUM, a menudo involucra un incremento del deseo sexual y la excitación (33,34); por otro lado, en este estudio reportamos aumentos significativos, en ambos grupos, en el deseo sexual y en la frecuencia de la actividad satisfactoria, tal como lo reporta Simon et al. (36) con el uso de la testosterona, en mujeres en climaterio, que están recibiendo terapia de reemplazo hormonal, y que presentan trastorno del deseo sexual. En la presencia de DSH en una mujer en climaterio, la terapia reemplazo hormonal puede beneficiarse del aporte de testosterona, observándose mejorías significativas en su libido, lo cual pudimos demostrar en este estudio con ambas terapia, siendo superior con la tibolona, lo que se alinea con lo descrito por Liu et al. (24). ...
Article
Full-text available
Objetivo: evaluar la eficacia y seguridad de dos terapias hormonales sustitutivas, combinadas con testosterona, en el tratamiento del trastorno del deseo sexual hipoactivo en mujeres en climaterio. Materiales y métodos: ensayo clínico, aleatorizado, controlado, no enmascarado. Se incluyeron mujeres mayores o igual a 40 años y menores de 60 años, con útero, con actividad sexual en las últimas seis semanas, aquejadas por síntomas vasomotores, cuyo motivo de consulta consistió en bajo deseo sexual. Se utilizó como instrumento el cuestionario Índice de Función Sexual Femenina (IFSF). Se asignaron dos grupos aleatorizados: grupo «A» (51 recibieron estrógenos conjugados de equinos y medroxiprogesterona más testosterona) y grupo «B» (54 tibolona más testosterona). El estudio fue realizado entre julio de 2015 y diciembre de 2016, en Armenia, Quindío, Colombia. Resultados: se analizó una población de 105 mujeres. La media de edad fue de 55,8 (DS±9,38) años. En la población total, al inicio del estudio, la mediana fue de 3 encuentros sexuales por mes. Al final la mediana fue de 5 encuentros sexuales por mes, (grupo «A» 4 encuentros y grupo «B» 7 encuentros, p=0,0036). Al finalizar la investigación se observó que las mujeres del grupo «B», mostraron puntuaciones promedias significativamente más altas en el IFSF (28,56 DS±4,63 puntos), al compararlas con las mujeres del grupo «A» (27,57 DS±4,32) (p<0,0001). Conclusiones: la terapia con tibolona asociada a testosterona es una opción de tratamiento efectiva en el trastorno del deseo sexual hipoactivo en mujeres en climaterio.
... El policresuleno es un ácido orgánico polimolecular, con actividad hemostática local, y posee un efecto queratoplástico que impulsa el desbridamiento químico selectivo tisular, sin alterar el tejido sano. Estimula la regeneración tisular y el proceso de reepitelización, y tiene propiedades astringentes; suprime la exudación 9 . La cincocaína o dibucaína es un anestésico local del tipo amida. ...
... It removes dead tissue and allows the underlying tissue to coagulate without affecting the healthy squamous epithelium. 5 Therefore, policresulen can be applied to hypergranulation tissue that does not have a normal epithelium. In this study, we evaluated the efficacy of policresulen application in treating hypergranulation at the percutaneous catheter insertion sites. ...
Article
Full-text available
Objective To evaluate the efficacy of policresulen for the treatment of hypergranulation. Method This was a retrospective study of patients with percutaneous catheters. Inpatients from two hospitals and those from outpatient clinics were included. Approximately 2ml of 50% policresulen solution was applied to hypergranulation tissue, which was then immediately pressed with gauze for 1–3 minutes using light pressure. When haemostasis was achieved and the granulation tissue size decreased, the procedure was terminated. Results A total of eight patients (four females and four males) were included in this study. Effective haemostasis was achieved in all patients. The size of the hypergranulation tissue decreased with policresulen treatment, and resolved completely in one patient. There were no complications. Hypergranulation tissue recurred in one patient. Haemostasis was successfully achieved after repeated procedures. Conclusion The findings of this study showed policresulen to be an inexpensive, easy treatment for hypergranulation at catheter insertion sites.
... pp alternativa no hormonal en el tratamiento del SGUM [65]. ...
Article
Full-text available
El síndrome genitourinario de la menopausia (SGUM) describe los síntomas y signos vulvo-vaginales y del tracto urinario inferior, de carácter crónico y progresivo, secundario a un estado clínico de hipoestrogenismo que caracteriza a la postmenopausia. La presente revisión tiene como objetivo describir y analizar las diferentes alternativas terapéuticas no hormonales, con sus ventajas y desventajas, a fin de ofrecerle a los lectores una completa variedad de opciones a la hora de establecer el tratamiento en una mujer con SGUM. Se ha realizado una búsqueda en bases de datos, incluyendo investigaciones originales, consensos de expertos, revisiones sistemáticas y metaanálisis. Se ha revisado la evidencia actual para diversas modalidades terapéuticas farmacológicas y no farmacológicas (no hormonales), encontrando que los hidratantes y los lubricantes son la primera línea terapéutica para proporcionar alivio, a corto plazo, de la sequedad vaginal (leve a moderada) y la dispareunia; sin embargo, el tratamiento ha de ser individualizado. Existen numerosos tratamientos disponibles, cada uno con beneficios y limitaciones y se destacan las sustanciales lagunas, en la evidencia científica, de terapias seguras y efectivas, así como la necesidad de realizar investigaciones futuras.
Article
Full-text available
Genitourinary syndrome of menopause (GSM), previously known as atrophic vaginitis or vulvovaginal atrophy, affects more than half of postmenopausal women. Caused by low estrogen levels after menopause, it results in bothersome symptoms, including vaginal dryness, itching, dyspareunia, urinary urgency and increased frequency, and urinary tract infections. Even though women with GSM can have sexual dysfunction that interferes with partner relationships, women are often embarrassed to seek treatment, and health care professionals do not always actively screen for GSM. As a result, GSM remains underdiagnosed and undertreated. Several effective treatments exist, but low-dose vaginal estrogen therapy is the criterion standard. It is effective and safe for most patients, but caution is suggested for survivors of hormone-sensitive cancers. Newer treatment options include selective estrogen receptor modulators, vaginal dehydroepiandrosterone, and laser therapy. Nonprescription treatments include vaginal lubricants, moisturizers, and dilators. Pelvic floor physical therapy may be indicated for some women with concomitant pelvic floor muscle dysfunction. Sex therapy may be helpful for women with sexual dysfunction. This concise review presents a practical approach to the evaluation and management of GSM for the primary care physician.
Article
Objetivo:Evaluar la eficacia de la combinación de dos terapias estrogénicas locales con un lubricante vaginal (K-Y gel), para el control de los síntomas de la vulvovaginitis atrófica severa.Materiales y métodos:Estudio prospectivo, controlado y aleatorizado. Se incluyeron 57 mujeres posmenopáusicas atendidas en la consulta de climaterio del autor, entre julio de 2014 y julio de 2016. Se establecieron dos grupos, 30 mujeres recibieron 0.625 mg intravaginales de estrógenos equinos conjugados dos veces a la semana (grupo A), y 27 mujeres recibieron estriol a dosis de 0,5 mg intravaginales dos veces a la semana durante seis meses (grupo B). Ambos grupos recibieron, adicional a la terapia hormonal, 5 gramos intravaginales del lubricante cada 6 horas. A todas las mujeres, para evaluar el estatus hormonal, antes del inicio y a los seis meses, se les determinó el índice de maduración vaginal, en simultánea, se le calculaba el índice de salud vaginal, el que se continuó realizando mensualmente en cada control.Resultados:Las mujeres del grupo A mostraron una reducción en la sintomatología, al final del estudio, del 72% frente al 87% del grupo B. Ninguna de las mujeres presentó complicaciones relacionadas con la terapia.Conclusiones:El uso de la terapia estrogénica local, en la vulvovaginitis atrófica severa, es una medida bien tolerada; a los seis meses de seguimiento se pone de manifiesto una mejoría significativa de los síntomas y el índice de salud vaginal. El uso de estriol con lubricante, se asoció con mejores resultados y menores efectos adversos, en comparación con los estrógenos equinos conjugados y el lubricante; no obstante, las tasas de satisfacción sexual fueron similares
Article
Introduction: This study aimed to determine the effects of genitourinary syndrome of menopause on related factors, quality of life, and self-care power. Material and methods: This case-control epidemiological study included 300 postmenopausal women aged 48-60 years who were divided into two groups: the case group (141) with genitourinary syndrome and the control group (159) without genitourinary syndrome. Data were evaluated by chi-square and t-tests in independent groups and logistic regression analysis. Results: The incidence of genitourinary syndrome of menopause was 0.61 times higher in women with a lower educational level than in those with a high educational level, 0.44 times higher in those with chronic disease than in those without, 2.54 times higher in those who continuously used medication than in those who did not, and 2.45 times higher in those with urinary incontinence than in those without. The mean Self-Care Power Scale score was significantly higher in the control group (101.52 ±21.50) than in the case group (83.96 ±25.64). The mean Menopause-Specific Quality of Life Scale score was significantly higher in the case group (65.52 ±33.47) than in the control group (37.06 ±25.81). Conclusions: Low educational level, chronic disease, urinary incontinence, and continuous drug use are associated with genitourinary syndrome of menopause, which negatively affects the quality of life and self-care power in women.
Article
Introducción: El síndrome genitourinario en la menopausia es una condición clínica crónica y progresiva común en las mujeres postmenopáusicas. Objetivo: Revisar los conocimientos para el diagnóstico y tratamiento del síndrome genitourinario en la menopausia. Metodología: Se realizó una búsqueda sistemática en las pincipales bases de datos: Hinari, MEDLINE, Redalyc, NCBI, BVS, SciELO, LILACS, ScienceDirect, Ovid, ProQuest, Bibliomed y Pubmed; también en diferentes revistas electrónicas de medicina con los criterios de búsqueda (tesauros MeSH y DeCS) en español: atrofia vulvovaginal, vaginitis atrófica, vulvovaginitis atrófica y síndrome genitourinario; en inglés: atrophic vulva, atrophic vulvovaginal, urogenital atrophy and genitourinary. Se utilizaron como límites: sexo mujer, idiomas español e inglés, publicados en los últimos 20 años. Se obtuvieron 159 resultados, de los cuales se consideraron 132 relevantes. Resultados: Una vez iniciada la terapia, los síntomas y sígnos del síndrome genitourinario mejoran de forma significativa, observándose mejoras objetivas y subjetivas, tanto vulvovaginales y urinarias, como en el ciclo de respuesta sexual. Conclusión: Los cambios genitorurinarios de la atrofia vulvovaginal postmenopáusica, pueden tener un impacto negativo en la calidad de vida de la mujer, sin embargo, los tratamientos no hormonales y hormonales pueden proporcionar la solución para recuperarse.
Article
Objective: To determine the prevalence of genitourinary syndrome of menopause (GSM) and urogynecological conditions associated with menopause, and to evaluate the impact of GSM on quality of life in a cohort of Spanish postmenopausal women. Methods: Multicenter, cross-sectional, and observational study involving 430 women. Results: The prevalence of GSM was 70%. GSM was diagnosed in 60.2% of women with no known diagnosis of vulvovaginal atrophy or GSM. Most prevalent symptoms were vaginal dryness (93.3%) and reduced lubrication with sexual activity (90.0%). Most prevalent signs were decreased moisture (93.7%) and loss of vaginal rugae (78.4%). GSM was significantly associated with stress or mixed urinary incontinence, overactive bladder, and vaginal prolapse. Symptoms showed a low-moderate impact on quality of life, mainly in sexual functioning and self-concept and body image. Conclusions: The GSM is very prevalent in Spanish postmenopausal women, affecting up to 70% of those consulting the gynecologist. Despite the high prevalence of symptoms and signs and its impact on the women's well-being, GSM remains underdiagnosed and undertreated. Given its relationship with urogynecological conditions, it seems necessary to provide an adequate evaluation of postmenopausal women for identifying potential co-morbidities and providing most adequate treatments. An adequate management of GSM will contribute to an improvement in the quality of life of these women.
Article
Many millions of postmenopausal women continue to suffer in silence from symptoms resulting from estrogen-deficient atrophy of the vulva, vagina and urinary tract whilst the medical profession continues to debate what the condition should be called, how it should be assessed and whether it should be universally treated. It is high time that a unified approach was adopted by all medical societies to reach a consensus on definitions, recognition and management. With the development of the nomenclature for genitourinary syndrome of the menopause (GSM), advances in GSM assessment tools and quality-of-life questionnaires and novel therapeutic interventions, the signs are positive that a new era is finally dawning.
Article
84 Para que la imagen que nos ocupa se genere es condición obligada que el tumor ocupe toda la luz ureteral y que además tenga una estructra vellosa. En los tumores macizos la sustancia de contraste sólo consigue cubrir la superficie del mismo y de hecho origina una imagen negativa (lacunar) que plantea siempre el diagnóstico diferencial con otras semejantes de distinta na-turaleza (litiasis, T. B. C., etc.). En los casos que comentamos, por el contrario, la sustancia de contraste avanza lentamente por la columna ureteral distendida hasta llegar al obstáculo originado por el tumor y allí se insinúa entre cada fimbria del mismo para terminar rellenando por completo todos los espacios. La sustancia de contraste así acumulada, ofrece la suficiente resistencia al paso de los rayos como para generar la imagen que describimos. En resumen: cuando en un ureterograma se observa una imagen en "ca-beza de serpiente" o en "extremo de palillo de tambor", separada de la unión ureterovesical, se puede afirmar la presencia de un tumor ureteral de estruc-tura vellosa, ya que ninguna de las otras expresiones de la patología del uréter es capaz de dar, a ese nivel, una imagen positiva semejante. Nuevas técnicas quirúrgicas, agentes anestésicos modernos, y mayor en-trenamiento debido a la realización de la adenomectomía prostática por equipo de cirujanos especializados en la cirugía urológica, hacen que las complicacio-nes hemorrágicas de las mismas sean cada vez menos frecuentes. La tendencia actual de la movilización precoz en los posoperatorios y la extracción temprana de sondas como profilaxis de procesos tromboembólicos e infecciosos respectivamente, lleva implícita la necesidad de realizar una prolija hemostasia en el acto operatorio, la que debe ser hecha por meticulosa liga-dura de los pedículos vasculares y por electro coagulación de las boquillas ve-nosas residuales de la celda Drostática. Sin embargo resulta casi imposible y hasta imprudente la aplicación de pinzas hemostáticas o electrocoagulación del cabo uretral, en el pico de la próstata. No desconocemos que para ello existen relatados algunos artificios de técnica como el que propusiera A. Puigvert, de anastomosar el cuello vesical al cabo uretral, lo que en nuestras manos y según nuestros conceptos está en el terreno de lo utópico. Es por ello que decidimos ensayar el empleo intra-operatorio de un polímero de condensación del ácido metacresolsulfónico con metanal como hemostático tópico en la cirugía del adenoma de próstata. Este producto posee las siguientes características y propiedades tera-péuticas. Es de elevada acidez (p. h. 0,6) y pese a ello, según experiencias hechas por Warnecke, es inocuo para los tejidos sanos. Esta misma acidez le confiere un alto poder bactericida y de autoesterilización, porque la multiplicación bac-teriana resulta imposible a P. H. menor de 2,5. Es coagulante: Siendo esta acción debida al gran tamaño molecular de este ácido y actúa selectivamente sobre los tejidos necrosados o modificados patológicamente y es intensamente astringente, favoreciendo la retracción de los tejidos, la eliminación del material necrótico y la reepitelización rápida.
Article
Background In 2012, the Board of Directors of the International Society for the Study of Women's Sexual Health (ISSWSH) and the Board of Trustees of The North American Menopause Society (NAMS) acknowledged the need to review current terminology associated with genitourinary tract symptoms related to menopause. Methods The 2 societies cosponsored a terminology consensus conference, which was held in May 2013. Results and conclusion Members of the consensus conference agreed that the term genitourinary syndrome of menopause (GSM) is a medically more accurate, all-encompassing, and publicly acceptable term than vulvovaginal atrophy. GSM is defined as a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids involving changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra and bladder. The syndrome may include but is not limited to genital symptoms of dryness, burning, and irritation; sexual symptoms of lack of lubrication, discomfort or pain, and impaired function; and urinary symptoms of urgency, dysuria and recurrent urinary tract infections. Women may present with some or all of the signs and symptoms, which must be bothersome and should not be better accounted for by another diagnosis. The term was presented and discussed at the annual meeting of each society. The respective Boards of NAMS and ISSWSH formally endorsed the new terminology—genitourinary syndrome of menopause (GSM)—in 2014.
Article
Postmenopausal vaginal atrophy (VA) is a chronic condition with symptoms that include vaginal dryness, soreness, itching, burning, and dyspareunia. The CLarifying Vaginal Atrophy's Impact On SEx and Relationships survey evaluated the impact of VA on the physical and emotional aspects of sexual relationships between postmenopausal women and their male partners. Four thousand one hundred females and 4,100 males representing the United Kingdom, Finland, Norway, Sweden, Denmark, Italy, France, Canada, and the United States were surveyed. Assessments included: (i) talking about VA and its symptoms; (ii) the impact of VA on intimacy, relationships, and women's self-esteem; (iii) talking about VA and erectile dysfunction (ED); and (iv) the impact of local estrogen therapy (LET) on intimacy and relationships. Descriptive data on the impact of VA. Twenty-eight percent of women did not tell their partners when they first encountered vaginal discomfort, mainly because they felt "it was just a natural part of growing older" (52%) or because of "embarrassment" (21%). Eighty-two percent of males wanted their partner to share their experiences with VA; males were also more comfortable discussing VA than females (68% vs. 58%, respectively). Having sex less often (women: 58%, men: 61%), less satisfying sex (women: 49%, men: 28%), and putting off having sex (women: 35%, men: 14%) were the main effects of VA. Intimacy avoidance was attributed to painful sex (women: 55%, men: 61%) and women's reduced sexual desire (women: 46%, men: 43%). Discussions about vaginal discomfort and ED were generally limited to partners and healthcare providers (HCPs). LET use resulted in less painful sex (women: 62%, men: 59%) and more satisfying sex (women: 47%, men: 49%). VA has an adverse emotional and physical impact on postmenopausal women and their partners. These findings may encourage more open communication about VA between couples and their HCPs. Nappi RE, Kingsberg S, Maamari R, and Simon J. The CLOSER (CLarifying Vaginal Atrophy's Impact On SEx and Relationships) survey: Implications of vaginal discomfort in postmenopausal women and in male partners. J Sex Med **;**:**-**.
Article
Seven centres investigated the therapeutic efficacy and tolerability of policresulene associated to cinchocaine administered locally as ointment, suppositories or both formulations in 2287 patients with hemorrhoid pathology. The studies were conducted with a standardised protocol and case report forms and with the same score criteria for rating efficacy and tolerability according to the physicians and the patients. Highly satisfactory results were achieved in 1904 patients (83.2%) according to the investigators criteria. Patients rated the outcome most satisfactory for 1881 cases (82.2%). The following were found to be the principal indications: external and internal hemorrhoids associated with bleeding, acute anal fissures, rhagades and perforated or incised perianal thrombosis, anal eczema and anal pruritus, proctitis and wound treatment after proctologic surgery. None of the investigators found any serious adverse event. Mild to moderate adverse reactions in 10% of the patients were local discomfort, pruritus, burning or irritation. Such symptoms occurred at the beginning of treatment. The favourable effects of policresulene are attributed to its unique mechanism of action. The highly acid characteristics of the substance causes a selective coagulation of the necrotic tissues leaving healthy tissues unaffected. The desquamation and remotion of the necrotic tissues induces rapid wound cleansing, and a reactive hyperemia of the treated area enhancing epithelization. Its highly acid pH produces a marked bactericidal action on the most common pathogens and C. albicans as well. Policresulene has hemostyptic properties producing vasoconstriction of the myofibrils of the blood vessels arresting profuse bleeding from large areas. The local anesthetic cinchocaine contributes to the initial pain relief. None of the formulations contains corticosteroids which makes this preparations also suitable for long term treatment periods.