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Neurourology and Urodynamics. 2020;1–9. wileyonlinelibrary.com/journal/nau © 2020 Wiley Periodicals LLC
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1
Received: 11 March 2020
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Accepted: 6 May 2020
DOI: 10.1002/nau.24389
ORIGINAL CLINICAL ARTICLE
Early 3‐month treatment with comprehensive physical
therapy program restores continence in urinary
incontinence patients after radical prostatectomy:
A randomized controlled trial
Mercedes Soto González PhD
1
|Iria Da Cuña Carrera PhD
1
|
Manuel Gutiérrez Nieto PhD
1
|Sabela López García
2
|
Antonio Ojea Calvo PhD
2
|Eva M Lantarón Caeiro PhD
1
1
Department of Functional Biology and
Health Sciences, Faculty of Physiotherapy,
University of Vigo, Vigo, Spain
2
Urology Service, University Hospital
Complex of Vigo, Vigo, Spain
Correspondence
Iria Da Cuña Carrera, PhD, Faculty of
Physiotherapy. University of Vigo,
Campus A Xunqueira s/n,
CP 36005 Pontevedra, Spain.
Email: iriadc@uvigo.es
Funding information
Official College of Physiotherapists of
Galicia (Spain), Grant/Award Number:
17032017
Abstract
Aims: The objective of this study is to ascertain whether an early three‐month
treatment with electrotherapy and biofeedback restores continence in urinary
incontinence patients after radical prostatectomy (RP).
Methods: Design: The study performed a randomized, controlled trial of
parallel and open groups.
Configuration: Secondary care, urology department of a university hospital
complex.
Participants: Patients sent for RP due to prostate cancer (n = 60), 47 patients
finally completed the study.
Interventions: The treatment group (TG) received physiotherapy consisting of
electrotherapy and biofeedback, 3 days a week for 3 months, while the control
group (CG) received no specific treatment. Both groups received a guide to
perform pelvic floor exercises at home. The measurement instruments used
were the 1‐and 24‐hour pad tests and the International Consultation on In-
continence Questionnaire Short‐Form. The recording method used was a
micturition (urinary) diary.
Results: The results of the 1‐hour pad test (PT) show statistically significant
differences between groups at 3 months (P= .001) and 6 months (P= .001), in
favor of those in the TG. Sixty‐four percent of patients in the TG recovered
continence as against 9.1% in the CG after 3 months in the 1‐hour PT, in line
with the objective of this study.
Conclusions: An early physiotherapy program helps RP patients with urinary
incontinence recover continence after 3 months. Moreover, they lead a better
quality life.
KEYWORDS
physical therapy modalities, prostatectomy, urinary incontinence, urology
1|INTRODUCTION
Prostate cancer is the second most diagnosed cancer in
men worldwide and the first in Europe and Spain. Its
early detection, thanks to the use of PSA and subsequent
biopsy, caused the incidence rate to increase significantly
in the 1990s
1
but led to significant decrease in mortality.
2
According to the latest data, prostate cancer currently
has a high cure rate, where the relative survival at 5 years
is almost 100%. This is because 90% of the cases are di-
agnosed in the localized stage, meaning that the cancer
has not yet spread outside the prostate gland, which
would explain the high survival rate.
3
Radical prostatectomy (RP) has become the “gold
standard”to treat prostate cancer and seems to be the
best method for cancer control in the long term. How-
ever, this procedure is not exempt from morbidity, since
urinary incontinence affects patient's quality of life.
4
Data on urinary incontinence rates after RP are dis-
parate and have been the source of controversy in
recent years. Rodriguez Escobar
5
explains that the reason
behind the wide range in incontinence incidence is the
use of different definitions of continence and methods for
quantifying it, where one can find definitions, such
as “total control,”“occasional leakage but without pad,”
and “less than one pad.”
From a medical point of view, incontinence causes
skin irritation, chronic dependence on catheters and ur-
ine collecting devices, and a significant increase in mor-
bidity. The cost of this pathology (materials, nursing care,
diagnostic tests, treatments, etc) in the United States has
been directly or indirectly estimated to be about 8 billion
dollars a year.
6
The conservative treatment today for post‐
prostatectomy urinary incontinence includes training of
the pelvic floor muscles, biofeedback (BF), and electro‐
stimulation. The above must be combined with a proper
life style that includes a decrease or elimination of caf-
feine, tobacco, performance of physical exercise and
bladder training, creation of a voiding schedule, and
gradually increasing voiding interval.
7
The objective of this study is to ascertain whether an
early three‐month treatment with electrotherapy (ET) and
BF restores continence in RP patients with urinary
incontinence.
2|MATERIALS AND METHODS
A randomized controlled trial of parallel and open groups
was carried out, to compare the efficacy of physiotherapy
intervention in improving continence in patients who un-
derwent RP due to prostate cancer. The study is registered in
Assign ISRCTN with reference ISRCTN48761809, https://
doi.org/10.1186/ISRCTN48761809.
Power calculation was based in the study of Manassero
et al,
8
showing a 67% of continence at 3 months in patients
undergoing RP in the group with physiotherapy treatment
and 22.5% in the control group (CG). Assuming a 95%
confidence level, 80% potency and a 1:1 treatment and
control ratio, 56 patients would need to be included in
each of the groups. Assuming a percentage of losses during
the follow‐up of 20% of these groups should be 67.
Statistically significant results were achieved before
reaching the calculated sample size, and therefore it was
decided to stop the clinical trial.
9
The sample consisted of 60 patients (two groups of
30 patients each) who underwent RP surgery at the
Complejo Hospitalario Universitario de Vigo. Only RP
patients with stress incontinence who consented to par-
ticipate in the study were included, those with neurolo-
gical pathology, such as advanced Parkinson's disease,
multiple sclerosis with deterioration of cognitive or sen-
sitive abilities or with muscular weakness were excluded.
Also excluded were patients with other serious illnesses,
such as cancer, severe chronic obstructive pulmonary
disease, severe pulmonary hypertension, etc, patients
with pacemakers, patients treated with muscle relaxants,
and patients with previous urinary incontinence.
Five patients from the CG declined participation upon
learning that they would not be part of the experimental
group, while one had to receive chemotherapy and
two had urinary continence. In the experimental
group, three patients manifested urinary continence and
two received chemotherapy. Finally, as shown in
Figure 1, the sample consisted of 47 males, 25 from the
treatment group (TG), and 22 from the CG.
All patients signed the informed consent form ap-
proved by the Regional Committee on ethics and re-
search of Galicia before participation in any of the study
procedures. Patients, doctors, and evaluators were not
blinded for treatment. We expect no limitation of results
since the main outcome variables are completely objec-
tive. All patients were subject to the same measurements
and evaluations, irrespective of the group to which they
belonged.
The urinary catheter was removed 3 weeks after RP
and patients were subject to physiotherapy protocol
4 weeks after surgery.
The measurement instruments used were the 1 and
24‐hour pad tests, following recommendations of the
International Continence Society and the International
Consultation on Incontinence Questionnaire Short‐
Form (ICIQ‐SF) validated for the Spanish language.
Moreover, the recording method used was a micturition
diary.
2
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GONZÁLEZ ET AL.
Measurements were carried out at the start of treat-
ment, and after 1, 2, 3, and 6 months. Initial measure-
ment and treatment, in the case of the experimental
group, began 7 days after catheter removal since im-
mediate measurements may not be representative of later
urinary incontinence.
The treatment group received physiotherapy consist-
ing of electrotherapy and BF, 3 days a week for 3 months,
while the CG did not receive any specific treatment, but
both groups received a printed guide to perform pelvic
floor exercises (PFEs) at home.
The intervention consisted of a first awareness phase
where patients received basic notions of anatomy, func-
tioning of the musculature and the process of urination,
and were then given recommendations on control of
liquid intake, limitation of substances, such as coffee,
alcohol, etc, and instructions on how to fill in the urinary
diary. Moreover, they were trained to perform a reliable
contraction, that is to say, perform contraction of the
pelvic floor muscles, by avoiding parasitic contractions of
buttocks, abdominals, adductor muscles, etc. This phase
was adapted to each patient since getting quality con-
traction is of utmost importance here.
Patients received ET every alternate day, that is, for
15 minutes 3 days a week, with square wave pulses of
20 Hz, 300 ns pulse duration and maximum intensity of
24 mA. This was because the literature review indicates this
to be the type of electro‐stimulation that gets best results.
Electromyography BF: the duration of treatment with
BF was approximately 30 minutes every day and patient
gradually exercised for strength, endurance and speed to
obtain the objectives.
PFEs should be in line with the patient's muscular
condition, and hence should vary in terms of force of
contraction, duration of contraction, pause times, speed
and position adopted by adapting to the muscle condition
of each patient. These exercises were done at home
three times/day spread over several sets.
2.1 |Statistical analysis
Data were analyzed with SPSS version 22. The Shapiro‐
Wilk test was used to check the distribution of sample
normality. The descriptive statistics of the quantitative
variables are provided through the mean and standard
FIGURE 1 Study flow chart of the
patients in the study. Number of patients (n)
GONZÁLEZ ET AL.
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3
deviation, while qualitative variables are expressed as
percentages. The Wilconson test compared the results of
urinary incontinence between the two groups at the start
of treatment, after 1, 2, and 3 months. A Pvalue of .05
was considered as statistically significant.
3|RESULTS
The relationship between the treatment and CGs at
baseline and before start of treatment did not show sig-
nificant differences in any of the measurement instru-
ments used: 1‐hour pad test (P= .641), 24‐hour pad test
(P= .983), and ICIQ‐SF (P= .079) (Table 1).
The results of the 1‐hour pad test show statistically
significant differences between groups at 3 months
(P= .001) and 6 months (P= .001) in favor of the treat-
ment group (Table 1). Figure 2shows the evolution of
urine loss by group and time.
With regard to continence rates after 3 months in the
1‐hour PT, and in relation to the objective of this study,
64% of patients in the TG recovered continence as against
9.1% in the CG.
The results with the 24‐hour pad test show significant
differences between groups after 3 months (P= .003) and
6 months (P= .001), once again in favor of the treatment
group (Table 1; Figure 3).
However, if we take into account continence rates at
3 months for the 24‐hour pad test, the figure is 44% in the
treatment group, which is lower than that seen in the
1‐hour pad test. There is nevertheless evidence of dif-
ference between groups, since the CG reported a 4.5%
continence rate.
Finally, the results of the ICIQ‐SF scores show sig-
nificant differences between groups at 2 months (P=.014),
3months(P= .001), and 6 months (P= .0001), once again
in favor of the treatment group (Table 1and Figure 4).
4|DISCUSSION
The results of the 1‐hour pad test show statistically sig-
nificant differences at 3 months, which was the deadline
for achieving the continence objective in this study. Hence,
a comparison of continence rates from the different studies
for this period showed a large difference, where the best
results were obtained by Kongtragul et al
10
and Van
Kampen et al
11
at 95% and 88%, respectively. With regard
to the intervention, worth mentioning is that Kongtragul
et al
10
only used PFE while Van Kampen et al
11
combined
it with BF. Also noteworthy is the exercise intensity, since
in Kongtragul et al
10
patients performed 240 contractions/
day, while those of Van Kampen et al
11
only performed
90 contractions/day, which may explain the better results.
As shown in the section on results, the present study
obtained 64% continence in the 1‐hour pad test at
3 months, which is slightly lower than the one obtained
in the mentioned studies, but it must be borne in mind
that continence is defined as 0 g of loss. For studies using
the same definition but with different tools (score 0 in the
TABLE 1 Contrast of means between groups in PT1 h, PT24 h, and ICQSF
Variable Time n (TG) Mean ± te (TG) n (CG) Mean ± te (CG) CI 95% Pvalue
1‐h PT Start, mo 25 72.48 ± 19.24 22 61.09 ± 15.64 −11.39 [−60.29, 37.51] .741
1 25 26.76 ± 6.43 22 56.00 ± 16.26 29.24 [−5.79, 64.27] .162
2 25 13.12 ± 4.10 21 51.67 ± 15.77 38.55 [5.62, 71.47] .069
3 25 4.64 ± 1.83 20 35.30 ± 9.91 30.66 [10.19, 51.13] <.001*
6 23 0.70 ± 0.35 18 19.50 ± 7.34 18.80 [3.75, 33.86] <.001*
24‐h PT Start, mo 25 465.48 ± 99.23 22 443.91 ± 93.16 −21.57 [−289.81, 246.67] .983
1 25 258.60 ± 66.65 22 352.64 ± 111.65 94.04 [−164.11, 352.18] .565
2 25 128.64 ± 38.98 21 276.38 ± 81.28 147.74 [−32.30, 327.78] .242
3 25 27.32 ± 11.69 20 196.70 ± 65.40 169.38 [34.38, 304.38] .003*
6 23 4.00 ± 1.50 18 107.78 ± 43.00 103.78 [15.58, 191.97] <.001*
ICIQ‐SF Start, mo 25 13.48 ± 0.80 22 15.36 ± 0.70 1.88 [−0.20, 3.97] .079
1 25 12.32 ± 0.66 22 13.77 ± 0.68 1.45 [−0.42, 3.32] .102
2 25 9.28 ± 0.86 21 12.48 ± 0.93 3.20 [0.69, 5.70] .011*
3 25 5.68 ± 0.86 20 12.20 ± 0.77 6.52 [4.24, 8.80] <.001*
6 23 3.87 ± 0.84 18 9.94 ± 1.12 6.07 [3.31, 8.84] <.001*
Note: The Pvalue refers to the difference between the groups. *P< .05.
Abbreviations: CG, control group; CI, confident interval; ISIO‐SF, International Consultation on Incontinence Questionnaire Short‐Form; n, number of
patients; PT, pad test; te, typical error; TG, treatment group.
4
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GONZÁLEZ ET AL.
FIGURE 2 Evolution of urine loss by
group and time in the 1‐hour pad test (PT)
FIGURE 3 Evolution of urine loss by
group and time in 24‐hour PT. PT, pad test
GONZÁLEZ ET AL.
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5
ICIQ and no loss recorded in the urinary diary), the rates
were slightly lower, such as 59.3% reported by Cen-
temero, 57.7% by Pedrialli, 50% by Tienforti, and 43.6% by
Dijkstra‐Eshuis. The first two authors performed inter-
ventions consisting of preoperative PFE and PFE +
ET + BF, while the latter two authors performed inter-
ventions with BF + PFE.
The results with the 24‐hour pad test show that
there are significant differences between groups after
3 and 6 months, once again in favor of the treatment
group. The continence rate at 3 months with this test in
the present study was 44%. There is a group of authors
who used this test and obtained similar continence
rates of between 40%‐50%,
8,12‐14
and as can be seen,
these rates are lower than those achieved with the
1‐hour pad test.
Filocamo et al
15
and Cornel et al,
16
respectively re-
ported 74% and 70% continence at 3 months, which is the
exception. However, it must be borne in mind that even
though Filocamo et al
15
used the 24‐hour pad test tool,
they grouped patients who used one diaper/day under
continence and this could clearly bias results. In the case
of Cornel et al
16
and Mariotti et al,
14
who obtained a rate
of 63%, both classified continence as losses of less than or
equal to 2 g, which could justify the higher rates when
compared with the present study, which classifies con-
tinence as 0 g of loss or a completely dry pad.
On the other hand, Yamanishi et al
17
and Terzoni
et al
18
achieved rates of around 63% but their definition of
continence differs greatly from the rest of the studies
(carried out in males). The former considered continence
as ≤8 g, (the definition accepted at the time for females
which took into account the weight of the vaginal flow)
which cannot be applied in the case of males since it
would skew this percentage. The latter included all
patients with less than 10 g loss/day, which again pre-
vents any comparison.
There seems to be a noticeable difference in rates
depending on the pad test used. This coincides with a
previous study conducted by Soto et al,
19
where the dis-
crepancy in continence rates depended on whether it was
measured with the 1‐or 24‐hour pad test; a higher per-
centage of continence was observed for the 1‐hour pad
test. However, this fact would not alter the significant
differences found between the study groups.
The initial conditions of both groups in the present
study were similar in terms of loss evidenced in all
measurement instruments used. Moreover, based on the
mean loss in grams reflected in the different studies, we
can observe that they are quite similar for the 24‐hour
FIGURE 4 Evolution of urine loss by
group and time in International Consultation
on Incontinence Questionnaire Short‐Form
(ICIQ‐SF)
6
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GONZÁLEZ ET AL.
pad test, since they vary between 217 and 287 g in most
studies that refer to this variable.
7,8,12,20‐22
These data are
below the mean loss observed in the present study since it
lies at 465.48 ± 99.23 for the treatment group and
443.91 ± 93.16 for the CG. Therefore, the level of severity
of incontinence is greater in this sample. Yokoyama
et al
23
reported losses of 680 g, which is a much higher
figure than the means in the rest of the studies, but it
should be noted that this amount corresponds to the
first day of urinary catheter withdrawal. Most studies per-
formed measurements 1 week after catheter withdrawal, to
obtain a more realistic measure of incontinence.
Authors that used the 1‐hour pad test observed means
that lay between 28
24
and 40 g,
25
and once again, our study
indicates a higher severity level, since the mean is
72.48 ± 19.24 g for the treatment group and 60.69 ± 15.64 g
for the CG.
This indicates that baseline losses are not homogeneous,
thereby revealing differences in the initial severity of pa-
tients from the different studies, which may also affect the
results obtained and prevent any comparison. It is striking
that many studies do not specify the initial losses although
they do use tests that include them.
10,13,16,18,20,26‐28
The interventions that reported best results combined
PFE + BF,
11,16
BF + ET,
20
but the intervention that ob-
tained the best results is an intensive PFE program.
10
The ICIQ‐SF results show significant differences at
2 months in favor of the intervention group, in studies
that used this same questionnaire for assessment of ur-
inary incontinence,
13,17,21,29,30
where significant im-
provements were observed after the first month. At this
point, it should be emphasized that this tool obtains
improvements before those obtained objectively in the
1‐and 24‐hour pad tests. This could be due to the specific
question related to quality of life, that is, the patient
perceives an improvement even though it may not be
significant. Earlier studies found discrepancies in the
severity level determined by the ICIQ‐SF and the pad
tests, since they do not coincide much.
31
The most commonly used methods to treat urinary in-
continence are ET, BF, and PFE, which have been studied
traditionally in the treatment of female incontinence but, as
we shall see below, they have also been evaluated in the
treatment of male urinary incontinence after RP.
Electrotherapy has shown its effectiveness in various
studies,
7,17,20,23,29,32
although most studies used a com-
bination of ET + PFE to obtain better results.
20,29
As an
exception, Goode et al
33
reported that the addition of PFE
to an ET program did not increase continence rates, but
ET in this case was performed by the patient himself at
home, which could affect the results. But what seems
evident is that ET is the most appropriate treatment when
muscle weakness is pronounced.
34
Many articles report that BF has been used in the treat-
ment of male urinary incontinence
11,14,16,20,25,26,30,33,35‐38
and
the benefits of this therapy are that it facilitates learning of
PFEs, giving the patient the possibility to conduct self‐
assessments, thereby increasing motivation towards treat-
ment.
39
There are diverse results after application of BF, with
positive result in the most of the studies,
11,16,20,26,30,37
when
used on its own or combined with other treatments.
A group of authors did not find benefits after addition
of BF to their interventions. All these studies performed a
total of 1 to 5 BF sessions
14,33,35,38
which may be the
cause of the ineffectiveness of the technique since the
number of sessions seems to be less than that required for
obtaining good results. On the other hand, the effective
studies had carried out between 1 to 2 sessions/week,
over a 3 month interval.
11,16,20,16,29,40,15,28,39
Many studies
do not provide details of therapy implementation and
hence cannot be reproduced.
Finally, PFE are the most widely used treatment for
treating male urinary incontinence with good results in
all studies that include them as sole treatment or com-
pare them with placebo or no intervention.
The performance of PFEs is considered as one of the
most effective treatments today.
Although earlier literature reports that there is no
established protocol on duration of contractions, resting
time or the number of repetitions or sets, García‐Sánchez,
after reviewing several articles related to therapeutic PFE,
provides a protocol of 30 to 40 contractions four times/
day. A maximum of 200 contractions/day and up to
300 contractions/day in athletic women
41
could justify
the better results obtained with a more intensive program
as seen above.
The fact is that patients who perform exercises at
home cannot be controlled for adherence to the exercise
program, which may affect treatment results.
5|CONCLUSION
An early physiotherapy program helps recover continence
after 3 months in urinary incontinence patients that under-
went RP. Moreover, these patients lead a better quality life.
ACKNOWLEDGMENT
This study has received funding from a research com-
petition of the Official College of Physiotherapists of
Galicia with a resolution of 17 March 2017.
CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.
GONZÁLEZ ET AL.
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7
ETHICS STATEMENT
Regional Committee on ethics and research of Galicia
(IBAC). Reference number: 2014/351.
ORCID
Mercedes Soto González http://orcid.org/0000-0001-
6541-988X
Iria Da Cuña Carrera http://orcid.org/0000-0002-
9507-789X
Manuel Gutiérrez Nieto http://orcid.org/0000-0001-
6020-808X
Eva M Lantarón Caeiro http://orcid.org/0000-0002-
5625-7628
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How to cite this article: Soto González M, Da
Cuña Carrera I, Gutiérrez Nieto M, García SL,
Calvo AO, Caeiro EML. Early 3‐month treatment
with comprehensive physical therapy program
restores continence in urinary incontinence
patients after radical prostatectomy: A randomized
controlled trial. Neurourology and Urodynamics.
2020;1–9. https://doi.org/10.1002/nau.24389
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