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75NC007 device for noninvasive stress urinary incontinence management in women: A randomized controlled trial

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  • Centre Hospitalier Universitaire de Clermont-Ferrand, hôpital Estaing, FRANCE

Abstract and Figures

Introduction and hypothesis Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management. Methods A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. Results Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (−31.7 ± 65.1 % vs −7.6 ± 24.5 %, p = 0.002, −2.4 ± 2.6 vs 0.2 ± 2.2, p = 0.004, and −1.5 ± 2.8 vs 0.2 ± 1.8, p = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. Conclusions The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.
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ORIGINAL ARTICLE
75NC007 device for noninvasive stress urinary incontinence
management in women: a randomized controlled trial
Jean-Nicolas Cornu &Stéphane Mouly &
Gérard Amarenco &Bernard Jacquetin &Calin Ciofu &
Francois Haab &the 75NC007 Study Group
Received: 28 November 2011 /Accepted: 22 April 2012
#The International Urogynecological Association 2012
Abstract
Introduction and hypothesis Management of stress urinary
incontinence (SUI) with intravaginal devices is an alterna-
tive to surgical management, but data of a high level of
evidence remain scarce. Our goal was to assess efficacy,
tolerance, and acceptability of the 75NC007 intravaginal
device for SUI management.
Methods A phase III, multicenter randomized controlled
trial was conducted. After an initial washout period with
no treatment, allowing baseline evaluation, women with
SUI were randomly assigned to a treatment or control group
(no treatment). The primary endpoint was the reduction of
incontinence episode frequency (IEF), according to bladder
diaries, as compared to baseline. Secondary endpoints were
variation of the Urinary Symptom Profile (USP) score, of
24-h pad test, and of CONTILIFE questionnaire scores as
compared to baseline. Intent-to-treat and per-protocol anal-
yses were conducted.
Results Fifty-five patients were enrolled and analyzed (26
controls and 29 treated). The mean relative variations of
IEF, SUI USP subscore, and overactive bladder (OAB)
USP subscore were more significant in the treatment group
than in the control group (31.7±65.1 % vs 7.6 ± 24.5 %,
p00.002, 2.4±2.6 vs 0.2±2.2, p00.004, and 1.5 ± 2.8 vs
0.2±1.8, p00.016, respectively). The dysuria USP subscore
was slightly decreased in the treatment group. CONTILIFE
scores were slightly improved in the treatment group. Pad
test variations were not different between groups. No seri-
ous adverse event was noted throughout the entire study.
Conclusions The 75NC007 intravaginal device is a safe and
effective noninvasive treatment of SUI in women.
Keywords Intravaginal device .Noninvasive .Outpatient .
Stress urinary incontinence
Introduction
The prevalence of urinary incontinence is high and
increases with age [1,2]. Urinary incontinence has a
J.-N. Cornu :C. Ciofu :F. Haab
Department of Urology, Tenon Hospital, Assistance Publique-
Hôpitaux de Paris, University Pierre-et-Marie-Curie Paris 6,
4 rue de la chine,
75020 Paris, France
S. Mouly
Department of Internal Medicine, Lariboisière Hospital,
Assistance Publique-Hôpitaux de Paris, University Sorbonne Paris
Cité-Diderot,
2 rue Ambroise Paré,
75010 Paris, France
G. Amarenco
GREEN Groupe de recherche clinique en neuro-urologie, GRC
UPMC, University Pierre-et-Marie-Curie Paris 6, Neuro-urology
Unit, Tenon Hospital, Assistance Publique-Hôpitaux de Paris,
4 rue de la Chine,
75020 Paris, France
B. Jacquetin
Uro-gynecology Unit, CHU Estaing 1, place Lucie-Aubrac,
63100 Clermont-Ferrand, France
J.-N. Cornu (*)
Urology Department, Tenon Hospital,
4 rue de la Chine,
75970 Paris Cedex 20, France
e-mail: jeannicolas.cornu@gmail.com
Int Urogynecol J
DOI 10.1007/s00192-012-1814-z
negative impact on patient quality of life [3,4]. Of the
different forms of urinary incontinence, stress urinary
incontinence (SUI) is the most frequently reported by
women [2]. According to expert panels [5], behavioral
therapy and/or pelvic floor muscle training is the first-
line treatment for SUI. Although surgical management
by midurethral slings is highly effective after failure of
conservative measures [2,6,7], some patients refuse or
delay surgical intervention for various medical or per-
sonal reasons. In these cases, nonsurgical options in-
clude drugs, mainly limited to duloxetine, which is the
only drug available in Europe for SUI management [8,
9], urine-absorbing products, and intravaginal devices or
pessaries. Mechanical devices could also be an appropriate
option for patients with mild or infrequent intermittent leak-
age, for instance, in connection with physical activity.
Intravaginal devices were shown to be effective for
SUI management when compared with behavioral ther-
apy and represent a promising alternative or comple-
mentary nonsurgical approach [1013]. These devices
are believed to act as a support for the urethra and
bladder neck during peaks of intra-abdominal pressure
[14]. However, this conservative treatment option is
underutilized not only because of the limited knowledge
of practitioners about its efficacy and indications [11],
but also because data on efficacy of such intravaginal
devices for SUI remain scarce, especially those obtained
through randomized comparative studies [10,15].
The primary aim of the present study was to evaluate the
efficacy of a new intravaginal device for the management
SUI. Secondary objectives were to determine its tolerance
and acceptability.
Materials and methods
Population
Sixty-eight patients, consulting for self-reported urinary
incontinence, were screened to participate in this multi-
center, prospective, randomized controlled trial. During
an initial 14-day washout period (Fig. 1)episodesof
urine leakage were recorded in a bladder diary and a
24-h pad test was performed. Before enrollment and
randomization, complete medical history was assessed,
conformity with selection criteria (Table 1) checked, and
written informed consent (WIC) obtained. Participants
also completed the Urinary Symptom Profile (USP)
[16] and CONTILIFE questionnaires [17]. The protocol
was approved by the local Institutional Review Board.
The trial was declared to and registered with French
authorities [Afssaps, N°2006/04/012 (www.afssaps.fr)].
Intravaginal device description
The investigational device, made of thermoplastic elastomer
(ref. 75NC007, Fig. 2) was supplied in two sizes (medium
and small). Depending upon patient preference the device
has to be inserted into the vagina with or without the help of
an applicator. Once inserted, it automatically locates beneath
the urethra (cylindrical and proximal part) and bladder (ring-
shaped and distal part) and thus constitutes a support for the
urethra and bladder neck. It is removed by pulling on the
string fixed in the cylindrical part of the device.
Study design (Fig. 1)
After a washout period (P1), patients were enrolled and
randomly assigned to either the treatment or the control
arm for 14 days (P2). Computerized randomization was
centralized by the data coordinating center. Efficacy was
assessed in the two parallel groups at the end of P2. Then,
Fig. 1 Study design (visits and study periods)
Table 1 Inclusion criteria
Age 18 or more
SUI assessed by clinical examination (stress test) with more than
8 incontinence episodes on 2-week bladder diary (at least 4/week)
Mixed urinary incontinence with predominant SUI component
Postmenopausal or under contraception
No vaginal delivery in the past 2 months
No bladder or vaginal active disease
No acute or recurrent urinary infection
(negative dipstick urine analysis)
No pelvic organ prolapse stage II according to the Pelvic Organ
Prolapse Quantification classification
No surgical intervention for SUI in the past 6 months
No drug treatment for urinary incontinence in the last month
No pelvic floor muscle training under way
SUI stress urinary incontinence
Int Urogynecol J
all patients were treated with the device for another 14-day
period (P3). Tolerance and acceptability of the device were
estimated at the end of P3. The patients were asked to
maintain their usual physical activity during the study, and
the device had to be worn at least 6 h a day, with a maximum
of 24 h, then changed on a daily basis.
The primary endpoint was the relative variation of the
number of incontinence episodes per week [incontinence
episode frequency (IEF)], recorded in the bladder diaries
of both periods (P2 vs P1). Secondary outcome measures
were (a) variation of the USP subscores [SUI, overactive
bladder (OAB), and dysuria], (b) device efficacy assessed
by patients on a continuous visual analogue scale from 0 (no
improvement) to 100 (very important improvement), (c)
variation of 24-h pad test (P2 vs P1), and (d) variation of
all subscores of the CONTILIFE questionnaire (P2 vs P1).
Tolerance and acceptability were evaluated after P3 as
follows: first, all adverse events were recorded throughout
the study for objective evaluation of tolerance. Then, the
practitioner had to subjectively evaluate the global tolerance
at the end of the study (graded as excellent, good, moderate,
or poor). Acceptability was graded as excellent, good, mod-
erate, or poor, based on several criteria, i.e., ease of use of
the device and its applicator, compatibility of employment
of the device with normal life, ease of vaginal placement,
comfort of use, and ease of removal. Interference with
sexual intercourse and interest in buying the device (in case
of non-reimbursement) were also evaluated. Finally, patient
satisfaction, with respect to treatment efficacy, as expressed
by the patients themselves by using a continuous visual
analogue scale ranging from 0 to 100, was also evaluated.
Statistical analysis
On the basis of previous results obtained with intravaginal
devices [10] showing an efficacy of 40 % and assuming a
20 % dropout rate, the required sample size was estimated to
be 60 patients to reach a power of 90 % with a type I error
probability of 5 %. Statistical analyses were implemented in
Statview v8.0 (SAS Institute, Cary, NC, USA). Separate
analysis was performed in the intent-to-treat (ITT) and the
per-protocol (PP) analysis sets. Comparisons between
groups were performed by using Studentsttest or the
Wilcoxon signed rank test, as appropriate, for quantitative
variables and by the chi-square test or Fishers exact test, as
appropriate for qualitative variables. Differences were con-
sidered as statistically significant if p< 0.05.
Results
Between September 2006 and December 2008, 68 patients
were initially screened by 12 investigators/study centers. At
V2, 55 patients were enrolled and randomized. During P2
12 patients of the treatment group did not use the device
and/or collect data in their bladder diary as required
(i.e., use <6/24 h, >50 % of missing data, Table 2).
Two patients in the control group withdrew from the
study for personal reasons and did not complete their
bladder diary either (Table 2). Hence, the ITT and PP
data sets included 55 and 41 patients, respectively
(Fig. 3). Except for height, diastolic blood pressure,
hysterectomy, and OAB symptoms, the two groups were
comparable at baseline for all remaining items tested,
including the CONTILIFE scores (Table 3).
Primary endpoint
Comparison of the IEFs of P2 and P1 showed a signif-
icant difference between the mean reduction rates of the
treatment and control groups, respectively [31.7±
65.1 % (100; +155) vs 7.6±24.5 % (67; +35), p0
0.0023] in the ITT analysis. This difference was also
noted in the PP analysis (Table 4). When adjusted to
hysterectomy and OAB symptoms, the difference ob-
served in the primary endpoint did not change.
Secondary endpoints
The variations of secondary outcome parameters are described
in Table 4for both ITT and PP analysis. In both data sets, the
USP questionnaire showed that the mean SUI subscore de-
creased more in the treatment group than in the control group.
Similarly, mean OAB subscore and mean dysuria subscore
also decreased more importantly in the treatment arm. By
contrast, no significant difference was found for the mean
24-h pad test relative variation in the two groups. Patient
satisfaction, with respect to treatment efficacy, was much
higher in the treatment group than in the control group.
Fig. 2 The device and its applicator
Int Urogynecol J
The impact on quality of life as evaluated by the variation
of CONTILIFE questionnaire items, measured in patients
who really used the device at least 6 h a day is shown in
Tab le 5. There was a trend towards an improvement of
global score of quality of life among patients treated with
the intravaginal device.
Tolerance
Adverse events linked to the procedure were limited to one
case of metrorrhagia in one postmenopausal patient treated
with the device and one case of urinary tract infection. No
serious adverse event was noted throughout the study. Sub-
jective evaluation of tolerance by practitioners in the 46
patients who actually used the device was assessed as ex-
cellent in 14 cases, good in 10 cases, average in 11 cases,
and bad in 6 cases. Acceptability of the device is presented
in Table 6. Interestingly, most patients noted that the device
was easy to remove, whatever the period of use.
Discussion
SUI is a major public health issue in community-dwelling
women [2]. Several treatment options are available, from
behavioral therapy to surgery, but enhancement of public
and professional education is needed to overcome patient
embarrassment and improve practitioner knowledge about
this disease [6]. Continence intravaginal devices and
pessaries are good examples of such unknown aspects of
the disease and its management. Indeed, although some
devices have been shown to be efficient, they are barely
proposed by practitioners, because of a lack of information
and also of patientsreluctance to use them [11].
In the current study, the new 75NC007 intravaginal device
was effective in decreasing the number of episodes of SUI. It
was also safe and well accepted by patients. These results may
overcome the limitations of previously reported work and
advocate for a better consideration of intravaginal devices.
Indeed, few studies of disposable intravaginal devices [18]
are designed as randomized controlled trials [15]. Accordingly,
the level of evidence supporting the use of these devices is
lower than for other options [7,15,19]. By contrast, the current
study design ensured good quality data and gives its outcomes
a high level of evidence, free of methodological flaws.
Our positive results suggest that intravaginal devices are
able to improve symptoms. Indeed, the use of the 75NC007
device led to a significant reduction of the number of incon-
tinence episodes per week, as compared to the control
group. This is of critical importance since recent reports
showed that reduction of IEF has a major impact on clinical
condition [20]. Yalcin et al. have assessed the link between
reduction of IEF (stratified by deciles) and improvement of
quality of life in women enrolled in trials evaluating dulox-
etine for SUI management. Reduction of at least 75 % of
incontinence episodes was associated with straight and sig-
nificant improvement of clinical condition in these patients.
In the current study, the mean reduction of IEF was 31 % in
Table 2 Deviations from the
protocol during follow-up
WIC written informed consent
Number Control group Treatment group
1 No data in bladder diary. Has withdrawn from the study
because of insufficient device effectiveness
2 No data in bladder diary. Personal
decision to withdraw from study
3 No data in bladder diary. Has withdrawn from the study
because of insufficient device effectiveness
4 Lost to follow-up. No data in bladder diary
5 No data in bladder diary
6 Has withdrawn from the study because device did not
stay in place
7 Device not used at all
8 Withdrawal of WIC
9 Device used during only 5 days
10 No data in bladder diary. Has withdrawn from the study
because of insufficient device effectiveness
11 No data in bladder diary. Personal
decision to withdraw WIC
12 Lost to follow-up
13 No data in bladder diary. Lost to follow-up
14 No data in bladder diary. Has withdrawn from the study
because device uncomfortable to wear
Int Urogynecol J
the ITT population, and the median reduction almost 52 %,
with one patient reporting no leakage at all and four patients
having a negative pad test when treated. These data are thus
in favor of meaningful improvement of clinical condition
with the use of the 75NC007 device, even though the study
by Yalcin et al. did not strictly apply to the evaluation of
Randomized (n=55)
Untreated (n=26) Treatment by 75NC007(n=29)
Major outcome non
evaluable (n=2)
Use of the device less
than 6 hours a day (n=9)
Major outcome non
evaluable (n=3)
Analysed (n=24) Analysed (n=17)
Full analysis set (FAS) : 41 patients
Assigned for eligibility (n=68)
Excluded (n=13)
Incontinence episodes <8 (n=6)
Active urinary infection (n=1)
Lost to follow-up (n=5)
Modification of physical activity (n=1)
Enrollment
Fig. 3 Flowchart of the study
Table 3 Patient characteristics
SUI stress urinary incontinence,
USP Urinary Symptom Profile,
OAB overactive bladder
a
Mean ± SD (range)
b
n(%)
Variable Untreated (n026) Treated (n029) p
Age
a
60.6± 13.1 (3688.0) 56.8± 13.8 (2985) 0.30
Pregnancies
a
2.1± 1.6 (08) 2.4± 1.5 (06) 0.48
Vaginal deliveries
a
1.8± 1.3 (06) 1.5± 1.3 (05) 0.52
Body mass index
a
26.5± 5.0 (19.938.8) 26.1± 4.1 (20.236.0) 0.93
Postmenopausal
a
19 (73.08) 19 (65.52) 0.54
24-h pad test
a
78.2± 102.5 (4394) 41.7± 59.6 (0268) 0.06
Leakage episodes on 14-day diary
a
57.4± 64.8 (8234) 35.4± 35.4 (9174) 0.18
History of pelvic floor muscle training
b
22 (84.62) 22 (75.86) 0.42
Previous surgery for SUI
b
5 (71.43) 3 (42.86) 0.51
Hysterectomy
b
6 (42.86) 2 (10.53) 0.04
Pad usage
b
20 (76.92) 27 (93.10) 0.13
USP questionnaire
SUI subscore (/9) 5.6± 2.7 (09) 6.2± 2.0 (29) 0.47
OAB subscore (/21) 10.3± 3.6 (517) 8.3± 3.5 (016) 0.04
Dysuria subscore (/10) 0.8± 1.3 (04) 1.2± 1.7 (08) 0.44
Int Urogynecol J
medical devices. These results favorably compare with other
studies evaluating intravaginal devices [1012,18,21,22].
The pad test showed a slight reduction in the treated
group, without reaching statistical significance. This needs
further confirmation as the primary endpoint of the study
was the number of incontinence episodes, on which our
sample size calculation was based. One possible explanation
for the pad test results could be that the device plays its role
by avoiding sudden urinary leakage episodes, but not com-
pletely suppressing the involuntary loss of urine. Then the
perceived number of incontinence episodes is lower, but
some urine, continuously and slowly dribbling, can second-
arily wet the pad.
In the current study, 14 of 55 patients dropped out (2
patients in the control group and 12 in the treatment group).
This is consistent with the fact that patients are often reluc-
tant to use intravaginal devices [11], even if they initially
overcome their doubts and signed informed consent. De-
spite this relatively high rate of dropout, the results were
significant in both PP and ITT analysis, with respect to
efficacy endpoints (Table 4). Differences between the treat-
ment and control groups were more important in the PP than
in the ITT analysis. The differences observed between the
mean values of the parameters studied (Table 4) in the ITT
and PP groups were related to the presence of three outliers
in the ITT population and to the nonparametric distribution
of the variables. Hence, the current device is effective in the
real lifeclinical setting, and efficacy is obviously in-
creased in patients with optimal adherence to the treatment,
consistent with the results obtained in randomized con-
trolled trials about drug therapy [23].
The comfort of use and acceptability of the device was
very good, as assessed by patients who actually wore the
device during the entire study. Vaginal irritation, pain, and
discomfort have been reported with devices supporting the
bladder neck [12], whereas in the current study, the only
adverse events were one case of metrorrhagia and one of
urinary tract infection. Regarding the daily use, the applica-
tor was less frequently needed in patients who wore the
device for 28 days as compared to those who wore it only
Table 5 Variation of items of
CONTILIFE score in the two
parallel groups
Data are given as mean ± SD
(range)
CONTILIFE items Variation of each score between day 14 and day 28 p
Control group (n024) Treatment group (n022)
Daily activities 0.4± 3.7 (7 to +7) 2.8±6.6 (15 to +8) 0.20
Effort 0.7± 2.3 (4 to +5) 3.2±5.3 (13 to +5) 0.22
Self-image +0.3±5.2 (12 to +10) 3.5±6.4 (18 to +6) 0.09
Emotional consequences 0.2 ± 3.9 (9 to +6) 3.1± 5.3 (14 to +7) 0.04
Sexuality 0.1± 1.0 (3 to +2) 0.9±2.7 (9 to +3) 0.30
Overall quality of life +0.04± 1.0 (3 to +2) +0.82± 1.3 (1 to +4) 0.05
Total score 2.4± 11.3 (25 to +22) 12.7± 22.6 (56 to +22) 0.23
Table 4 Results of primary and secondary outcomes obtained from intent-to-treat and per-protocol analysis
Per-protocol analysis Intent-to-treat analysis
Control group
(n024)
Treatment group
(n017)
pControl group
(n026)
Treatment group
(n029)
p
Relative variation of IEF 8.25 ± 25.4 %
(67 to +35)
68.8± 22 %
(100 to 28)
<0.0001 7.6±24.5 %
(67 to +35)
31.7± 65.1 %
(100 to +155)
0.0023
Variation of SUI subscore of
USP
0.21± 2.3
(7 to +4)
3 ±2.3
(7 to +1)
0.0015 0.2±2.3
(7 to +4)
2.4± 2.5
(7 to +3)
0.0043
Variation of OAB subscore of
USP
0.2± 1.8
(3 to +3)
1.5± 2.4
(4 to +4)
0.021 +0.21± 1.82
(3 to +3)
1.46± 2.38
(7 to +5)
0.016
Variation of dysuria subscore of
USP
0.12± 0.78
(2to +2)
0.29± 0.81
(1 to +3)
0.087 +0.3±0.8
(1 to +3)
0.2± 0.8
(2 to +2)
0.043
Pad test relative variation +41.3± 166 %
(100 to +650)
12.8± 128 %
(100 to +340)
0.094 +41.3 ± 166 %
(100 to 650)
+8.4± 116 %
(100 to 340)
0.4
Patient satisfaction
(0 to 100 visual analogue scale)
5±18
(072)
78± 27
(2100)
<0.0001 5± 18
(072)
59.9± 39.4
(0100)
0.0003
All data are given as mean ± SD (range)
IEF incontinence episode frequency, SUI stress urinary incontinence, OAB overactive bladder, USP Urinary Symptom Profile
Int Urogynecol J
for 14 days, suggesting that patients rapidly acquired the most
convenient way to introduce the device. This is in line with the
high numbers of favorable patient opinions in our study about
the ease of insertion/removal. The user-friendliness of the
75NC007 device may be related to its thin form, elasticity,
and the availability of two different sizes. Patient complaints
about the device were limited to the slipperiness of the device
(four cases of spontaneous loss) and bothersome sensation
during use (three cases). Sexuality, where relevant, was not
impacted by the presence of the device. Up to half of the
participants declared that they were interested in using the
device, in line with previous reports [12,24]. However, it must
be kept in mind that one patient withdrew from the study
because the device did not stay in place, and some others
stopped using the device because they found it uncomfortable
to wear or its effectiveness insufficient. These results suggest
that intravaginal devices cannot fit every patient because of
basic reluctance or disappointment and that practitioners have
an important role regarding patient education.
The current study has several limitations. Whether or not the
device is effective and well tolerated in the long term requires
further confirmation, as the treatment period was only 1 month.
However, as previously published in extensive reviews, most
noninvasive treatments of urinary incontinence are poorly eval-
uatedinthelongterm[15,18]. The small sample size of the
current study was sufficient to reach the power to detect a
difference in the primary endpoint but may lack power to draw
conclusions about secondary endpoints, e.g., the pad test and
the CONTILIFE variation, both endpoints showing a trend
towards an improvement in the treatment group without reach-
ing statistical significance. Finally, the current study was a pilot
study which did not compare the 75NC007 device with other
existing mechanical intravaginal devices. Such a comparison
would have been very informative and deserves a further
randomized controlled trial, using a noninferiority study design.
Acknowledgments The authors thank B.BRAUN Medical SAS for
their funding support.
The authors thank the other 75NC001 Study Group investigators
who participated in the conduct of the trial included the following: O.
Chevallier, MD, Paris, France; P. Grise, MD, Rouen, France; JF
Hermieu, MD, Paris, France; C Jouffroy, MD, Metz, France; L.
Lenormand, MD, Nantes, France; C Marhic, MD, Vincennes, France;
T Mouchel, MD, Le Mans, France; JL Pouch, MD, Paris, France.
Conflicts of interest Professor Stephane Mouly received consultan-
cy honoraria from B. Braun, Pfizer, Sanofi-Aventis, Lilly Research
Laboratories, Lundbeck and Chugai Pharma. Other authors have no
conflicts of interest to declare.
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Table 6 Results of evaluation of acceptability of the device in popu-
lation exposed
14 days of
treatment
28 days of
treatment
Total p
Number of patients 24 22 46
Use of applicator 20 10 30 0.03
Ease of use
Excellent 10 3 13 0.65
Good 8 5 13
Average 0 0 0
Bad 2 2 4
Comfort
Excellent 6 2 8 0.93
Good 10 6 16
Average 3 1 4
Bad 1 1 2
User-friendliness
Excellent 3 5 8 0.08
Good 14 4 18
Average 5 7 12
Bad 1 2 3
Ease of insertion
Excellent 6 7 13 0.14
Good 13 5 18
Average 3 6 9
Bad 1 0 1
Ease of removal
Excellent 13 14 27 0.32
Good 8 4 12
Average 2 0 2
Bad 0 0 0
Sexual activity
Presence 11 8 19 0.83
Pain or discomfort 0 1 1 0.42
Interest in buying the device
Very interested 3 2 5 1
Interested 5 5 10
Little interested 6 4 10
Not interested 8 7 15
Int Urogynecol J
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Int Urogynecol J
... This may imply that the IncoStress device is effective; however a larger sample and statistical analysis are required to confirm it. Similar findings were also demonstrated in another RCT, published by Cornu et al. in 2012 [12]. They reported that the 75NC007 intravaginal device was effective in decreasing the number of episodes of SUI in 29 patients and improving the global score of quality of life. ...
... In our study, most of the patients used the device during the day, finding it acceptable, and overall easy to use and of those who used it most were satisfied. Equally, Cornu et al. reported that the 75NC007 intravaginal device was found to be easy to use (26 out of 46) and acceptable by most of the patients (38 out of 46), although women were not asked about satisfaction with the device [12]. In our study, some patients used the device mainly at night because it did not stay in place whilst doing any activities and some found it uncomfortable. ...
... Research on mechanical devices for UI is limited, although studies that are available do show some positive results [12,13,15,16]. Although devices present a potentially cheap intervention and give immediate relief of symptoms, they are not widely used because the evidence is not available on clinical or cost effectiveness or for whom and under what circumstances they may be most beneficial. ...
Article
Full-text available
Introduction and hypothesis The aim of this study was to assess the feasibility of recruitment to and outcomes from a pilot randomised study of the IncoStress device as an adjunct to conservative treatment for urinary incontinence. Methods Women with urinary incontinence were randomised on a 2:1 basis to usual care (control) or usual care plus use of the IncoStress device (intervention). Process outcomes (retention and compliance) were recorded plus symptom outcomes (IQOL and ICIQ-FLUTS questionnaires). A sample of participants took part in an interview to understand the frequency of use of the device and satisfaction. Results Eighty women (51 intervention, 29 control) were recruited. Follow-up responses were obtained from 34 intervention group (66.7%) and 17 (58.6%) control patients. Women used the device for a median 3 days a week (0–7), 18 out of 34 (53%) found it easy to use and 21 (61.8%) were satisfied with the device. Median IQOL score in the intervention group improved from a baseline of 42.4 (0–94) to 68.2 (5–98) at follow-up and in the control group from 45.5 (0–88) to 53.0 (0–94). Median ICIQ-FLUTS score in the intervention group improved from 14.5 (6–35) to 12.5 (4–26) and in the control group from 15.0 (5–35) to 14.0 (6–38). Conclusions Recruitment and randomisation were feasible and robust. This study demonstrates that a large-scale RCT is feasible and the IncoStress has potential value.
... The literature search in Lipp et al 12 included four RCTs (published as five studies) ( Table 2). [27][28][29][30][31] We excluded one study 30 from our analysis since it only reported data for an outcome (24-hour pad test) that is not included in our analysis. We did not identify any studies other than the Lipp et al review. ...
... One randomized controlled trial (RCT) reported on improvement of symptoms for pessaries compared with no treatment 27 and one RCT presented results for pessaries compared with pelvic floor muscle training (PFMT) ( Table 3). 29,31 For pessary compared with no treatment, there was no significant difference in the number of incontinence episodes per week, over a follow-up period of 2 weeks (mean difference [MD] = −24.10, ...
... 95% confidence interval [CI] −49.60 to 1.40). 27 However, people with pessaries had significantly improved subscores in the SUI category (MD = −2.20, 95% CI −3.47 to −0.93) as well as the dysuria category (MD = −0.50, ...
... Conceptualized as such, the device was tested by a multicentric randomized trial [11] with the aim of establishing whether it is highly efficacious in regard to stress urinary incontinence, as well as in regard to mixed incontinence urges, the absence of dysuria, ...
... This new therapeutic tool is effective, is self-managed by the patients, and no significant secondary effects were noted [11]. Thus, it is well suited to complement currently available treatments (e.g. ...
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An intravaginal device to prevent urinary incontinence was devised based on the notions of the ‘viscoelasticity of the anterior vaginal’ wall. As the anterior vaginal wall can be divided into segments with differing viscoelastic properties, this device is comprised of two parts: a rigid component to treat the urethral side, and a flexible ring-shaped component to exploit thee lastic properties of the anterior vaginal wall in its horizontal portion under the bladder. The resulting device has the potential to address each stage of bladder function in women: straining, bladder filling, and micturition. These specifications ensure that the device is effective and well tolerated by patients. This is hence a new therapeutic approach for the managementof female urinary incontinence. The high efficiency of the device is a validation of the physiological notion of differential viscoelastic properties of the pelvis (and the anterior vaginal wall) on either side of the vaginal cap.
... in recent years an intravaginal device (Diveen ® ), to reduce the risk of urine loss, has been made available and successfully tested in a French population. 4 Testing the effectiveness and tolerability of Diveen ® in reducing urinary leakage in a population of italian women, equally distributed throughout the country. ...
Article
Full-text available
Background: Urinary incontinence significantly affects daily life of suffering women. Minimally invasive solutions to cope with urine leakage would be of great interest. Methods: A survey to investigate efficacy and compliance of an innovative intravaginal device (Diveen<sup>®</sup>) to reduce the risk of urine leakage was performed in 5 Urogynecological Centers across Italy. Women with urodynamic diagnosis of stress incontinence, included mixed conditions, underwent the survey. Results: The device was effective (60%) independently from severity of Incontinence or the presence of concomitant detrusor overactivity (mixed forms) with a positive impact on quality of life in more than half of the women. Also compliance with the device was satisfactory (up to 73%). Clinically symptomatic prolapse and age >65 years are the only limiting factors in terms of efficacy and compliance, while the menopausal status would not seem to affect these aspects. Conclusions: Despite global satisfactory outcomes, 46% of the surveyed women declare their propensity to use the device. This data deserves further investigation.
... We found a single prospective randomized parallelgroup trial from 2012 that compared the effectiveness of 2 weeks' treatment with an intravaginal tampon device against no treatment for women with stress UI (n = 55), using the Urinary Symptom Profile questionnaire. 16 The authors found a greater decrease in the primary outcome, incontinence episode frequency, in the treated group (mean −31.7%) than in the control group (mean −7.6%) in the intention-to-treat analysis (P = .0023). Mean symptom scores also decreased to a greater degree in the treated group compared with the untreated group for stress UI (P = .0043), ...
Article
Full-text available
Aims: An increasing number of diagnostic and therapeutic medical devices are available to help patients and physicians manage pelvic floor symptoms in women. Many of these are presented at scientific conferences, and in the absence of a gold standard for evaluation, marketing has become more prominent than scientific evaluation. The goal of this study was to (a) provide an overview of pelvic floor devices for women that have been presented at recent annual meetings of leading scientific societies and (b) to summarize and review the scientific evidence underpinning these devices. Methods: Manual searches were performed of all abstracts presented in 2016 and 2017 at annual meetings of the International Continence Society, the International Urogynecological Association, the European Association of Urology, and the American Urological Association. The exhibition floor of the 2017 International Continence Society was also searched. Subsequently, literature searches of both the MEDLINE and Embase databases were performed in November 2018 to identify original full-text publications related to the identified devices. Results: We identified 11 devices from these sources, which were mainly used for the control of urinary incontinence. Only seven of these pelvic floor devices were covered by publications, with no full-text records identified for the remaining four devices. Conclusions: Sample sizes were small and there was a lack of convincing evidence for most devices. Despite this, many devices were available in the market. Our findings indicate that the process for introducing these new devices is in stark contrast with the strict requirements for introducing new drug classes.
... This issue was raised by the results of the multicentric study [20] evaluating the efficacy of the Diveen intravaginal device for treating stress urinary incontinence, with the aim of verifying the hypothesis that there is a physiological difference in vaginal and pelvic elasticity on each side of the vaginal cap [21,22]. This clinical evaluation by a multicentric group involved doctors who were engaged in different health sectors (e.g. ...
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An analysis of the literature has allowed for a redefinition of the anatomy of the ilio-coccygeus muscle (ICM) its insertions and its trajectory, the direction of its fibers and its relation to the base of the bladder. Static MRI studies have revealed its V-shaped appearance, while dynamic MRI has been used to visualize its concave contraction into a dome-shape that provides support to the levator plate, raising the base of the bladder. Histological studies have shown that the percentage of type I muscle fibers is 66% to 69%, which is comparable to the type I fiber content of the pubovisceral muscle (PVM), thus reflecting both its postural role as well as functions based on frequent voluntary contractions. Together, these data suggest an active role for the ICM which, upon urination, allows for voluntary hardening of the levator plate. The abdominal pressure from bearing down hence enables urinary draining by compressing the bladder on a hard surface. The physiological function of the ICM is therefore not only postural, but also to enable urination. From a therapeutic perspective, a multicentric study has shown that, by reinforcing the action of the ICM, use of a Diveen intrauterine device improved dysuria.
... This issue was raised by the results of the multicentric study [20] evaluating the efficacy of the Diveen intravaginal device for treating stress urinary incontinence, with the aim of verifying the hypothesis that there is a physiological difference in vaginal and pelvic elasticity on each side of the vaginal cap [21,22]. This clinical evaluation by a multicentric group involved doctors who were engaged in different health sectors (e.g. ...
Article
Full-text available
An analysis of the literature has allowed for a redefinition of the anatomy of the ilio-coccygeus muscle (ICM) its insertions and its trajectory, the direction of its fibers and its relation to the base of the bladder. Static MRI studies have revealed its V-shaped appearance, while dynamic MRI has been used to visualize its concave contraction into a dome-shape that provides support to the levator plate, raising the base of the bladder. Histological studies have shown that the percentage of type I muscle fibers is 66% to 69%, which is comparable to the type I fiber content of the pubovisceral muscle (PVM), thus reflecting both its postural role as well as functions based on frequent voluntary contractions. Together, these data suggest an active role for the ICM which, upon urination, allows for voluntary hardening of the levator plate. The abdominal pressure from bearing down hence enables urinary draining by compressing the bladder on a hard surface. The physiological function of the ICM is therefore not only postural, but also to enable urination. From a therapeutic perspective, a multicentric study has shown that, by reinforcing the action of the ICM, use of a Diveen intrauterine device improved dysuria.
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Full-text available
A multicenter, randomized, controlled clinical trial and four postmarket user acceptance investigations were carried out to document the safety, performance, and user acceptance of Efemia Bladder Support, a novel vaginal inlay for the temporary reduction of stress urinary incontinence (SUI). The clinical investigation enrolled 97 women diagnosed with SUI, randomized 3 : 1 to either treatment or standard care (control). The primary endpoint was reduction of urine leakage, measured as change in pad weight baseline week compared with treatment week. Secondary endpoints were treatment success, calculated as the percentage of subjects with >70% reduction in pad weight, reduction in incontinence episodes, and quality of life (QoL). 75 women (77%) completed the clinical investigation. No serious adverse events occurred. The treatment group reached a 55% (p < 0.001) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% (p < 0.001) mean reduction of leakage. No significant effect on QoL could be observed. 51% of the women answered "yes" to the question if they would use the device to reduce SUI. The user acceptance of the device was further investigated in four postmarket studies, using an improved device design with a slimmer centerpiece and a thinner handle, while keeping the effect achieving parts of the device unchanged. An average of 74% of the 102 participants in the postmarket studies reported that they were likely to continue using Efemia. The highest user satisfaction was seen in the two studies evaluating the use of Efemia during exercise, where 83% and 88% of the women were likely to continue using Efemia. It can be concluded that Efemia is a safe, well-tolerated, and effective alternative for reducing SUI, both in everyday life and during physical exercise.
Article
Full-text available
Background Urinary incontinence (UI) is a common malady in women. Numerous nonsurgical treatments are available, each associated with risk of adverse events (AEs). Methods We systematically reviewed nonsurgical interventions for urgency, stress, or mixed UI in women, focusing on AEs. We searched MEDLINE®, Cochrane Central Trials Registry, Cochrane Database of Systematic Reviews, and Embase® through December 4, 2017. We included comparative studies and single-group studies with at least 50 women. Abstracts were screened independently in duplicate. One researcher extracted study characteristics and results with verification by another independent researcher. When at least four studies of a given intervention reported the same AE, we conducted random effects model meta-analyses of proportions. We also assessed the strength of evidence. Results There is low strength of evidence that AEs are rare with behavioral therapies and neuromodulation, and that periurethral bulking agents may result in erosion and increase the risk of voiding dysfunction. High strength of evidence finds that anticholinergics and alpha agonists are associated with high rates of dry mouth and constitutional effects such as fatigue and gastrointestinal complaints. Onabotulinum toxin A (BTX) is also associated with increased risk of urinary tract infections (UTIs) and voiding dysfunction (moderate strength of evidence). Discussion Behavioral therapies and neuromodulation have low risk of AEs. Anticholinergics and alpha agonists have high rates of dry mouth and constitutional effects. BTX is associated with UTIs and voiding dysfunction. Periurethral bulking agents are associated with erosion and voiding dysfunction. These AEs should be considered when selecting appropriate UI treatment options. AE reporting is inconsistent and AE rates across studies tended to vary widely. Trials should report AEs more consistently.
Article
Full-text available
Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)
Article
Objective: To review the available evidence concerning the fitting, management, and efficacy of pessaries used to treat stress incontinence.To describe a method of fitting and managing incontinence pessaries.
Chapter
https://www.ics.org/Publications/ICI_4/book.pdf
Article
Background: Urinary incontinence in women is a common problem that adversely affects quality of life. Purpose: To synthesize evidence of management of urinary incontinence in women. Data sources: MEDLINE, CINAHL, and the Cochrane Library. Study selection: 96 randomized, controlled trials (RCTs) and 3 systematic reviews published in English from 1990 through May 2007. Data extraction: Using standardized protocols, reviewers abstracted cases of continence, improvement of urinary incontinence, and prevalence of urinary incontinence to calculate risk difference. Data synthesis: Compared with regular care, pelvic floor muscle training plus bladder training resolved urinary incontinence (pooled risk difference, 0.13 [95% CI, 0.07 to 0.20]). Pelvic floor muscle training alone resolved or improved urinary incontinence compared with regular care, although the effect size was inconsistent across studies. Different injectable bulking agents and medical devices were associated with similar continence and improvement rates. Electrical stimulation failed to resolve urinary incontinence. Oral hormone administration increased rates of urinary incontinence compared with placebo in most RCTs (1243 women). Transdermal or vaginal estrogen resulted in inconsistent improvement of urinary incontinence. Adrenergic drugs did not resolve or improve urinary incontinence. Oxybutynin or tolterodine resolved urinary incontinence compared with placebo (pooled risk difference, 0.18 [CI, 0.13 to 0.22]). Duloxetine compared with placebo improved (pooled risk difference, 0.11 [CI, 0.07 to 0.14]) but did not resolve urinary incontinence, with no significant dose-response association. Limitations: Inconsistent measurements of outcomes limited the findings. Predictors of better effect have not been identified in RCTs. Conclusion: Moderate levels of evidence suggest that pelvic floor muscle training and bladder training resolved urinary incontinence in women. Anticholinergic drugs resolved urinary incontinence, with similar effects from oxybutynin or tolterodine. Duloxetine improved but did not resolve urinary incontinence. The effects of electrostimulation, medical devices, injectable bulking agents, and local estrogen therapy were inconsistent.
Article
Background: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management, particularly when a woman does not want surgery or when she is considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. Objectives: To determine whether mechanical devices are useful in the management of adult female urinary incontinence. Search methods: For this second update we searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 21 August 2014), EMBASE (January 1947 to 2014 Week 34), CINAHL (January 1982 to 25 August 2014), and the reference lists of relevant articles. Selection criteria: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined by symptom, sign or urodynamic diagnosis. Data collection and analysis: The reviewers assessed the identified studies for eligibility and risk of bias and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 5.3). Main results: One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure. Authors' conclusions: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.
Article
This article examines the issues of stress urinary incontinence (SUI) in women and a new treatment option now available; FemSoft, an intraurethral insert. SUI is the most common type of urinary incontinence in women. There are many causes, risks and predisposing factors that nurses need to be aware of, both in treating the complaint and preventing future episodes. As incontinence causes a high level of embarrassment, patients are reluctant to seek help, so when the patient presents, nurses need to be able to provide accurate information on all treatments available. A brief description will be given of other management options, but the main focus will be on FemSoft, describing its features, benefits and research evidence so far.
Article
Urinary incontinence is a common geriatric syndrome that affects at least 1 in 3 older women and can greatly diminish quality of life. Incontinence has been associated with increased social isolation, falls, fractures, and admission to long-term care facilities. Often unreported and thus untreated, it is important to include incontinence as part of the review of systems for all older women. Using the case of Mrs F, we highlight the chronicity of incontinence and discuss the evidence base for evaluation of incontinence in older women, with proper initial diagnosis of the type of incontinence-stress, urgency, or mixed-in order to prescribe optimal treatment. We present an evidence-based discussion of available incontinence treatments including pelvic floor muscle exercises, stress strategies, urge-suppression strategies, fluid management, medications, intravaginal pessaries, intravesical injection of botulinum toxin, percutaneous tibial nerve stimulation, sacral neuromodulation, and surgical procedures for stress incontinence. Special considerations in evaluation and treatment of patients with dementia are presented. Urinary incontinence treatments yield high levels of patient satisfaction and improvements in quality of life.