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Study Title and Description

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



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title 75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial.
Author Cornu JN., Mouly S., Amarenco G., Jacquetin B., Ciofu C., Haab F.
Country Department of Urology, Tenon Hospital, Assistance Publique-Hôpitaux de Paris, University Pierre-et-Marie-Curie Paris 6, 4 rue de chine, 75020 Paris, France. jeannicolas.cornu@gmail.com
Year 2012
Numbers Pubmed ID: 22588140

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 75NC007 intravaginal device
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2 untreated
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries France
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Funding source Industry funded/industry provided materials
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Inclusion criteria Age >= 18; SUI with at least 4 episodes/week or Mixed urinary incontinence with predominant SUI component; Postmenopausal or under contraception
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Exclusion criteria Vaginal delivery in the past 2 months, bladder or vaginal active disease, acute or recurrent urinary infection; pelvic organ prolapse; surgical intervention for SUI in the past 6 months; drug treatment for urinary incontinence in the last month; pelvic floor muscle training under way
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UI type
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100
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stress UI or mixed Ui with primary stress component
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Age 58.6
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mean
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13.6
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29, 88
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Men included 0
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Special populations 55
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100
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Race 55
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100
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Notes
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Did participants fail previous treatment? ... Some ... 14.5% previous UI surgery
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Study years 2006-2008
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Trial name (if given)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question 75NC007 intravaginal device untreated Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 29 26
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17 24
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12 2
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Use of the device less than 6 hours a day (n=9) Major outcome non evaluable (n=3) outcome could not be evaluated
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Notes No data entered.



Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB not reported
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis High RoB differential dropout, some for tx reasons. excluded in analysis
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB
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ALL.....Incomplete results data (attrition bias) High RoB differential dropout >20% in one arm
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.