Trial reportInternational urogynecology journal2012
75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial.
Trial report in International urogynecology journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews.The Cochrane database of systematic reviews · 2022Pooled it
- Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.Ontario health technology assessment series · 2021Pooled it
- Adverse Events Associated with Nonsurgical Treatments for Urinary Incontinence in Women: a Systematic Review.Journal of general internal medicine · 2019Pooled it
- Mechanical devices for urinary incontinence in women.The Cochrane database of systematic reviews · 2014Pooled it
- Evaluation of the IncoStress device for urinary incontinence: a feasibility study and pilot randomised controlled trial.International urogynecology journal · 2019Trial
- Relationship Between A Body Shape Index and Self-Reported Stress Urinary Incontinence Among US Women: A Cross-Sectional Analysis.International urogynecology journal · 2025Article
- A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies.Advances in urology · 2021Article
- Scientific evidence for pelvic floor devices presented at conferences: An overview.Neurourology and urodynamics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisManagement 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.
methodsA 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.
resultsFifty-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.
conclusionsThe 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.