Dataset Information

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

ABSTRACT:

Objective

The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.

Methods

A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.

Results

Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.

Conclusions

The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.

SUBMITTER: Duenas-Garcia OF

PROVIDER: S-EPMC7720247 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

Duenas-Garcia Omar Felipe OF Shapiro Robert Edward RE Gaccione Peter P

Female pelvic medicine & reconstructive surgery 20210601 6

<h4>Objective</h4>The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.<h4>Methods</h4>A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the ...[more]

PMID: 32453209

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Project description:We evaluated a novel disposable, collapsible, ring-shaped vaginal device that is self-inserted within an applicator and removed with a string. The device was developed to overcome the drawbacks of existing ring pessaries for non-surgical pelvic organ prolapse management (POP). The primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires. A total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection. The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic. Clinical. gov , NCT02239133 , posted September 12, 2014 (retrospectively registered).

Project description:BackgroundIn 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.ResultsThe sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880).ConclusionOur small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices.Trial registrationClinicalTrials.gov NCT00685217, 22 May 2008.

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Dataset Information

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

Objective

Methods

Results

Conclusions

Publications

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

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