At a glance
ClinicalIndex Comparison RecordN/ACompleted· 145 enrolled
Drug / intervention
disposable, single-use pessarydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
In Brief
A clinical study evaluating disposable, single-use pessary for Stress Urinary Incontinence (SUI). Completed, enrolled 145 participants across 1 site.
Detailed Summary
This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence (SUI)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedMay 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedMay 6, 2014
Enrollment StartApr 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.2 years ago
Interventions
disposable, single-use pessarydevice