N/A
Completed N=83
A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
Source: ClinicalTrials.gov NCT01762345 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Change in Pad Weight Gain — 2.67 grams/usage period
Summary
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pad Weight Gain |
2.36 | — |
| PRIMARY Change in Stress Urinary Incontinence Episodes |
0.65 | — |
| SECONDARY Change in Pad Weight Gain |
2.36 | — |
| SECONDARY Change in Stress Urinary Incontinence Episodes |
0.65 | — |
| SECONDARY Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) |
9.52 | — |
Eligibility Criteria
Inclusion Criteria
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence
- be willing to use the pessary investigational device to control stress incontinence
Exclusion Criteria
- pregnant, lactating or planning to become pregnant during the study
- within 3 months post partum
- intrauterine device (IUD) placement of less than 6 months
- a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
- experience difficulty inserting or wearing an intra-vaginal device, including a tampon
- vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months
- has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator
- for any reason, the Investigator decides that the subject should not participate in the study
Data sourced from ClinicalTrials.gov (NCT01762345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.