A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: pessary (disposable intra-vaginal device)

• Registration Number: NCT01762345
• Lead Sponsor: Procter and Gamble

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2016-01-15
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Results First Posted: 2016-03-24
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pessary device	pessary (disposable intra-vaginal device)	pessary (disposable intra-vaginal device)

Primary Outcome Measures

Name	Time	Method
Change in Pad Weight Gain	from the 14-day baseline period to the last 7 days of 14-day device usage period	Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Change in Stress Urinary Incontinence Episodes	from the 14-day baseline period to the last 7 days of 14-day device usage period	Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Pad Weight Gain	from the 14-day baseline period to the first 7 days of 14-day device usage period	Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Change in Stress Urinary Incontinence Episodes	from the 14-day baseline period to the first 7 days of 14-day device usage period	Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)	baseline and end-of-treatment	The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.

Trial Locations

Locations (1)

Study Center; 🇺🇸 Chandler, Arizona, United States