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

Procter and Gamble148 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Stress Urinary Incontinence

Interventions

pessary (disposable intra-vaginal device)DEVICE

pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Study Center

Chandler, Arizona, United States

Outcomes

Primary Outcomes

Change in Pad Weight Gain

Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period

Change in Stress Urinary Incontinence Episodes

Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period

Secondary Outcomes

Change in Pad Weight Gain

Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period

Change in Stress Urinary Incontinence Episodes

Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period

Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)

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.

Data from ClinicalTrials.gov

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