A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

be female 18 years or older;
provide written informed consent prior to study participation and receive a signed copy;
be in generally good health as determined by the Investigator;
have a ≥ 3 month history of experiencing SUI (self reported);
be willing to use the pessary investigational device to control stress urinary incontinence;
be willing to comply with study requirements and instructions;

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;
has self-reported difficulty emptying her bladder;
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 which could impact the safety of the subject or the outcome of the study;
for any reason, the Investigator decides that the subject should not participate in the study.

Arm && Interventions

Group	Intervention	Description
pessary	disposable, single-use pessary	disposable, single-use pessary

Primary Outcome Measures

Name	Time	Method
Percentage of Responders for Pad Weight Gain or SUI Episodes	from the 14-day baseline period to the last 7 days of 14-day device usage period

Secondary Outcome Measures

Name	Time	Method
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.
Percentage of Responders for Pad Weight Gain or SUI Episodes	from the 14-day baseline period to the first 7 days of 14-day device usage period
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 Pad Weight Gain	from the 14-day baseline period to the first 7 days of a 14-day device usage period	change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.