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

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

NCT02131311•Procter and Gamble

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Study Center

Chandler, Arizona, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

March 24, 2016

Enrollment

145

ACTUAL participants

Conditions

Stress Urinary Incontinence (SUI)

Interventions

disposable, single-use pessary

DEVICE

Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

NCT06862648

Stress Urinary Incontinence (SUI)

View study

RECRUITING

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

NCT06933407

Urinary IncontinenceUrinary Incontinence, Stress+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery

Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment