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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Absorbent pad; Device: pessary

• Registration Number: NCT02160314
• Lead Sponsor: Procter and Gamble

Brief Summary

This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-01
• Results First Submitted: 2016-01-15
• Results First Submitted QC: 2016-01-15
• Last Update Submitted: 2016-01-15
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• be female 18 years or older;
• provide written informed consent prior to study participation and been given a signed copy;
• be in generally good health as determined by the Investigator;
• have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (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

• are 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 and could impact the safety of the subject or the outcome of the study; or
• for any reason, the Investigator decides that the subject should not participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pad	Absorbent pad	absorbent pad control
pessary	pessary	disposable, single-use pessary

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Serious Adverse Event	3 month	proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event

Trial Locations

Locations (1)

Study Center; 🇺🇸 Chandler, Arizona, United States