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

Procter & Gamble (P&G)

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: pessary

Device: Absorbent pad

Study type

Interventional

Funder types

Industry

Identifiers

NCT02160314

2012119

Details and patient eligibility

About

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.

Enrollment

224 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.