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

Procter & Gamble (P&G)

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: pessary (disposable intra-vaginal device)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01762345

2012099

Details and patient eligibility

About

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).

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

pessary device

Experimental group

Description:

pessary (disposable intra-vaginal device)

Treatment:

Device: pessary (disposable intra-vaginal device)