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

NCT ID: NCT02131311

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-09-30

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.

Conditions

Stress Urinary Incontinence (SUI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pessary

disposable, single-use pessary

Group Type: EXPERIMENTAL

disposable, single-use pessary

Intervention Type: DEVICE

Interventions

disposable, single-use pessary

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall Severance, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research, Inc.

Locations

Study Center

Chandler, Arizona, United States

Countries

United States

Other Identifiers

2012118

Identifier Type: -

Identifier Source: org_study_id