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

NCT02131311 | Completed Results

• 1 other identifier: 2012118
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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)

Keywords

single use; disposable; pessary; stress urinary incontinence; sui

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders for Pad Weight Gain or SUI Episodes

  from the 14-day baseline period to the last 7 days of 14-day device usage period

Secondary Outcomes (6)

• Change in Stress Urinary Incontinence Episodes

  from the 14-day baseline period to the last 7 days of 14-day device usage period

• Change in Pad Weight Gain

  from the 14-day baseline period to the last 7 days of 14-day device usage period

• Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)

  baseline and end-of-treatment

• Change in Stress Urinary Incontinence Episodes

  from the 14-day baseline period to the first 7 days of 14-day device usage period

• Change in Pad Weight Gain

  from the 14-day baseline period to the first 7 days of a 14-day device usage period

Study Arms (1)

pessary

EXPERIMENTAL

disposable, single-use pessary

Device: disposable, single-use pessary

Interventions

disposable, single-use pessary DEVICE

pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Study Center

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mylissa Trowbridge
• Organization: Procter & Gamble Company Global Clinical Sciences

trowbridge.mm@pg.com

Study Officials

• Randall Severance, MD

  Radiant Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 24, 2016
• Results First Posted: March 24, 2016

Record last verified: 2016-02

Locations

US (1)