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

• ClinicalTrials.gov Identifier: NCT01762345
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Results First Posted: March 24, 2016
• Last Update Posted: March 24, 2016
• Sponsor: Procter and Gamble
• Information provided by (Responsible Party): Procter and Gamble

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Device: pessary (disposable intra-vaginal device)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 148 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
• Study Start Date: December 2012
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: pessary device; pessary (disposable intra-vaginal device)	Device: pessary (disposable intra-vaginal device); pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble

Outcome Measures

Primary Outcome Measures :

1. Change in Pad Weight Gain [ Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period ]
   Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
2. Change in Stress Urinary Incontinence Episodes [ Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period ]
   Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Secondary Outcome Measures :

1. Change in Pad Weight Gain [ Time Frame: from the 14-day baseline period to the first 7 days of 14-day device usage period ]
   Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
2. Change in Stress Urinary Incontinence Episodes [ Time Frame: from the 14-day baseline period to the first 7 days of 14-day device usage period ]
   Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
3. Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: baseline and end-of-treatment ]
   The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.

Other Outcome Measures:

1. Percentage of Responders for Pad Weight Gain [ Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period ]
2. Percentage of Responders for SUI Episodes [ Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Study Center

Chandler, Arizona, United States, 85224

Sponsors and Collaborators

Procter and Gamble

Investigators

• Principal Investigator: Randall Severance, MD; Radiant Research, Inc.

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT01762345
• Other Study ID Numbers: 2012099
• First Posted: January 7, 2013
• Results First Posted: March 24, 2016
• Last Update Posted: March 24, 2016
• Last Verified: February 2016

Keywords provided by Procter and Gamble:

Stress urinary incontinence; SUI

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders