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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: disposable, single-use pessary

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Study Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pessary; disposable, single-use pessary	Device: disposable, single-use pessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress Urinary Incontinence Episodes	change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.	from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Pad Weight Gain	change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.	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)	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.	baseline and end-of-treatment
Change in Stress Urinary Incontinence Episodes	change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.	from the 14-day baseline period to the first 7 days of 14-day device usage period
Change in Pad Weight Gain	change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.	from the 14-day baseline period to the first 7 days of a 14-day device usage period
Percentage of Responders for Pad Weight Gain or SUI Episodes		from the 14-day baseline period to the first 7 days of 14-day device usage period

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: Randall Severance, MD, Radiant Research, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: stress urinary incontinence; pessary; single use; disposable; sui
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2012118