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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT01762345
First received: December 12, 2012
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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 Intervention
Stress Urinary Incontinence
Device: pessary (disposable intra-vaginal device)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Change in Pad Weight Gain [ Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period ] [ Designated as safety issue: No ]
    Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

  • 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 ] [ Designated as safety issue: No ]
    Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.


Secondary Outcome Measures:
  • Change in Pad Weight Gain [ Time Frame: from the 14-day baseline period to the first 7 days of 14-day device usage period ] [ Designated as safety issue: No ]
    Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

  • 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 ] [ Designated as safety issue: No ]
    Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

  • Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: baseline and end-of-treatment ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pessary device
pessary (disposable intra-vaginal device)
Device: pessary (disposable intra-vaginal device)
pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762345

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     History of Changes
Other Study ID Numbers: 2012099 
Study First Received: December 12, 2012
Results First Received: January 15, 2016
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration

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
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 08, 2016