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Completed

NCT Number: NCT01762345

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Study Center

Chandler, Arizona, 85224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pessary (disposable intra-vaginal device)

Device

pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2013
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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