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Completed

NCT Number: NCT02131311

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

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.

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Key information

Conditions

Stress Urinary Incontinence (SUI) 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

  • 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.

Treatment and study plan

disposable, single-use pessary

Device

Primary outcomes

  1. Percentage of Responders for Pad Weight Gain or SUI Episodes

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

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. Change in Pad Weight Gain

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

    change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

  6. Percentage of Responders for Pad Weight Gain or SUI Episodes

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

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 6, 2014
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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