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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

pessary (disposable intra-vaginal device)

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, SUI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pessary device

Arm Description

pessary (disposable intra-vaginal device)

Outcomes

Primary Outcome Measures

Change in Pad Weight Gain

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

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

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

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)

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.

Full Information

NCT ID

NCT01762345

First Posted

December 12, 2012

Last Updated

February 23, 2016

Sponsor

Procter and Gamble

1. Study Identification

Unique Protocol Identification Number

NCT01762345

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Procter and Gamble

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

Stress urinary incontinence, SUI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pessary device

Arm Type

Experimental

Arm Description

pessary (disposable intra-vaginal device)

Intervention Type

Device

Intervention Name(s)

pessary (disposable intra-vaginal device)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pad Weight Gain

Description

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

Time Frame

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

Title

Change in Stress Urinary Incontinence Episodes

Description

Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Pad Weight Gain

Description

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

Time Frame

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

Title

Change in Stress Urinary Incontinence Episodes

Description

Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Time Frame

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

Title

Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)

Description

Time Frame

baseline and end-of-treatment

Other Pre-specified Outcome Measures:

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randall Severance, MD

Organizational Affiliation

Radiant Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Study Center

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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