Back to resultsA Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
Primary Purpose
Stress Urinary Incontinence (SUI)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
disposable, single-use pessary
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence (SUI) focused on measuring single use, disposable, pessary, stress urinary incontinence, sui
Eligibility Criteria
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.
Sites / Locations
- Study Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pessary
Arm Description
disposable, single-use pessary
Outcomes
Primary Outcome Measures
Percentage of Responders for Pad Weight Gain or SUI Episodes
Secondary Outcome Measures
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 Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. 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.
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 Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Percentage of Responders for Pad Weight Gain or SUI Episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131311
Brief Title
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
Official Title
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence (SUI)
Keywords
single use, disposable, pessary, 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
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pessary
Arm Type
Experimental
Arm Description
disposable, single-use pessary
Intervention Type
Device
Intervention Name(s)
disposable, single-use pessary
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
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
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 Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
Description
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.
Time Frame
baseline and end-of-treatment
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 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 a 14-day device usage period
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
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