Back to resultsA Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pessary
Absorbent pad
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, SUI, pessary
Eligibility Criteria
Inclusion Criteria:
- be female 18 years or older;
- provide written informed consent prior to study participation and been given a signed copy;
- be in generally good health as determined by the Investigator;
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (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:
- are 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 and could impact the safety of the subject or the outcome of the study; or
- 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 2
Arm Type
Placebo Comparator
Experimental
Arm Label
pad
pessary
Arm Description
absorbent pad control
disposable, single-use pessary
Outcomes
Primary Outcome Measures
Treatment-emergent Serious Adverse Event
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02160314
Brief Title
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Official Title
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (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 safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
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, pessary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pad
Arm Type
Placebo Comparator
Arm Description
absorbent pad control
Arm Title
pessary
Arm Type
Experimental
Arm Description
disposable, single-use pessary
Intervention Type
Device
Intervention Name(s)
pessary
Intervention Description
disposable, single-use pessary
Intervention Type
Device
Intervention Name(s)
Absorbent pad
Other Intervention Name(s)
placebo comparator
Primary Outcome Measure Information:
Title
Treatment-emergent Serious Adverse Event
Description
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
Time Frame
3 month
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 been given a signed copy;
be in generally good health as determined by the Investigator;
have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (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:
are 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 and could impact the safety of the subject or the outcome of the study; or
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 to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
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