Stress Urinary Incontinence (SUI)NCT02131311
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
A study testing disposable, single-use pessary in people with Stress Urinary Incontinence (SUI), run by Procter and Gamble at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- disposable, single-use pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2014
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- disposable, single-use pessary
- Keywords
- single use, disposable, pessary, stress urinary incontinence, sui
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable, single-use pessaryDevice
| Study group | Role | What they receive |
|---|---|---|
| pessary | Experimental | disposable, single-use pessary Receives: Device: disposable, single-use pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders for Pad Weight Gain or SUI Episodes
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period
Secondary outcomes (6)
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.
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period
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.
Measured: baseline and end-of-treatment
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.
Measured: from the 14-day baseline period to the first 7 days of 14-day device usage period
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the first 7 days of a 14-day device usage period
Percentage of Responders for Pad Weight Gain or SUI Episodes
Measured: from the 14-day baseline period to the first 7 days of 14-day device usage period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Severance, MD, Principal investigator, Radiant Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131311
- Sponsor's protocol ID
- 2012118
- Status last verified
- Feb 2016
- First submitted
- 2 May 2014
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No