Clinical trial NCT02131311: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence (SUI)
Keywords: single use
disposable
pessary
stress urinary incontinence
sui
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Responders for Pad Weight Gain or SUI Episodes
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Secondary outcomes:
measure: Change in Stress Urinary Incontinence Episodes
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
measure: Change in Pad Weight Gain
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
measure: Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
timeFrame: baseline and end-of-treatment
measure: Change in Stress Urinary Incontinence Episodes
timeFrame: from the 14-day baseline period to the first 7 days of 14-day device usage period
measure: Change in Pad Weight Gain
timeFrame: from the 14-day baseline period to the first 7 days of a 14-day device usage period
measure: Percentage of Responders for Pad Weight Gain or SUI Episodes
timeFrame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Study Center
state: Arizona
Study officials:
affiliation: Radiant Research, Inc.
name: Randall Severance, MD
role: PRINCIPAL_INVESTIGATOR
References: