Pelvital Stress Urinary Incontinence Training Device: P-SUIT



Status:Recruiting
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:5/3/2018
Start Date:March 10, 2017
End Date:December 2019
Contact:Bethany Marlette
Email:marle025@umn.edu
Phone:612-626-6661

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The purpose of this investigation is to compare the clinical benefits of using the Pelvital
product, in comparison to a sham procedure as a noninvasive treatment for female incontinence

120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled
crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control
arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects
will conduct their respective therapy five minutes a day over the course of six weeks. At
weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all
patients in the control arm will have the option to cross over into the treatment arm if no
improvement in symptoms has been shown.

Inclusion Criteria:

1. Female gender,

2. Ages 18-75,

3. Clinical diagnosis of stress urinary incontinence,

4. Ability to contract the pelvic floor muscles,

5. Able to document incontinence and voiding in a diary,

6. Provision of written informed consent form,

7. Minimum of 10 grams increase at initial 24-hour pad weight test

Exclusion Criteria:

1. Diagnosed mixed or urge urinary incontinence,

2. Impaired cognitive function or neurologic conditions

3. Physical limitations that impede the patient's ability to participate (e.g., ability
to stand),

4. Acute infections or hematuria,

5. Pregnant or actively trying to conceive,

6. History of pelvic irradiation,

7. Concurrent medications with α-adrenergic antagonists or diuretics

8. Pelvic organ prolapse stage III or IV,

9. Severe urethral sphincter weakness and/or defect,

10. Suspected urethral and/or vesical fistula
We found this trial at
4
sites
Minneapolis, Minnesota 55455
Principal Investigator: Nissrine Nakib, MD
Phone: 612-626-6661
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Maple Grove, Minnesota 55369
Principal Investigator: Nissrine Nakib, MD
Phone: 763-898-1714
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Maplewood, Minnesota 55109
Principal Investigator: Kevin Hallman, MD
Phone: 651-265-6770
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Suzette Sutherland, MD
Phone: 206-616-8723
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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