Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Completed · Not applicable · Has a placebo group

Conditions studied: Incontinence

In brief

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

Key facts

Study ID

NCT02954042

Run by

Pelvital USA, Inc.

People needed

120

Starts

2017-03-10

Expected to finish

2019-10-30

Last updated by the study team

2021-04-14

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female gender,
• Ages 18-75,
• Clinical diagnosis of stress urinary incontinence,
• Ability to contract the pelvic floor muscles,
• Able to document incontinence and voiding in a diary,
• Provision of written informed consent form,
• Minimum of 10 grams increase at initial 24-hour pad weight test

You may not qualify if…

• Diagnosed mixed or urge urinary incontinence,
• Impaired cognitive function or neurologic conditions
• Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
• Acute infections or hematuria,
• Pregnant or actively trying to conceive,
• History of pelvic irradiation,
• Concurrent medications with α-adrenergic antagonists or diuretics
• Pelvic organ prolapse stage III or IV,
• Severe urethral sphincter weakness and/or defect,
• Suspected urethral and/or vesical fistula

Where it is running

• University of Minnesota Medical Center — Maple Grove, Minnesota, United States
• Metro OBGYN — Maplewood, Minnesota, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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