Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Conditions
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Incontinence

Intervention / Treatment
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* Device: Pelvital probe
* Device: Placebo Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvital probe<br>Probe to use for incontinence-Pevital is company name of product | Device: Pelvital probe<br>* Pelvital probe<br>|
| Placebo Comparator: Placebo Probe<br>Placebo probe | Device: Placebo Probe<br>* Placebo Probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in severity of involuntary urine loss | Measured by pad testing | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incontinence episode frequency | Daily Diary | Baseline, 6 weeks | 
| health-related quality of life | Quality of Life questionarie | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incontinence