Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Pelvital USA, Inc.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Incontinence

Interventions

Pelvital probeDEVICE

Pelvital probe

Placebo ProbeDEVICE

Placebo Probe

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Improvement in severity of involuntary urine loss

Measured by pad testing

Time frame: Baseline, 6 weeks

Secondary Outcomes

incontinence episode frequency

Daily Diary

Time frame: Baseline, 6 weeks

health-related quality of life

Quality of Life questionarie

Time frame: Baseline, 6 weeks

Data from ClinicalTrials.gov

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