Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Not Applicable

Completed

• Conditions: Incontinence

• Registration Number: NCT02954042
• Lead Sponsor: Pelvital USA, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2017-03-10
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in severity of involuntary urine loss	Baseline, 6 weeks	Measured by pad testing

Secondary Outcome Measures

Name	Time	Method
incontinence episode frequency	Baseline, 6 weeks	Daily Diary
health-related quality of life	Baseline, 6 weeks	Quality of Life questionarie

Trial Locations

Locations (3)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Metro OBGYN; 🇺🇸 Maplewood, Minnesota, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States