Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Incontinence Clinical Trial

Official title:

Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954042
• Other study ID #: URO-2016-25004
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: April 2021
• Source: Pelvital USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 a-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

Related Conditions & MeSH terms

• Enuresis
• Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Pelvital probe
Pelvital probe
• Placebo Probe
Placebo Probe

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Pelvital USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in severity of involuntary urine loss	Measured by pad testing	Baseline, 6 weeks
Secondary	incontinence episode frequency	Daily Diary	Baseline, 6 weeks
Secondary	health-related quality of life	Quality of Life questionarie	Baseline, 6 weeks