Pelvital Stress Urinary Incontinence Training Device: P-SUIT

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

Study Overview

• Status: Completed
• Conditions: Incontinence
• Intervention / Treatment: Device: Pelvital probe; Device: Placebo Probe

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • University of Minnesota Medical Center
    • Maplewood, Minnesota, United States, 55109
      • Metro OBGYN
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pelvital USA, Inc.
• Investigators: Principal Investigator: Nissrine Nakib, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: URO-2016-25004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No