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Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.

NCT06097234 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-03-29

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy.

The main questions it aims to answer are:

Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy?

Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone?

Participants will be given one of three treatments:

1. The devices under study alone
2. The device under study plus 4 weekly visits with a pelvic floor physical therapist
3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Conditions

  • Stress Urinary Incontinence
  • Pelvic Floor Disorders

Interventions

DEVICE

Pelex Upp

Biofeedback-mediated pelvic floor trainer. It captures contraction and relaxation of the pelvic floor muscles during use by the subject, and represents these contractions and relaxations back to the subject to improve conscious control of the muscle groups.

BEHAVIORAL

Pelvic Floor Physical Therapy

A form of physical therapy whereby the subject is given instructions on how to identify the pelvic floor, how to coordinate the pelvic floor contractions and relaxations, as well as counseling on dietary changes that affect pelvic floor and pelvic organ function

Sponsors & Collaborators

  • Pelex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-01
Completion
2024-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097234 on ClinicalTrials.gov