RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-01
Study Completion:2024-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06097234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire
  1. * History of pelvic or lower back surgery
  2. * Pregnancy
  3. * History of physician-supervised pelvic floor muscle training
  4. * History of Kegel exercises greater than once a month
  5. * History of prior operative delivery
  6. * Self-reported history of pelvic organ prolapse stage II or greater

Contacts and Locations

Study Contact

Jeremy B Wiygul, MD
CONTACT
3476840176
jeremy@pelex-med.com
Ben Russo, MBA
CONTACT
9084197531
ben@pelex-med.com

Study Locations (Sites)

Pelex
Little Neck, New York, 11363
United States

Collaborators and Investigators

Sponsor: Pelex

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2024-07-01

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2024-07-01

Terms related to this study

Keywords Provided by Researchers

  • pelvic floor
  • urinary incontinence
  • incontinence
  • pelvic floor training
  • biofeedback

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence
  • Pelvic Floor Disorders