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

March 28, 2024 updated by: Pelex

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective cohort study of women > 18 years of age with symptoms of stress urinary incontinence, recruited via an online recruitment tool.

After screening, patients meeting inclusion criteria will be given instructions on how to indicate desire to participate in the study. The patient will then be contacted for study participation, including explanation of study and details and completion of Informed Consent. Participants will then complete a pre-treatment urinary incontinence symptom questionnaire(ICIQ).

After completion of the above, the participants will then be randomized to one of three arms:

  1. Pelex Upp (study device) only
  2. Pelvic floor physical therapy + Pelex Upp(device under study)
  3. Pelvic floor physical therapy only

For those given a Pelex Upp, they will also receive educational materials on use of the device, and a treatment schedule. For those participants given a Pelex Upp, a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, four times a week for 4 weeks, will be performed. For those subjects undergoing pelvic floor physical therapy only, they will perform Kegel exercises on a similar schedule. 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).

Endpoint of the study will be change in stress urinary incontinence symptoms as measured by the ICIQ. The ICIQ will be collected at 2 time points: before study entry, and at study close.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Female

  • 18 years of age or older
  • Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Exclusion Criteria:

  • History of pelvic or lower back surgery
  • Pregnancy
  • History of physician-supervised pelvic floor muscle training
  • History of Kegel exercises greater than once a month
  • History of prior operative delivery
  • Self-reported history of pelvic organ prolapse stage II or greater

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pelex Upp Device
Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.
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.
Active Comparator: Pelex Upp Device + Pelvic Floor Physical Therapy

Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.

In addition, subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide further care instructions and pelvic floor training.
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
Active Comparator: Pelvic Floor Physical Therapy
Subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide care instructions and pelvic floor training, as well as provide a weekly treatment schedule for Kegel exercises.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stress urinary incontinence symptoms
Time Frame: 4 weeks

Patients are given the ICIQ-UI SF, the standard assessment tool for stress and urge urinary incontinence, both before initiation and at the end of study, as well as the UDI, a measure of the impact of incontinence on quality of life. The difference between the two scores was then assessed to determine whether an change in stress urinary incontinence symptoms occurred after use of the device.

ICIQ is the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form is a four question survey to "evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women." It has a maximum and minimum score of 21 and 0 respectively. Higher scores reflect more significant urinary incontinence symptoms.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pelex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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