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

NCT06097234 | Recruiting DMC FDA Device

• 1 other identifier: PLX-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 1.The devices under study alone
2. 2.The device under study plus 4 weekly visits with a pelvic floor physical therapist
3. 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

Keywords

pelvic floor; urinary incontinence; incontinence; pelvic floor training; biofeedback

Outcome Measures

Primary Outcomes (1)

• Change in stress urinary incontinence symptoms

  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

Study Arms (3)

Pelex Upp Device

ACTIVE COMPARATOR

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

Pelex Upp Device + Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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; Behavioral: Pelvic Floor Physical Therapy

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Pelex Upp DEVICE

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.

Pelex Upp Device; Pelex Upp Device + Pelvic Floor Physical Therapy

Pelvic Floor Physical Therapy BEHAVIORAL

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

Pelex Upp Device + Pelvic Floor Physical Therapy; Pelvic Floor Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pelex: lead

Study Sites (1)

Pelex

Little Neck, New York, 11363, United States

RECRUITING

Related Publications (15)

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  PMID: 27437306 BACKGROUND

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  PMID: 18877152 BACKGROUND

• Burns PA, Pranikoff K, Nochajski TH, Hadley EC, Levy KJ, Ory MG. A comparison of effectiveness of biofeedback and pelvic muscle exercise treatment of stress incontinence in older community-dwelling women. J Gerontol. 1993 Jul;48(4):M167-74. doi: 10.1093/geronj/48.4.m167.

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  PMID: 26883864 BACKGROUND

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• Chandrasekaran R. Telemedicine in the Post-Pandemic Period: Understanding Patterns of Use and the Influence of Socioeconomic Demographics, Health Status, and Social Determinants. Telemed J E Health. 2024 Feb;30(2):480-489. doi: 10.1089/tmj.2023.0277. Epub 2023 Aug 16.

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MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Central Study Contacts

Jeremy B Wiygul, MD

CONTACT

3476840176; jeremy@pelex-med.com

Ben Russo, MBA

CONTACT

9084197531; ben@pelex-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled prospective trial

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)