Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence

The goal of this clinical trial is to assess the efficacy and usability of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence. 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?

Participants will be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pelex

Little Neck, New York, 11363, United States

About this study

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 a study brochure, and then 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 given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five 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).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or less than 12 months post partum

History of physician-supervised PFMT

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

Treatment and study plan

Pelex Upp

Device

Patients were given the Pelex Upp is a non-invasive device that is designed to guide a user through personalized pelvic floor strengthening exercises. Patients used device for four weeks to treat stress urinary incontinence

Primary outcomes

Change in stress urinary incontinence symptoms

Time frame: 4 weeks

Patients were given the ICIQ-UI SF, the standard assessment tool for stress and urge urinary incontinence, both before initiation and at the end of study. 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.

Sponsors and collaborators

Lead sponsor

Pelex

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Nov 22, 2022
Registry last updated: Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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