Clinical trial NCT05624645: Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
Official title: Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Urinary Incontinence
Pelvic Floor Disorders
Keywords: stress urinary incontinence
pelvic floor disorders
Lead sponsor: Pelex
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in stress urinary incontinence symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Neck
country: United States
facility: Pelex
state: New York
Study officials:
affiliation: Pelex
name: Jeremy Wiygul, M.D.
role: PRINCIPAL_INVESTIGATOR
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