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NCT06097234 · ClinicalTrials.gov registry record · NA
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
A NA study of Stress Urinary Incontinence and Pelvic Floor Disorders, sponsored by Pelex.
- Recruiting
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06097234 is a NA study of Stress Urinary Incontinence and Pelvic Floor Disorders that is actively recruiting participants, run by Pelex. The registered enrollment target is 45 participants, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06097234, a NA study of Stress Urinary Incontinence and Pelvic Floor Disorders, is actively recruiting participants, sponsored by Pelex.
- RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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. 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).
Conditions Studied
Interventions
- DEVICE Pelex Upp
- BEHAVIORAL Pelvic Floor Physical Therapy
Study Locations (1)
New York
- Pelex - Little Neck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2024-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06097234
The ClinicalTrials.gov registry entry for NCT06097234 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (72% lower). The listed sponsor is Pelex, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Pelex Upp is the first listed.
NCT06097234 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06097234 about?
NCT06097234 is a clinical study titled "Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.". 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 wit...
What is the current status of trial NCT06097234?
This trial is currently recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2024-01-01. Estimated completion is 2024-07-01.
What conditions does trial NCT06097234 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Pelvic Floor Disorders.
What interventions are being tested in trial NCT06097234?
The interventions under investigation include: Pelex Upp (DEVICE), Pelvic Floor Physical Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06097234?
This trial is sponsored by Pelex, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06097234 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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