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NCT05624645 · ClinicalTrials.gov registry record · NA
Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
A NA study, sponsored by Pelex.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05624645 is a NA study that has completed, run by Pelex. The registered enrollment target is 5 participants.
The verdict
NCT05624645, a NA study, has completed, sponsored by Pelex.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study 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).
Interventions
- DEVICE Pelex Upp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2022-01-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05624645
The ClinicalTrials.gov registry entry for NCT05624645 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pelex, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pelex Upp is the first listed.
NCT05624645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05624645 about?
NCT05624645 is a clinical study titled "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 sym...
What is the current status of trial NCT05624645?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2021-02-25. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT05624645?
The interventions under investigation include: Pelex Upp (DEVICE).
Who is sponsoring clinical trial NCT05624645?
This trial is sponsored by Pelex, which has 2 total clinical trials registered on ClinicalTrials.gov.
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