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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: Completed NA study, sponsored by Pelex.
NCT05624645 is a NA study that has completed, run by Pelex. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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 qua
Interventions
- DEVICE Pelex Upp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2022-01-18 |
| Phase | NA |
What the finished NCT05624645 record still lists
NCT05624645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Pelex Upp is the first listed.
NCT05624645 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05624645's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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