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NCT06097234
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
NA trial testing Pelex Upp in Stress Urinary Incontinence in 45 participants. Status unknown.
1 July 2024
Quick facts
| Lead sponsor | Pelex |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 1 January 2024 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pelex Upp
- Pelvic Floor Physical Therapy
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
- Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →
Sponsor
Pelex
Who can join
18 and older, female only, with Stress Urinary Incontinence or Pelvic Floor Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06097234
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Related trials
Other trials of Pelex Upp
Trials testing the same drug.
- NCT05624645 — Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence · NA · completed
Other recruiting trials for Stress Urinary Incontinence
Currently open trials in the same condition.
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- NCT06111209 — The Anabolic Effect of Testosterone on Pelvic Floor Muscles · Phase 2 · recruiting
- NCT06731985 — The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes. · recruiting
Other Pelex trials
Trials by the same sponsor.
- NCT05624645 — Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06097234 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pelex
- Last refreshed: 29 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06097234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing