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NCT03632447
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
NA trial testing Leva in Stress Urinary Incontinence in 77 participants. Completed in 1 October 2019.
1 August 2019
Quick facts
| Lead sponsor | Renovia, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 24 October 2018 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 October 2019 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Leva
- PFDx
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
- Mixed Urinary Incontinence — all drugs for Mixed Urinary Incontinence →
Sponsor
Renovia, Inc.
Who can join
Adults 18 to 89, female only, with Stress Urinary Incontinence or Mixed Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03632447
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stress Urinary Incontinence
Currently open trials in the same condition.
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- NCT06840093 — Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial · NA · recruiting
- 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 Renovia, Inc. trials
Trials by the same sponsor.
- NCT04508153 — Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence · NA · completed
- NCT04027335 — Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence · NA · unknown
- NCT03536923 — Use of the Leva Incontinence System in Treating Bladder 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 NCT03632447 (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 Renovia, Inc.
- Last refreshed: 8 October 2020
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/NCT03632447.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing