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NCT05938855: IncontiLib
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence.
NA trial testing Electrical stimulation and biofeedback with the medical device Phenix Liberty in Urinary Incontinence in 30 participants. Completed in 6 December 2024.
6 December 2024
Quick facts
| Lead sponsor | Vivaltis |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 6 May 2024 |
| Primary completion | 6 December 2024 |
| Estimated completion | 6 December 2024 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Electrical stimulation and biofeedback with the medical device Phenix Liberty
Conditions studied
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →
Sponsor
Vivaltis
Who can join
Adults 18 to 75, female only, with 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 evaluate the short-term improvement in urinary incontinence after perineo-sphincter rehabilitation using functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) in patients with pelvic statics disorders. • Does the use of the medical device in the treatment of pelvic static disorders lead to an improvement in urinary incontinence? Participants will use the medical device, which provides electrical stimulation, biofeedback and pressure biofeedback to re-educate the pelvic floor muscles and improve urinary incontinence.
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 NCT05938855
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Urinary Incontinence
Currently open trials in the same condition.
- NCT07430865 — The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation · NA · recruiting
- NCT07105150 — Efficacy of a Video-Based Educational Program on Female Urinary Incontinence · NA · recruiting
- NCT07426861 — Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence · NA · recruiting
- NCT07413692 — BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and E · NA · recruiting
- NCT07413705 — BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and · NA · recruiting
Other Vivaltis trials
Trials by the same sponsor.
- NCT05926739 — Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment · 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 NCT05938855 (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 Vivaltis
- Last refreshed: 16 December 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/NCT05938855.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing