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NCT03978741
Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
NA trial testing Yōni.Fit Test Device in Urinary Incontinence in 80 participants. Completed in 26 August 2022.
5 May 2022
Quick facts
| Lead sponsor | Watkins Conti Products. Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 3 January 2020 |
| Primary completion | 5 May 2022 |
| Estimated completion | 26 August 2022 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Yōni.Fit Test Device
- Yōni.Fit Comparator Device
Conditions studied
- Urinary Incontinence — all drugs for Urinary Incontinence →
Sponsor
Watkins Conti Products. Inc.
Who can join
Adults 18 to 100, female only, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.
Ontario Health (Quality) . · · 2021 · cited 6× · PMID 34055111 -
A Randomized Controlled Trial of a Novel Device for Stress Incontinence.
Escobar C, Sokol ER, Rosenblum N, Milikien D, et al · · 2026 · PMID 40288810 · DOI 10.1097/spv.0000000000001676
Verify or expand the search:
- PubMed search for NCT03978741
- 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 Watkins Conti Products. Inc. trials
Trials by the same sponsor.
- NCT03010800 — A Feasibility Device Study to Prevent Female Urinary Stress 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 NCT03978741 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Watkins Conti Products. Inc.
- Last refreshed: 8 May 2023
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/NCT03978741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing