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NCT04731961
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
NA trial testing Standard of care (15 Botox injections) in Urgency Urinary Incontinence in 56 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 23 February 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Standard of care (15 Botox injections)
- Experimental Arm (5 Botox injections)
Conditions studied
- Urgency Urinary Incontinence — all drugs for Urgency Urinary Incontinence →
Sponsor
University of Virginia
Who can join
21 and older, female only, with Urgency Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04731961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Urgency Urinary Incontinence
Currently open trials in the same condition.
- NCT05806164 — Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence · Phase 4 · recruiting
- NCT05512039 — Reduced-dose Botox for Urgency Incontinence Among Elder Females · Phase 1, PHASE2 · active not recruiting
- NCT05604222 — Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women · Phase 4 · recruiting
- NCT04599088 — Investigation of Brain Mechanisms Involved in the Urinary Continence Mechanism Associated With Aging · NA · active not recruiting
Other University of Virginia trials
Trials by the same sponsor.
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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 NCT04731961 (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 University of Virginia
- Last refreshed: 28 January 2025
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/NCT04731961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing