Reduction in Number of Botox Injections for Urgency Urinary Incontinence (NCT04731961)
Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Virginia — Charlottesville, Virginia
Age range: 21 Years
🧪 Interventions in This Study
- Standard of care (15 Botox injections) (PROCEDURE)
- Experimental Arm (5 Botox injections) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Virginia — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (434) 924-1955
Email: MV4W@hscmail.mcc.virginia.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urgency Urinary Incontinence
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- Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women — Pittsburgh, Pennsylvania
- Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial — Managua, Managua Department
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.