NCT05878951 Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
| NCT ID | NCT05878951 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Northwestern University |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-07-13 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2023-07-13 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
Eligibility Criteria
Inclusion Criteria: * Males 18 -89 undergoing HoLEP * Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires. Exclusion Criteria: * Allergy or hypersensitivity to OnabotulinumtoxinA injections * Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP * Anticipated need for perineal urethrostomy at the time of HoLEP * Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy * Patients who lack decisional capacity * Active urinary tract infection
Contact & Investigator
Amy Krambeck, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05878951 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 89 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05878951 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05878951 currently recruiting?
Yes, NCT05878951 is actively recruiting participants. Contact the research team at Alyssa.McDonald@northwestern.edu for enrollment information.
Where is the NCT05878951 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05878951 clinical trial?
NCT05878951 is sponsored by Northwestern University. The principal investigator is Amy Krambeck, MD at Northwestern University. The trial plans to enroll 66 participants.