Effects of Botox injections during prostate surgery for men with overactive bladder symptoms
A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms
PHASE2; PHASE3 · Northwestern University · NCT05878951
This study is testing if Botox injections given during prostate surgery can help men with overactive bladder symptoms feel better and need fewer medications afterward.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Male |
| Sponsor | Northwestern University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05878951 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized single-blind study aims to evaluate the safety and effectiveness of intra-detrusor OnabotulinumtoxinA injections administered at the time of holium laser enucleation of the prostate (HoLEP) in men experiencing overactive bladder symptoms, including urgency and urge urinary incontinence. The study will involve male participants aged 18 to 89 who are undergoing HoLEP due to benign prostatic hyperplasia (BPH) and have significant lower urinary tract symptoms. The research will assess whether the Botox injections can alleviate symptoms and reduce the need for additional medications post-surgery.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 89 undergoing HoLEP with significant overactive bladder symptoms.
Not a fit: Patients with allergies to OnabotulinumtoxinA or those requiring concurrent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve urinary symptoms and quality of life for men suffering from overactive bladder.
How similar studies have performed: Previous studies have shown promising results with similar approaches using Botox for overactive bladder symptoms, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern Medicine — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Amy Krambeck, MD — Northwestern University
- Study coordinator: Alyssa McDonald
- Email: Alyssa.McDonald@northwestern.edu
- Phone: 312-695-8146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases