Botox injection into the bladder at the time of prostate surgery to reduce overactive bladder symptoms.
Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms
This test looks at whether a Botox shot into the bladder given during TURP or Aquablation helps men with BPH who have overactive bladder symptoms feel better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Benaroya Research Institute Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07377929 on ClinicalTrials.gov |
What this trial studies
Men scheduled for transurethral resection of the prostate (TURP) or transurethral waterjet ablation (Aquablation) who have baseline overactive bladder symptoms receive intradetrusor onabotulinumtoxinA (Botox) at the time of their procedure. Outcomes are tracked using patient questionnaires about urinary frequency, urgency, and recovery in the immediate postoperative period and at follow-up. The study excludes non-English speakers and anyone who received bladder Botox within the prior 12 months. This is an observational registry-style protocol collecting real-world symptom data around routine clinical care rather than assigning treatments by randomization.
Who should consider this trial
Good fit: Men aged 18 or older who are scheduled for TURP or Aquablation, have overactive bladder symptoms, can provide informed consent, and can complete English-language questionnaires are the ideal candidates.
Not a fit: Patients without overactive bladder symptoms, those who received bladder Botox within the last 12 months, or those unable to complete English questionnaires are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, giving Botox at the time of prostate surgery could reduce early postoperative urgency and frequency and speed symptom recovery.
How similar studies have performed: Botox is an FDA-approved and effective treatment for overactive bladder, but using it at the time of prostate surgery is relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male \>= 18 years of age and being scheduled to undergo TURP or Aquablation and Botox procedure. 2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: 3. Non-English speaking 4. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 5. History of receiving Botox in the bladder, within the previous 12 months.
Where this trial is running
Seattle, Washington
- Virginia Mason Franciscan Health — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Thomas W. Fuller, MD
- Email: will.fuller@commonspirit.org
- Phone: 206-223-6772
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.