Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Med… (NCT07554989) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms
Turkey (Türkiye)70 participantsStarted 2026-04-01
Plain-language summary
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male patients aged 40 years and older who were diagnosed with benign prostatic hyperplasia and underwent transurethral resection of the prostate (TURP) or a similar endoscopic prostate surgery were included in the study
Exclusion Criteria:
* Neurological Pathologies:
* Diagnosis of neurogenic bladder.
* History of Multiple Sclerosis, Parkinson's disease, or cerebrovascular accident (CVA).
* Spinal cord injury or any other conditions leading to neurogenic bladder dysfunction.
Metabolic and Systemic Diseases:
* Diabetes Mellitus with associated neuropathy.
* Severe renal impairment (eGFR \<30 ml/min/1.73 m²).
* Severe hepatic impairment (Child-Pugh C).
* Moderate hepatic impairment (Child-Pugh B) or severe renal impairment in patients using strong CYP3A inhibitors.
Urinary System Related Pathologies:
* Previous treatment with intravesical BoNT-A or Mirabegron.
* Active urinary tract infection (confirmed by positive urine culture).
* Presence of bladder tumor, bladder stones, or bladder diverticulum.
* History of pelvic radiotherapy.
* Urethral stricture or conditions carrying a risk of re-obstruction.
Cardiovascular Risks (Contraindications for Mirabegron and Anticholinergics):
* Uncontrolled hypertension (≥180/110 mmHg).
* Severe cardiac arrhythmia or heart failure (NYHA Class III-IV).
Other Exclusion Criteria:
* Patients planning to receive other overactive bladder (OAB) treatments during the study period.
* Incomplete follow-up data or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Overactive Bladder Symptom Score (OABSS)
Timeframe: Baseline (Preoperative) and Postoperative 12th Week