Status:
WITHDRAWN
The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Benign Prostatic Hyperplasia
Overactive Bladder
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief Summary
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant nega...
Eligibility Criteria
Inclusion
- Males age \> 40
- Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for HoLEP surgery
- Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections
- International Prostate Symptom Score (IPSS) ≥ 17
- Overactive Bladder Symptom Score (OABSS) ≥ 7
- Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB
Exclusion
- History of bladder/prostate cancer
- History of pelvic radiotherapy
- History of neurological diseases
- Presence of active Urinary Tract Infection (UTI)
- Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..)
- History of adverse reaction to Botox injections
- Post-void residual (PVR) greater than 300 ml
- History of clean intermittent catheterization
- Patients unable to stop anticoagulation of antiplatelet inhibitors 3 days prior to procedure
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05393921
Start Date
June 1 2026
End Date
July 1 2027
Last Update
September 5 2025
Active Locations (3)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
2
UH Brainard Medical Bldg
Lyndhurst, Ohio, United States, 44124
3
UH Regional Hospitals - Richmond Campus
Richmond Heights, Ohio, United States, 44143