The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the combined effect of Botox injections and a specific type of surgery called HoLEP (Holmium Laser Enucleation of the Prostate) on men who have issues with an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH), and overactive bladder symptoms. The aim is to see if giving Botox injections at the same time as the surgery can help improve urinary symptoms more effectively than doing them separately. Many men experience ongoing urinary problems even after surgery, and this study hopes to find a better treatment approach for those who struggle with these symptoms.

To participate in this trial, men over the age of 40 who have been diagnosed with BPH and have significant urinary issues may be eligible. Key criteria include having certain scores that indicate severe urinary symptoms and having tried other medications without success. Participants will receive either the combined treatment (Botox during HoLEP) or just the surgery, and they will be monitored for relief from symptoms at various points after the procedure. It's important to know that certain medical histories, like previous cancer treatments or urinary infections, could disqualify someone from joining the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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