Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity

Launched by MENOUFIA UNIVERSITY · Jun 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to help men with urinary problems caused by an enlarged prostate, a condition known as Benign Prostatic Hyperplasia (BPH). The study will investigate whether giving Botox injections directly into the bladder during a specific type of prostate surgery, called Bipolar enucleation, can improve symptoms like frequent urination, urgency, and incontinence. The goal is to see if this combined treatment can provide better relief for men who have trouble urinating because of bladder outlet obstruction and overactive bladder symptoms.

To participate in the trial, men must be over 40 years old, diagnosed with BPH, and have significant urinary symptoms that have not improved with other treatments, like medications. Participants will be required to have a specific level of urinary symptoms and must not have certain medical conditions, such as a history of bladder or prostate cancer. The study is not yet recruiting, but once it begins, eligible participants can expect to receive the Botox injections during their surgery and will be monitored for improvements in their symptoms. This trial could potentially offer a new treatment option for men struggling with these urinary issues.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Males age \> 40
• • Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) 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