Overactive Bladder Clinical Trial
— BPH BotoxOfficial title:
Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Menoufia University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in International Prostate Symptom Score (IPSS) | Comparing the change in IPSS score between the two arms across time | IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Overactive Bladder Symptoms Score (OABSS) | Comparing the change in OABSS score between the two arms across time | OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Maximum Urinary Flow rate | Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time | Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Post-Void Residual (PVR) Volume | Comparing the change in postvoid residual volume (mL) between the two arms across time | Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Secondary | Adverse events | Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded | Adverse events will be monitored throughout the entire study duration (6 months after the surgery) |
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