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

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 ThuLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Bladder Outlet Obstruction; BPH; Intravesical Botox; ThuLEP
• Intervention / Treatment: Drug: Intravesical Botox injection; Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP)

Detailed Description

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 negative impact on the patients' quality of life.

Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Thulium Laser Enucleation of the Prostate (ThuLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these.

A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.

Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).

The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.

The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during ThuLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).

The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.

The investigators hypothesize that administering bladder botox injections during ThuLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a ThuLEP surgery for their obstructive and irritative symptoms

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Kamal Omar, MD; Phone Number: +20 106 694 9454; Email: Kimo_81eg@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males age > 40
• Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for ThuLEP 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving ThuLEP surgery only; 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for ThuLEP to treat their urinary symptoms. No Botox injections will be given.	Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP); Thulium Laser Enucleation of the Prostate
Experimental: Patients receiving ThuLEP surgery + Intravesical Botox Injections; 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for ThuLEP to treat their urinary symptoms. Botox injections will be given during the surgery.	Drug: Intravesical Botox injection; Intravesical botox injection given only in experimental group.100 units of Botox will be used and diluted in 10 mL of normal saline. 0.5 cc injections will be administered in 20 injection sites (trigone sparing).; Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP); Thulium Laser Enucleation of the Prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Overactive Bladder; BPH; Bladder Outlet Obstruction; ThuLEP; Intravesical Botox
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: BPH and Botox

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No