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

NCT ID: NCT05910983

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-01

Brief Summary

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).

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 Bipolar prostate enucleation (BipolEP) 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 BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms

Conditions

BPH; Intravesical Botox; Bipolar Enucleation of the Prostate; Overactive Bladder; Bladder Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving Bipolar enucleation of the prostate surgery only

50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. No Botox injections will be given.

Group Type: EXPERIMENTAL

Bipolar enucleation of the prostate (BipolEP)

Intervention Type: PROCEDURE

Bipolar enucleation of the prostate (BipolEP)

Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections

50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. Botox injections will be given during the surgery.

Group Type: EXPERIMENTAL

Bipolar enucleation of the prostate (BipolEP)

Intervention Type: PROCEDURE

Bipolar enucleation of the prostate (BipolEP)

Intravesical Botox injection

Intervention Type: DRUG

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).

Interventions

Bipolar enucleation of the prostate (BipolEP)

Bipolar enucleation of the prostate (BipolEP)

Intervention Type: PROCEDURE

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Kamal Omar

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Kamal Omar, MD

Role: CONTACT

Kimo_81eg@yahoo.com

+20 106 694 9454

Other Identifiers

BPH and Botox

Identifier Type: -

Identifier Source: org_study_id