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

NCT05910983 | Not Yet Recruiting

• 1 other identifier: BPH and Botox
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Intravesical Botox; Bipolar enucleation of the prostate; BPH; Overactive Bladder; Bladder Outlet Obstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Adverse events

  Adverse events will be monitored throughout the entire study duration (6 months after the surgery)

Study Arms (2)

Patients receiving Bipolar enucleation of the prostate surgery only

EXPERIMENTAL

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.

Procedure: Bipolar enucleation of the prostate (BipolEP)

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

EXPERIMENTAL

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.

Procedure: Bipolar enucleation of the prostate (BipolEP); Drug: Intravesical Botox injection

Interventions

Bipolar enucleation of the prostate (BipolEP) PROCEDURE

Bipolar enucleation of the prostate (BipolEP)

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

Intravesical Botox injection 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).

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

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases

Central Study Contacts

Mohamed Kamal Omar, MD

CONTACT

+20 106 694 9454; Kimo_81eg@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for Bipolar enucleation of the prostate surgery for their urinary symptoms and also eligible for intravesical Botox injections. This cohort of patients will be recruited and randomized into two groups: a control group that would undergo BipolEP procedure only, and an experimental group that will undergo BipolEP procedure combined with an intravesical Botox injection.This study will utilize a 1:1 randomization scheme to assign participants to either the control group or the experimental group. Participants will not be blinded to the procedure they are receiving. No one on the study team including those involved in data analysis will be blinded to the study arm assignment. The investigators plan to recruit a maximum of 50 participants in each arm. The study's intervention is whether Botox injections are added during the surgery or not.

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 20, 2023
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05