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

Sponsor

Menoufia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05910983

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
BPH Intravesical Botox ThuLEP Overactive Bladder Bladder Outlet Obstruction	Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP) Drug: Intravesical Botox injection	N/A

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for ThuLEP 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 ThuLEP procedure only, and an experimental group that will undergo ThuLEP 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.This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for ThuLEP 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 ThuLEP procedure only, and an experimental group that will undergo ThuLEP 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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.	Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP) Thulium Laser Enucleation of the Prostate 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).

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.

Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP)

Thulium Laser Enucleation of the Prostate

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).

Outcome Measures

Primary Outcome Measures

Change in International Prostate Symptom Score (IPSS) [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]
Comparing the change in IPSS score between the two arms across time
Change in Overactive Bladder Symptoms Score (OABSS) [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]
Comparing the change in OABSS score between the two arms across time
Change in Maximum Urinary Flow rate [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]
Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time
Change in Post-Void Residual (PVR) Volume [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]
Comparing the change in postvoid residual volume (mL) between the two arms across time

Secondary Outcome Measures

Adverse events [Adverse events will be monitored throughout the entire study duration (6 months after the surgery)]
Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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