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

Primary Purpose

BPH, Intravesical Botox, ThuLEP

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thulium Laser Enucleation of the Prostate (ThuLEP)
Intravesical Botox injection
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH focused on measuring Intravesical Botox, ThuLEP, BPH, Overactive Bladder, Bladder Outlet Obstruction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients receiving ThuLEP surgery only

    Patients receiving ThuLEP surgery + Intravesical Botox Injections

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Adverse events
    Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded

    Full Information

    First Posted
    June 11, 2023
    Last Updated
    June 11, 2023
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05910983
    Brief Title
    Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity
    Acronym
    BPH Botox
    Official Title
    Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BPH, Intravesical Botox, ThuLEP, Overactive Bladder, Bladder Outlet Obstruction
    Keywords
    Intravesical Botox, ThuLEP, BPH, Overactive Bladder, Bladder Outlet Obstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients receiving ThuLEP surgery only
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Patients receiving ThuLEP surgery + Intravesical Botox Injections
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thulium Laser Enucleation of the Prostate (ThuLEP)
    Intervention Description
    Thulium Laser Enucleation of the Prostate
    Intervention Type
    Drug
    Intervention Name(s)
    Intravesical Botox injection
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change in International Prostate Symptom Score (IPSS)
    Description
    Comparing the change in IPSS score between the two arms across time
    Time Frame
    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
    Title
    Change in Overactive Bladder Symptoms Score (OABSS)
    Description
    Comparing the change in OABSS score between the two arms across time
    Time Frame
    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
    Title
    Change in Maximum Urinary Flow rate
    Description
    Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time
    Time Frame
    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
    Title
    Change in Post-Void Residual (PVR) Volume
    Description
    Comparing the change in postvoid residual volume (mL) between the two arms across time
    Time Frame
    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 Measure Information:
    Title
    Adverse events
    Description
    Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded
    Time Frame
    Adverse events will be monitored throughout the entire study duration (6 months after the surgery)

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Kamal Omar, MD
    Phone
    +20 106 694 9454
    Email
    Kimo_81eg@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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