The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder
Primary Purpose
Benign Prostatic Hyperplasia, Overactive Bladder
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravesical Botox injection
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Males age > 40
- Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for HoLEP 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
- University Hospitals Cleveland Medical Center
- UH Brainard Medical Bldg
- UH Regional Hospitals - Richmond Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Patients receiving HoLEP surgery only
Patients receiving HoLEP surgery + Intravesical Botox Injections
Arm Description
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. No Botox injections will be given.
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP 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
1. Study Identification
Unique Protocol Identification Number
NCT05393921
Brief Title
The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder
Official Title
The Clinical Efficacy of Intravesical Botox Injections When Combined With HoLEP Surgery in Patients With Benign Prostatic Hyperplasia and Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Zell, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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), Holmium Laser Enucleation of the Prostate (HoLEP), 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 HoLEP 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 HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP 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
Benign Prostatic Hyperplasia, Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
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 HoLEP 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 HoLEP procedure only, and an experimental group that will undergo HoLEP 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 HoLEP surgery only
Arm Type
No Intervention
Arm Description
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. No Botox injections will be given.
Arm Title
Patients receiving HoLEP surgery + Intravesical Botox Injections
Arm Type
Experimental
Arm Description
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. Botox injections will be given during the surgery.
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
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 HoLEP 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
Steven Madias
Phone
216-844-1447
Email
Steven.Madias@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zell, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Madias
Phone
216-844-1447
Email
Steven.Madias@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Michael Zell
Facility Name
UH Brainard Medical Bldg
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jad Badreddine
Phone
720-209-4069
Email
jad.badreddine@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Irina Jaeger
Facility Name
UH Regional Hospitals - Richmond Campus
City
Richmond Heights
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jad Badreddine
Phone
720-209-4069
Email
jad.badreddine@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Irina Jaeger, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available
Citations:
PubMed Identifier
17347660
Citation
Antunes AA, Srougi M, Coelho RF, de Campos Freire G. Botulinum toxin for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Nat Clin Pract Urol. 2007 Mar;4(3):155-60. doi: 10.1038/ncpuro0735.
Results Reference
background
PubMed Identifier
32086571
Citation
Ahyai SA, Marik I, Ludwig TA, Becker A, Asdjodi S, Kluth L, Chun F, Fisch M, Schmid M. Super early detailed assessment of lower urinary tract symptoms after holmium laser enucleation of the prostate (HoLEP): a prospective study. World J Urol. 2020 Dec;38(12):3207-3217. doi: 10.1007/s00345-020-03126-x. Epub 2020 Feb 21.
Results Reference
background
PubMed Identifier
17488531
Citation
Rapp DE, Lucioni A, Bales GT. Botulinum toxin injection: a review of injection principles and protocols. Int Braz J Urol. 2007 Mar-Apr;33(2):132-41. doi: 10.1590/s1677-55382007000200002.
Results Reference
background
PubMed Identifier
32617023
Citation
Allameh F, Basiri A, Razzaghi M, Abedi AR, Fallah-Karkan M, Ghiasy S, Hosseininia SM, Montazeri S. Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin - A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder: A Case-Control Study. Clin Pharmacol. 2020 Jun 26;12:75-81. doi: 10.2147/CPAA.S256051. eCollection 2020.
Results Reference
background
PubMed Identifier
29519236
Citation
Fusco F, Creta M, De Nunzio C, Iacovelli V, Mangiapia F, Li Marzi V, Finazzi Agro E. Progressive bladder remodeling due to bladder outlet obstruction: a systematic review of morphological and molecular evidences in humans. BMC Urol. 2018 Mar 9;18(1):15. doi: 10.1186/s12894-018-0329-4.
Results Reference
background
Learn more about this trial
The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder
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