The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder

Michael Zell, MD

Status and phase: Begins enrollment this month; Phase 4

Conditions: Benign Prostatic Hyperplasia; Overactive Bladder

Treatments: Drug: Intravesical Botox injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05393921

STUDY20220495

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients receiving HoLEP surgery only

No Intervention group

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.

Patients receiving HoLEP surgery + Intravesical Botox Injections

Experimental group

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.

Treatment:

Drug: Intravesical Botox injection