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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).
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 Bipolar prostate enucleation (BipolEP) 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 BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar enucleation of the prostate (BipolEP) | Procedure | Bipolar enucleation of the prostate (BipolEP) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded | Adverse events will be monitored throughout the entire study duration (6 months after the surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Kamal Omar, MD | Contact | +20 106 694 9454 | Kimo_81eg@yahoo.com |
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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.
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| 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). |
|
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
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