Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in Overactive Bladder Symptoms Score (OABSS)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males age > 40
- •Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) 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
排除标准
- •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
研究组 & 干预措施
Patients receiving Bipolar enucleation of the prostate surgery only
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.
干预措施: Bipolar enucleation of the prostate (BipolEP) (Procedure)
Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections
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.
干预措施: Bipolar enucleation of the prostate (BipolEP) (Procedure)
Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections
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.
干预措施: Intravesical Botox injection (Drug)
结局指标
主要结局
Change in Overactive Bladder Symptoms Score (OABSS)
时间窗: 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 Post-Void Residual (PVR) Volume
时间窗: 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
Change in International Prostate Symptom Score (IPSS)
时间窗: 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 Maximum Urinary Flow rate
时间窗: 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
次要结局
- Adverse events(Adverse events will be monitored throughout the entire study duration (6 months after the surgery))
研究者
Mohamed Kamal Omar
Prof.Dr
Menoufia University
