Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Stone-Free Rate (SFR)
研究概览
简要总结
The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively.
The primary objective of this prospective randomized comparative study is to compare the postoperative outcomes of cystolitholapaxy alone versus cystolitholapaxy with concomitant TURP in adult male patients presenting with bladder calculi secondary to BPH. Additionally, the study aims to identify clinical and urodynamic predictors for requiring subsequent (delayed) TURP among patients initially treated with stone surgery alone.
详细描述
Urinary bladder calculi represent approximately 5% of all urinary calculi, with secondary stones constituting the vast majority (>95%) of cases in adult men, predominantly secondary to bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH).
While current guidelines debate the necessity of routine concomitant outlet obstruction relief at initial stone surgery, evidence remains needed regarding single-stage versus selective staged treatment.
This prospective, randomized, single-center study will be conducted at the Urology Department, Beni-Suef University. A total of 104 eligible male patients aged 40 years or older with symptomatic BPH (IPSS >= 8, prostate size >= 30g, Qmax <= 15 ml/s) and imaging-confirmed bladder calculus/calculi will be randomly allocated (1:1 allocation using computer-generated block randomization) into one of two parallel groups:
- Group 1: Managed with transurethral cystolitholapaxy alone.
- Group 2: Managed with transurethral cystolitholapaxy with concomitant TURP.
All participants undergo comprehensive preoperative evaluation including medical history, International Prostate Symptom Score (IPSS), total and free PSA, urine analysis and culture, abdominopelvic ultrasound (assessing stone dimensions, prostate volume, post-void residual urine [PVR]), and uroflowmetry (Qmax).
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
- Single (Outcomes Assessor)
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
- •Adult men aged 40 years or older.
- •Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
- •International Prostate Symptom Score (IPSS) >=
- •Prostate size >= 30 grams (measured by ultrasonography).
- •Maximum urinary flow rate (Qmax) <= 15 mL/s.
- •Presence of urinary bladder calculus/calculi confirmed by diagnostic imaging.
- •Written informed consent provided prior to study enrollment.
排除标准
- •Evidence or history of urethral stricture.
- •Known or suspected prostate cancer.
- •Known or suspected bladder cancer / urothelial malignancy.
- •Neurogenic bladder dysfunction.
- •Chronic urinary retention with overflow incontinence.
- •Previous prostate or bladder neck surgery (e.g., prior TURP, TUIP, open prostatectomy).
- •Active urinary tract infection (UTI) at the time of surgery (patients treated for infection preoperatively may be reassessed for eligibility).
研究组 & 干预措施
Cystolitholapaxy Alone
Patients undergo transurethral cystolitholapaxy alone to clear bladder calculi, followed by conservative medical management of BPH and follow-up to evaluate the need for subsequent delayed TURP.
干预措施: Transurethral Cystolitholapaxy Alone (Procedure)
Cystolitholapaxy + Concomitant TURP
Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting.
干预措施: Transurethral Resection of the Prostate (TURP) (Procedure)
结局指标
主要结局
Stone-Free Rate (SFR)
时间窗: 4 to 6 weeks postoperatively
Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray \[KUB\]) for all patients.
次要结局
- Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)(Baseline, 1 month, 3 months, and 6 months postoperatively)
- "Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)(Baseline, 1 month, 3 months, and 6 months postoperatively)
- Change in Post-Void Residual Urine Volume (PVR)(Baseline, 1 month, 3 months, and 6 months postoperatively)
研究者
Mahmoud Abdallah
lecturer of urology
Beni-Suef University