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.
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). Follow-up evaluations are conducted at 1 month, 3 months, and 6 months postoperatively to assess the stone-free rate (SFR), stone recurrence rate, functional outcomes (IPSS, Qmax, PVR), and postoperative adverse events graded by the Clavien-Dindo classification system. Patients in Group 1 will be specifically monitored to identify independent risk factors necessitating delayed TURP during the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Transurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery.
Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy.
Faculty of Medicine, Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, Egypt
RECRUITINGStone-Free Rate (SFR)
Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray \[KUB\]) for all patients.
Time frame: 4 to 6 weeks postoperatively
Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)
Evaluation of urinary symptoms and voiding parameters including International Prostate Symptom Score (IPSS, range 0-35),
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
"Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)
Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL/s
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Change in Post-Void Residual Urine Volume (PVR)
Post-void residual urine volume (PVR) assessed by ultrasonography.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
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