Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Adult men aged 40 years or older.
- Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) \>= 8.
- 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.
Exclusion Criteria:
- 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).
