Faculty of Medicine, Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62511, Egypt
Location status: Recruiting
NCT Number: NCT07831486
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.
Interested in participating?
Request Info40 year and older
Male
Interventional
Not applicable
Banī Suwayf, Beni Suweif Governorate, 62511, Egypt
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
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
Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL/s
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Post-void residual urine volume (PVR) assessed by ultrasonography.
Contact information is provided by the study sponsor or research team.
Beni-Suef University
Other
Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07642440
Bladder Stone, Calculi
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT06970587
Bladder Stone, Calculi
Qina, Egypt
View Trial DetailsNCT07623980
Bladder Calculi, Calculi
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT07614880
Bladder Calculi, Calculi
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial Details