Impact of Concomitant TURP on Bladder Stone Surgery Outcomes

September 16, 2026 updated by: Mahmoud Abdallah, Beni-Suef University

Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
        • Recruiting
        • Faculty of Medicine, Beni-Suef University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Transurethral Cystolitholapaxy Alone

Transurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery.
Experimental: Cystolitholapaxy + Concomitant TURP

Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting.
Procedure: Transurethral Resection of the Prostate (TURP)

Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-Free Rate (SFR)
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.
4 to 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)
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),
Baseline, 1 month, 3 months, and 6 months postoperatively
"Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)
Time Frame: Baseline, 1 month, 3 months, and 6 months postoperatively

Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL/s
Baseline, 1 month, 3 months, and 6 months postoperatively
Change in Post-Void Residual Urine Volume (PVR)
Time Frame: Baseline, 1 month, 3 months, and 6 months postoperatively

Post-void residual urine volume (PVR) assessed by ultrasonography.
Baseline, 1 month, 3 months, and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

September 12, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/05052026/Abdel-Azeem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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