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NCT Number: NCT07831486

Impact of Concomitant TURP on Bladder Stone Surgery Outcomes

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.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location status: Recruiting

Location contact

doaa mahmoud khalil, assistant professor

CONTACT

[email protected]

01152091011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transurethral Cystolitholapaxy Alone

Procedure

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 (TURP)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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),

  2. "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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Abdallah Mahmoud, lecturer of urology

CONTACT

[email protected]

01155361979

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

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.

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