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Impact of Concomitant TURP on Bladder Stone Surgery Outcomes

ConditionBladder Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Evidence or history of urethral stricture.

Known or suspected prostate cancer.

Known or suspected bladder cancer / urothelial malignancy.

Neurogenic bladder dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transurethral Cystolitholapaxy Alone

    Procedure/Surgery

    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/Surgery

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

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Cystolitholapaxy AloneActive comparator 1 intervention
Group B: Cystolitholapaxy + Concomitant TURPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-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

Secondary outcomes

1

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
2

"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
3

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

Other outcomes

Sponsors and contacts

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Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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