Transurethral Versus Percutaneous Cystolithotripsy for Bladder Stones in Adults

ConditionsUrinary Bladder Calculi Bladder Calculi Urolithiasis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

This study evaluates and compares two minimally invasive surgical approaches for treating bladder stones in adult patients: transurethral cystolithotripsy (TUCL) and percutaneous cystolithotripsy (PCCL).

Urinary bladder stones are commonly managed using endoscopic techniques to avoid the morbidity of open surgery. TUCL accesses the bladder through the natural urinary channel (urethra), whereas PCCL accesses the bladder directly through a small puncture in the lower abdomen above the pubic bone. While both approaches are effective, comparative data in adult populations remain limited.

Eligible participants are randomly assigned to receive either TUCL or PCCL. The primary goal is to compare stone clearance rates and operative times between the two procedures. Secondary objectives include comparing surgical complication rates, duration of postoperative urinary catheterization, and length of hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 years or older

Diagnosed with single or multiple urinary bladder stones

Stone diameter between 1 and 4 cm at its largest diameter or cumulative stone diameter

Candidates for both transurethral and percutaneous endoscopic treatment modalities

Disqualifiers

Active urinary tract infection (UTI)

Uncorrected coagulopathy or bleeding disorders

Known urethral stricture or significant urethral pathology precluding safe transurethral instrumentation

History of bladder augmentation, major lower abdominal surgery, or pelvic radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

Transurethral Cystolithotripsy
Procedure/Surgery
Under spinal or general anesthesia, a rigid cystoscope is introduced transurethrally under direct vision. Bladder calculi are visualized and fragmented using a Mauermayer stone punch and/or pneumatic lithotripter via a semirigid ureteroscope according to stone size and consistency. Stone fragments are evacuated using an Ellik evacuator and/or grasping forceps. Complete clearance and mucosal integrity are confirmed by cystoscopy, followed by insertion of a two-way urethral Foley catheter.
Percutaneous Cystolithotripsy
Procedure/Surgery
Under spinal or general anesthesia, the bladder is distended retrogradely with 300-400 cc sterile irrigation fluid via cystoscopy. Under combined ultrasound and cystoscopic guidance, a midline suprapubic percutaneous puncture is executed using an 18G needle, followed by guidewire placement, tract dilation, and insertion of a 30 F Amplatz working sheath. A 26 F rigid nephroscope is introduced, and calculi are fragmented using a pneumatic lithotripter and removed with grasping forceps. A urethral Foley catheter is placed postoperatively, with or without a suprapubic tube based on intraoperative findings.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Group A: Transurethral Cystolithotripsy (TUCL)Active comparator 1 intervention

Group B: Group B: Percutaneous Cystolithotripsy (PCCL)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Stone-Free Rate

Stone-free status is defined as complete stone clearance or presence of clinically insignificant residual fragments (CIRF) \<= 2 mm confirmed by direct endoscopic inspection.

Time frame

1 day

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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