Transurethral Versus Percutaneous Cystolithotripsy for Bladder Stones in Adults

NCT07810582 | Not Yet Recruiting

• 1 other identifier: TUCL vs PCCL for Bladder Stone
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Bladder Calculi; Bladder Calculi; Urolithiasis

Keywords

Transurethral Cystolithotripsy; Percutaneous Cystolithotripsy; TUCL; PCCL; Lithotripsy; Bladder Stones

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (2)

Group A: Transurethral Cystolithotripsy (TUCL)

ACTIVE COMPARATOR

Participants undergo transurethral cystolithotripsy under spinal or general anesthesia. A rigid cystoscope is introduced through the urethra under direct vision. Bladder calculi are visualized and fragmented using a Mauermayer stone punch and/or pneumatic lithotripter via a semirigid ureteroscope. Stone fragments are evacuated using an Ellik evacuator and/or grasping forceps. Stone clearance and mucosal integrity are confirmed by cystoscopy, followed by insertion of a two-way urethral Foley catheter.

Procedure: Transurethral Cystolithotripsy

Group B: Percutaneous Cystolithotripsy (PCCL)

ACTIVE COMPARATOR

Participants undergo percutaneous cystolithotripsy under spinal or general anesthesia. The bladder is filled retrogradely with 300-400 cc of sterile irrigation fluid via cystoscopy. Under ultrasound and cystoscopic guidance, a midline suprapubic puncture is performed with an 18G needle, followed by guidewire insertion, fascial dilation, and placement of a 30 F Amplatz sheath. Stones are fragmented with a pneumatic lithotripter via a 26 F nephroscope and extracted with grasping forceps. Postoperative drainage includes a urethral Foley catheter (with or without a suprapubic catheter).

Procedure: Percutaneous Cystolithotripsy

Interventions

Transurethral Cystolithotripsy PROCEDURE

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.

Group A: Transurethral Cystolithotripsy (TUCL)

Percutaneous Cystolithotripsy PROCEDURE

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.

Group B: Percutaneous Cystolithotripsy (PCCL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concomitant bladder tumor or suspected bladder neoplasm
• Stone located within a bladder diverticulum or within a contracted bladder
• Requiring concomitant urological procedures during the same operative session (e.g., transurethral resection of the prostate \[TURP\] or lower ureteric stone extraction)
• Urethral stones pushed back into the bladder
• Refusal to participate in the study

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Urinary Bladder Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09