Urinary Bladder CalculiNCT07810582
Transurethral Versus Percutaneous Cystolithotripsy for Bladder Stones in Adults
A study testing Transurethral Cystolithotripsy and Percutaneous Cystolithotripsy in people with Urinary Bladder Calculi and Bladder Calculi, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Calculi, Bladder Calculi, Urolithiasis
- What is being tested?
- Transurethral Cystolithotripsy and Percutaneous Cystolithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Transurethral Versus Percutaneous Cystolithotripsy for the Management of Bladder Stones in Adults: A Prospective Randomized Comparative Study
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
- Being tested
- Transurethral Cystolithotripsy, Percutaneous Cystolithotripsy
- Keywords
- Transurethral Cystolithotripsy, Percutaneous Cystolithotripsy, TUCL, PCCL, Lithotripsy, Bladder Stones
- Medical subject headings
- Urinary Bladder Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral CystolithotripsyProcedure or 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 CystolithotripsyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Percutaneous Cystolithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CalculiStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Ahmed Aboliela, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810582
- Sponsor's protocol ID
- TUCL vs PCCL for Bladder Stone
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Versus Percutaneous Cystolithotripsy for the Management of Bladder Stones in Adults: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07810582
- Acronym / sponsor ID
- TUCL vs PCCL for Bladder Stone
- Conditions
- Urinary Bladder Calculi, Bladder Calculi, Urolithiasis
- Keywords
- Transurethral Cystolithotripsy, Percutaneous Cystolithotripsy, TUCL, PCCL, Lithotripsy, Bladder Stones
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Transurethral Cystolithotripsy (TUCL) | Active comparator | Procedure: Transurethral CystolithotripsyParticipants 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. |
| Group B: Percutaneous Cystolithotripsy (PCCL) | Active comparator | Procedure: Percutaneous CystolithotripsyParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transurethral CystolithotripsyUnder 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. | Procedure or surgery | Group A: Transurethral Cystolithotripsy (TUCL) |
| Percutaneous CystolithotripsyUnder 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. | Procedure or surgery | Group B: Percutaneous Cystolithotripsy (PCCL) |
Primary outcome
Stone-Free Rate
Time frame: 1 day
Stone-free status is defined as complete stone clearance or presence of clinically insignificant residual fragments (CIRF) <= 2 mm confirmed by direct endoscopic inspection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Related trials for Urinary Bladder Calculi
RecruitingObservational study
Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir
Bladder Calculi, Continent Catheterizable Urinary Reservoir
Recruiting
Impact of Concomitant TURP on Bladder Stone Surgery Outcomes
Bladder Stone
RecruitingObservational study
Development of an AI-Agent for Urological Disease Diagnosis and Treatment
Urinary Stones, Prostate Cancer
Recruiting
Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones
Bladder Stone, Cystolithiasis
Recruiting
Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
Bladder Calculi, Pediatric Bladder Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Cystolithotripsy and Percutaneous Cystolithotripsy in people with Urinary Bladder Calculi and Bladder Calculi, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.