Bladder CalculiMini-DUCCNCT07643454
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
An observational study of Bladder Calculi and Continent Catheterizable Urinary Reservoir, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Calculi, Continent Catheterizable Urinary Reservoir, Trans-Stomal Bladder Lithotripsy
- What is being tested?
- QoL-DUCC questionnaire and Qualiveen Questionnaire
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Oct 2026to 19 Feb 2027
- Phase
- Observational
- 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
Study population: Major patients with a continent cutaneous urinary diversion, followed in the urology departments of Lyon Sud Hospital and Édouard Herriot Hospital
Who may be able to join
- Adult patient (aged 18 years or older)
- Patient with a catheterizable continent urinary diversion
- History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024
- Patient has expressed non-opposition to participate in the research
Who cannot join
- Percutaneous or trans-stomal surgery for foreign body removal
- Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Nadia ABID, MD, PhD, +33 4 72 11 96 75, nadia.abid@chu-lyon.fr
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69495
Théo ARBER, MD, PhD, +33 472678813, theo.arber@chu-lyon.fr
About this study
The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations.
In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique.
Read more
At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment.
Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.
- Conditions
- Bladder Calculi, Continent Catheterizable Urinary Reservoir, Trans-Stomal Bladder Lithotripsy, Open Cystolithotomy
- Being tested
- QoL-DUCC questionnaire, Qualiveen Questionnaire
- Medical subject headings
- Urinary Bladder Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoL-DUCC questionnaireOther
Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Qualiveen QuestionnaireOther
Patients of all groups will answer this validated quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment | Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment Receives: Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire | |
| Trans-stomial bladder lithotripsy using flexible fibroscope | Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope Receives: Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire | |
| Percutaneous cystholithotripsy | Patient operated on using Percutaneous cystholithotripsy Receives: Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire | |
| Open Cystolithotomy | Patient operated on using Open Cystolithotomy Receives: Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual stone size greater than 4mm postoperatively.
Residual stone size greater than 4mm postoperatively will be investigated on imaging control
Measured: Up to 7 days after surgery
Secondary outcomes (2)
Qol-DUCC questionnaire answers
answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
Measured: At inclusion
Qualiveen questionnaire score
The Qualiveen questionnaire score will be analysed to assess patient quality of life, for individuals who have urinary disorders.
It contains 4 domains: Limitations/Inconvenience, Constraints/Restrictions, Fears, Feelings/Impact on Daily Life. The questionnaire is based on a 5-point Likert scale (0 = "not at all", 4 = "extremely"). Each domain score is calculated as an average of the scores for the domain items. An overall (averaged) score can also be calculated. Lower scores on this questionnaire indicate higher quality of life.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start19 Oct 2026
- Primary completion19 Feb 2027 (estimated)
- Study completion19 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CalculiStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia ABID, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643454
- Sponsor's protocol ID
- 69HCL26_0256
- Acronym
- Mini-DUCC
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07643454
- Acronym / sponsor ID
- Mini-DUCC / 69HCL26_0256
- Conditions
- Bladder Calculi, Continent Catheterizable Urinary Reservoir, Trans-Stomal Bladder Lithotripsy, Open Cystolithotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 19 Feb 2027 (estimated)
- First posted
- 11 Jun 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.
The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations.
In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique.
At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment.
Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment | – | Other: QoL-DUCC questionnaire, Other: Qualiveen QuestionnairePatient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment |
| Trans-stomial bladder lithotripsy using flexible fibroscope | – | Other: QoL-DUCC questionnaire, Other: Qualiveen QuestionnairePatient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope |
| Percutaneous cystholithotripsy | – | Other: QoL-DUCC questionnaire, Other: Qualiveen QuestionnairePatient operated on using Percutaneous cystholithotripsy |
| Open Cystolithotomy | – | Other: QoL-DUCC questionnaire, Other: Qualiveen QuestionnairePatient operated on using Open Cystolithotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients with a continent cutaneous urinary diversion, followed in the urology departments of Lyon Sud Hospital and Édouard Herriot Hospital
Key inclusion criteria (4 listed)
- Adult patient (aged 18 years or older)
- Patient with a catheterizable continent urinary diversion
- History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024
- Patient has expressed non-opposition to participate in the research
Key exclusion criteria (2 listed)
- Percutaneous or trans-stomal surgery for foreign body removal
- Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)
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 |
|---|---|---|
| QoL-DUCC questionnairePatients of all groups will answer this quality of life questionnaire that has been specially designed for the study | Other | Open Cystolithotomy, Percutaneous cystholithotripsy, Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment, Trans-stomial bladder lithotripsy using flexible fibroscope |
| Qualiveen QuestionnairePatients of all groups will answer this validated quality of life questionnaire | Other | Open Cystolithotomy, Percutaneous cystholithotripsy, Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment, Trans-stomial bladder lithotripsy using flexible fibroscope |
Primary outcome
Residual stone size greater than 4mm postoperatively.
Time frame: Up to 7 days after surgery
Residual stone size greater than 4mm postoperatively will be investigated on imaging control
2 secondary outcomes
Qol-DUCC questionnaire answers
Time frame: At inclusion
Qualiveen questionnaire score
Time frame: At inclusion
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nadia ABID, MD, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Calculi and Continent Catheterizable Urinary Reservoir, run by Hospices Civils de Lyon at 2 sites in France.
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 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nadia ABID, MD, PhD (+33 4 72 11 96 75, nadia.abid@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual stone size greater than 4mm postoperatively. (time frame: Up to 7 days after surgery). 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 26 Oct 2026.