Neurogenic BladderICODENCT04922437
Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?
An observational study of Neurogenic Bladder and Continent Cutaneous Urinary Diversion, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty. METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurogenic Bladder, Continent Cutaneous Urinary Diversion, Mitrofanoff
- What is being tested?
- Native bladder implantation and Enterocystoplasty implantation
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric population recruited in the pediatric surgery and urology departments of Nancy University Hospital. Patients with congenital or acquired neurological bladder or malformative uropathies. Surgery performed between 1991 and 2020, followed in the long term in iterative consultation or in hospitalization for evaluation of continence and postoperative complications with or without surgical revision
Who may be able to join
- Adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel
- Between 1991 and 2020
- In the pediatric surgery or urology department at Nancy University Hospital
Who cannot join
- Ghoneim technique used for implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients
PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.
METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).
Read the detailed description
This is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a CCC between June 1991 and January 2020. Two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (D group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (EC group).
The CCC were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. Bladder augmentation and cervicoplasty (Kropp, Kurzrock, Young-Dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated.
The following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.
- Being tested
- Native bladder implantation, Enterocystoplasty implantation
- Keywords
- native bladder, enterocystoplasty, continent catheterizable channel, neurogenic bladder
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native bladder implantationProcedure or surgery
Continent catheterizable channel implanted in the detrusor of the native bladder
Enterocystoplasty implantationProcedure or surgery
Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation
| Study group | Role | What they receive |
|---|---|---|
| Enterocystoplasty (EC) | Patients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation. Receives: Procedure: Enterocystoplasty implantation | |
| Detrusor (D) | Patients who had an implantation of the catheterizable continent channel in the detruosr of their native bladder (Lich-Gregoir or Cohen). Receives: Procedure: Native bladder implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the long term continence between the two groups
Continence of the channel at last followup : as being strictly dry day and night between clean intermittent catheterizations (CIC). Patients requirring at leat one pad for leaking and also those with leaks wetting their clothes were considered incontinent as well as those whose interval between CIC was strictly less than 3 hours.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre LECOANET, Central Hospital, Nancy, France
- Investigators
- Pierre Lecoanet, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922437
- Sponsor's protocol ID
- 2020PI311
- Acronym
- ICODE
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients
- ClinicalTrials.gov ID
- NCT04922437
- Acronym / sponsor ID
- ICODE / 2020PI311
- Keywords
- native bladder, enterocystoplasty, continent catheterizable channel, neurogenic bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Jun 2021 (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.
PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.
METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).
Detailed description
This is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a CCC between June 1991 and January 2020. Two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (D group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (EC group).
The CCC were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. Bladder augmentation and cervicoplasty (Kropp, Kurzrock, Young-Dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated.
The following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enterocystoplasty (EC) | – | Procedure: Enterocystoplasty implantationPatients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation. |
| Detrusor (D) | – | Procedure: Native bladder implantationPatients who had an implantation of the catheterizable continent channel in the detruosr of their native bladder (Lich-Gregoir or Cohen). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric population recruited in the pediatric surgery and urology departments of Nancy University Hospital. Patients with congenital or acquired neurological bladder or malformative uropathies. Surgery performed between 1991 and 2020, followed in the long term in iterative consultation or in hospitalization for evaluation of continence and postoperative complications with or without surgical revision
Key inclusion criteria (3 listed)
- Adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel
- Between 1991 and 2020
- In the pediatric surgery or urology department at Nancy University Hospital
Key exclusion criteria (1 listed)
- Ghoneim technique used for implantation
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 |
|---|---|---|
| Native bladder implantationContinent catheterizable channel implanted in the detrusor of the native bladder | Procedure or surgery | Detrusor (D) |
| Enterocystoplasty implantationContinent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation | Procedure or surgery | Enterocystoplasty (EC) |
Primary outcome
Comparison of the long term continence between the two groups
Time frame: 1 year
Continence of the channel at last followup : as being strictly dry day and night between clean intermittent catheterizations (CIC). Patients requirring at leat one pad for leaking and also those with leaks wetting their clothes were considered incontinent as well as those whose interval between CIC was strictly less than 3 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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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. This study is not recruiting at the moment.
Pierre Lecoanet principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder and Continent Cutaneous Urinary Diversion, run by Central Hospital, Nancy, France at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Comparison of the long term continence between the two groups (time frame: 1 year). 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 10 Jun 2021.