Bladder ExstrophyQUALEXSTRONCT05690594
Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.
An observational study of Bladder Exstrophy, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
The bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Bladder Exstrophy
- What is being tested?
- Self or straight administered questionnaire
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Apr 2023to 13 Jul 2023
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population is selected on the database of the hospital. All patients over 15 years old and treated for bladder exstrophy or cloacal exstrophy at our institution are included in the study.
Who may be able to join
- Patients born with bladder exstrophy or cloacal exstrophy
- Aged 15 and over at time of enrolment
- Treated at the Hospices Civils of Lyon
Who cannot join
- patients treated for epispadias
- patients initially treated of their bladder exstrophy abroad with no access to the surgical report
- patients under a guardianship measure
- deceased patients
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Femme Mère Enfant
Bron, 69500
Hôpital Femme mère et enfant
Bron
About this study
Official title: Evaluation of Long-term Outcomes on Urinary Continence, Fecal Continence, Sexuality and Quality of Life of Patients Treated for Bladder Exstrophy by Questionnaires.
The bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable continence and a normal sexual function at adulthood. Despite the surgeries, patients may suffer, in the long term, from functional impairments (incontinence, sexuality disorders) which can impact severely their quality of life. However, only a few studies investigate long term issues of bladder exstrophy patients, with heterogenous population and small samples.
The department of pediatric surgery of the Hospices Civils of Lyon is an expert center in the management of patients born with bladder exstrophy. At adulthood, departments of adult urology continue the follow-up and treat residual complications. Thus, a large cohort of adults and adolescents' patients with bladder exstrophy is currently followed at our institution.
Read more
Therefore, the aim of this study is to evaluate urinary continence, fecal continence, sexuality and quality of life among a large cohort of patients treated for bladder exstrophy, using questionnaires.
All patients over 15 years old and treated for bladder exstrophy at our institution are included in the study. Exclusion's criteria are : patients treated for epispadias or cloacal exstrophy, patients initially treated of their bladder exstrophy abroad with no access to the surgical report, patients under a guardianship measure. All included patients are contacted by e-mail or phone to answer the questionnaire. The purpose of statistical analysis is to evaluate the average score in each field of investigation:
- Mean ICIQ score for urinary continence
- Mean FLQI score for fecal continence
- Mean FSFI score for sexuality in women
- Mean IIEF-5 score for sexuality in men
- Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature
Secondary objectives are to assess the impact of different surgical strategies used for bladder exstrophy reparation on urinary continence, fecal continence, sexuality and quality of life ; to describe the population from a sociological point of view (level of study, profession, marital status) and to describe the population reproductive status (pregnancy, delivery modalities, paternity and maternity status, use of medically assisted procreation).
- Conditions
- Bladder Exstrophy
- Being tested
- Self or straight administered questionnaire
- Keywords
- Bladder exstrophy, Quality of life, Urinary continence, Fecal continence
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self or straight administered questionnaireOther
Self or straight administered questionnaire with 5 parts:
- General questionnaire (to collect socio-demographic data)
- ICIQ score to evaluate urinary continence
- FLQI score to evaluate fecal continence
- FSFI score to evaluate sexuality in women or IIEF-5 score to evaluate sexuality in men
- SF-12 score to evaluate quality of life The questionnaire will be sent to patients by email and/or mail. Patients will be able to either complete the questionnaire alone and return it to the primary investigator, or to request a telephone interview to help them to complete the questionnaire. The questionnaire is administered only once and the estimated response time to the questionnaire is between 30 minutes and one hour.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of average score of ICIQ score for urinary continence
The study is descriptive, and the purpose is to evaluate the average score in each field of investigation:
- Mean ICIQ score for urinary continence
Measured: At inclusion
Assessment of FLQI score for fecal continence
- Mean FLQI score for fecal continence
Measured: At inclusion
Assessment of FSFI score and IIEF-5 score for sexuality in women and men
- Mean FSFI score for sexuality in women
- Mean IIEF-5 score for sexuality in men
Measured: At inclusion
Assessment of SF-12 score for quality of life
- Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature.
Data on the average SF-12 score for the French population are available in the Gandek et al study, which validated the French version of the score in 1998.
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 posted19 Jan 2023
- Study start20 Apr 2023
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExstrophyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690594
- Sponsor's protocol ID
- 69HCL22_1072
- Acronym
- QUALEXSTRO
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2023
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Outcomes on Urinary Continence, Fecal Continence, Sexuality and Quality of Life of Patients Treated for Bladder Exstrophy by Questionnaires.
- ClinicalTrials.gov ID
- NCT05690594
- Acronym / sponsor ID
- QUALEXSTRO / 69HCL22_1072
- Conditions
- Bladder Exstrophy
- Keywords
- Bladder exstrophy, Quality of life, Urinary continence, Fecal continence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 19 Jan 2023 (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 bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable continence and a normal sexual function at adulthood. Despite the surgeries, patients may suffer, in the long term, from functional impairments (incontinence, sexuality disorders) which can impact severely their quality of life. However, only a few studies investigate long term issues of bladder exstrophy patients, with heterogenous population and small samples.
The department of pediatric surgery of the Hospices Civils of Lyon is an expert center in the management of patients born with bladder exstrophy. At adulthood, departments of adult urology continue the follow-up and treat residual complications. Thus, a large cohort of adults and adolescents' patients with bladder exstrophy is currently followed at our institution.
Therefore, the aim of this study is to evaluate urinary continence, fecal continence, sexuality and quality of life among a large cohort of patients treated for bladder exstrophy, using questionnaires.
All patients over 15 years old and treated for bladder exstrophy at our institution are included in the study. Exclusion's criteria are : patients treated for epispadias or cloacal exstrophy, patients initially treated of their bladder exstrophy abroad with no access to the surgical report, patients under a guardianship measure. All included patients are contacted by e-mail or phone to answer the questionnaire. The purpose of statistical analysis is to evaluate the average score in each field of investigation:
- Mean ICIQ score for urinary continence
- Mean FLQI score for fecal continence
- Mean FSFI score for sexuality in women
- Mean IIEF-5 score for sexuality in men
- Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature
Secondary objectives are to assess the impact of different surgical strategies used for bladder exstrophy reparation on urinary continence, fecal continence, sexuality and quality of life ; to describe the population from a sociological point of view (level of study, profession, marital status) and to describe the population reproductive status (pregnancy, delivery modalities, paternity and maternity status, use of medically assisted procreation).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population is selected on the database of the hospital. All patients over 15 years old and treated for bladder exstrophy or cloacal exstrophy at our institution are included in the study.
Key inclusion criteria (3 listed)
- Patients born with bladder exstrophy or cloacal exstrophy
- Aged 15 and over at time of enrolment
- Treated at the Hospices Civils of Lyon
Key exclusion criteria (4 listed)
- patients treated for epispadias
- patients initially treated of their bladder exstrophy abroad with no access to the surgical report
- patients under a guardianship measure
- deceased patients
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 |
|---|---|---|
| Self or straight administered questionnaireSelf or straight administered questionnaire with 5 parts: * General questionnaire (to collect socio-demographic data) * ICIQ score to evaluate urinary continence * FLQI score to evaluate fecal continence * FSFI score to evaluate sexuality in women or IIEF-5 score to evaluate sexuality in men * SF-12 score to evaluate quality of life The questionnaire will be sent to patients by email and/or mail. Patients will be able to either complete the questionnaire alone and return it to the primary investigator, or to request a telephone interview to help them to complete the questionnaire. The questionnaire is administered only once and the estimated response time to the questionnaire is between 30 minutes and one hour. | Other | – |
Primary outcome
Assessment of average score of ICIQ score for urinary continence
Time frame: At inclusion
The study is descriptive, and the purpose is to evaluate the average score in each field of investigation: - Mean ICIQ score for urinary continence
Assessment of FLQI score for fecal continence
Time frame: At inclusion
- Mean FLQI score for fecal continence
Assessment of FSFI score and IIEF-5 score for sexuality in women and men
Time frame: At inclusion
* Mean FSFI score for sexuality in women * Mean IIEF-5 score for sexuality in men
Assessment of SF-12 score for quality of life
Time frame: At inclusion
- Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature. Data on the average SF-12 score for the French population are available in the Gandek et al study, which validated the French version of the score in 1998.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exstrophy, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of average score of ICIQ score for urinary continence (time frame: At inclusion). The study lists 4 primary outcomes in all. 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 7 Sep 2023.