Clinical trial NCT05690594: Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Exstrophy
Keywords: Bladder exstrophy
Quality of life
Urinary continence
Fecal continence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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).


Eligibility criteria: Inclusion Criteria:

* Patients born with bladder exstrophy or cloacal exstrophy
* Aged 15 and over at time of enrolment
* Treated at the Hospices Civils of Lyon

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of average score of ICIQ score for urinary continence
timeFrame: At inclusion
measure: Assessment of FLQI score for fecal continence
timeFrame: At inclusion
measure: Assessment of FSFI score and IIEF-5 score for sexuality in women and men
timeFrame: At inclusion
measure: Assessment of SF-12 score for quality of life
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Bron
country: France
facility: Hôpital Femme mère et enfant
Study officials:
References: