Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.

Completed

• Conditions: Bladder Exstrophy

• Registration Number: NCT05690594
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-19
• Study Start: 2023-04-20
• Primary Completion: 2023-07-13
• Study Completion: 2023-07-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of average score of ICIQ score for urinary continence	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 FSFI score and IIEF-5 score for sexuality in women and men	At inclusion	* Mean FSFI score for sexuality in women; * Mean IIEF-5 score for sexuality in men
Assessment of FLQI score for fecal continence	At inclusion	- Mean FLQI score for fecal continence
Assessment of SF-12 score for quality of life	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.

Trial Locations

Locations (2)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Hôpital Femme mère et enfant; 🇫🇷 Bron, France