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

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.

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 Overview

• Status: Completed
• Conditions: Bladder Exstrophy
• Intervention / Treatment: Other: Self or straight administered questionnaire

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Femme Mère Enfant
  • Bron, France
    • Hôpital Femme Mère et enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At inclusion
Assessment of FLQI score for fecal continence	- Mean FLQI score for fecal continence	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	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.	At inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Urinary continence; Bladder exstrophy; Fecal continence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urogenital Abnormalities; Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bladder Exstrophy
• Other Study ID Numbers: 69HCL22_1072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No