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

Bladder Exstrophy Clinical Trial

— QUALEXSTRO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690594
• Other study ID #: 69HCL22_1072
• Status: Completed
• Start date: April 20, 2023
• Est. completion date: July 13, 2023

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Exstrophy

Intervention

Other:
• Self or straight administered questionnaire
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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron
France	Hôpital Femme mère et enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assessment of FLQI score for fecal continence	- Mean FLQI score for fecal continence	At inclusion
Primary	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
Primary	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