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

NCT ID: NCT05690594

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-07-13

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).

Conditions

Bladder Exstrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Femme Mère Enfant

Bron, , France

Hôpital Femme mère et enfant

Bron, , France

Countries

France

Other Identifiers

69HCL22_1072

Identifier Type: -

Identifier Source: org_study_id