Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.
Condition: Bladder Exstrophy
MeSH terms: Bladder Exstrophy
Study type: Observational

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).
    


Intervention name(s): Self or straight administered questionnaire
Intervention type(s): Other
Intervention description(s): 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.
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.
      
Keywords: Bladder exstrophy; Quality of life; Urinary continence; Fecal continence