Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02759705

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.

Condition or Disease	Intervention/Treatment	Phase
Fertility

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?

Anticipated Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Outcome Measures

Primary Outcome Measures

paternity rate [Baseline (at first consultation)]
paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses
Sperm quality [up to 2 months]
concentration of mobile live sperm in semen analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients followed the Hospices Civils de Lyon
Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology
Aged over 18 years
Born with classic bladder exstrophy or epispadias.