Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

Withdrawn

• Conditions: Fertility

• Registration Number: NCT02759705
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Study Start: 2017-09
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Read More

Exclusion Criteria

• Refusal of participation
• Refusal to sign consent
• minor Patients or protected major, under guardianship
• Patients unable to understand the course of the study
• cloacal exstrophy

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sperm quality	up to 2 months	concentration of mobile live sperm in semen analysis
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