Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

Fertility Clinical Trial

— FIVES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02759705
• Other study ID #: 69HCL16_0044
• Status: Withdrawn
• Start date: September 2017
• Est. completion date: May 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Bladder Exstrophy
• Fertility

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	paternity rate	paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses	Baseline (at first consultation)
Primary	Sperm quality	concentration of mobile live sperm in semen analysis	up to 2 months