Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

NCT02759705 | Withdrawn

• 1 other identifier: 69HCL16_0044
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fertility

Keywords

fertility; sexuality; male; exstrophy-epispadias complex; bladder exstrophy; epispadias

Outcome Measures

Primary Outcomes (2)

• 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)

• Sperm quality

  concentration of mobile live sperm in semen analysis

  up to 2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients born with classic bladder exstrophy or epipadias

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Sexuality; Bladder Exstrophy; Epispadias

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urethral Diseases

Study Officials

• Jean-Etienne TERRIER, Doctor

  Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: September 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03