Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality) (FIVES)

March 12, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult male patients born with classic bladder exstrophy or epipadias

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paternity rate
Time Frame: 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
Baseline (at first consultation)
Sperm quality
Time Frame: up to 2 months
concentration of mobile live sperm in semen analysis
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Etienne TERRIER, Doctor, Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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