Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

NCT ID: NCT02759705

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-05-31

Brief Summary

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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

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Conditions

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Fertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Etienne TERRIER, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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69HCL16_0044

Identifier Type: -

Identifier Source: org_study_id

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