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WithdrawnNCT02759705FIVESUpdated Mar 13, 2019

Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

An observational study in Fertility, sponsored by Hospices Civils de Lyon. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Hospices Civils de Lyon · Observational

Why this study was withdrawn
no staff available to do the research
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Fertility

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Keywords

  • fertility
  • sexuality
  • male
  • exstrophy-epispadias complex
  • bladder exstrophy
  • epispadias
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In context

Sexuality

30 studies on the registry are indexed under Sexuality; 10 are open to participants now.

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Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult male patients born with classic bladder exstrophy or epipadias

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline (at first consultation)

  2. Sperm quality

    concentration of mobile live sperm in semen analysis

    Time frame: up to 2 months

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02759705
Responsible party
Sponsor
First posted
May 3, 2016
Start date
Sep 2017 (estimated)
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Mar 13, 2019

Study contacts

Jean-Etienne TERRIER, Doctor
principal investigator · Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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