Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexu... | NCT02759705

Studies
Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

NCT02759705

Sponsor

Hospices Civils de Lyon

Status

Withdrawn

Last Update Posted

Mar 13, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Fertility

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no staff available to do the research

Expanded Access Info

Start Date

Sep 2017Estimated

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Apr 28, 2016

First Submission Date that Met QC Criteria

Apr 29, 2016

First Posted Date

May 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult male patients born with classic bladder exstrophy or epipadias

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Etienne TERRIER, Doctor	Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019529	Sexuality
D001746	Bladder Exstrophy
D004842	Epispadias

Ancestor Terms

ID	Term
D012725	Sexual Behavior
D001519	Behavior
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided