NCT05319782

Brief Summary

The purpose of this study is to assess the long term urinary, sexual, cosmetic and psycho-social outcomes of adult patients operated for hypospadias during childhood

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

April 1, 2022

Last Update Submit

May 12, 2023

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

  • Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood

    Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood, assessed with flowmetry (maximal urinary flow)

    Day 1

Study Arms (1)

Experimental arm

EXPERIMENTAL
Other: Urethral stenosis assesment

Interventions

Urethral stenosis assesmentOTHER

Auto-questionnaires + Clinical examination + Flow metry and post-mictional residue

Experimental arm

Eligibility Criteria

Age18 Years - 23 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients operated for hypospadias during childhood (before the age of 15) at the University Hospital of Besançon (France)

You may not qualify if:

  • Patients with a non-operated hypospadias
  • Opposition to participate
  • Legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yann CHAUSSY, MD, PhD

    CHU De Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 8, 2022

Study Start

May 10, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

FR(1)