SAHARA: Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences
Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05319782
Collaborator
(none)
66
1
12
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences
Anticipated Study Start Date
:
Apr 1, 2022
Anticipated Primary Completion Date
:
Apr 1, 2023
Anticipated Study Completion Date
:
Apr 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental arm
|
Other: Urethral stenosis assesment
Auto-questionnaires + Clinical examination + Flow metry and post-mictional residue
|
Outcome Measures
Primary Outcome Measures
- Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood [Day 1]
Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood, assessed with flowmetry (maximal urinary flow)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 23 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients operated for hypospadias during childhood (before the age of 15) at the University Hospital of Besançon (France)
Exclusion Criteria:
-
Patients with a non-operated hypospadias
-
Opposition to participate
-
Legal incapacity
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
- Principal Investigator: Yann CHAUSSY, MD, PhD, CHU De Besançon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT05319782
Other Study ID Numbers:
- 2021/663
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: