Back to resultsLong-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences (SAHARA)
Primary Purpose
Hypospadias
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urethral stenosis assesment
Sponsored by
About this trial
This is an interventional other trial for Hypospadias
Eligibility Criteria
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
Sites / Locations
- CHU de BesançonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05319782
First Posted
April 1, 2022
Last Updated
May 12, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT05319782
Brief Title
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences
Acronym
SAHARA
Official Title
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Urethral stenosis assesment
Intervention Description
Auto-questionnaires + Clinical examination + Flow metry and post-mictional residue
Primary Outcome Measure Information:
Title
Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood
Description
Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood, assessed with flowmetry (maximal urinary flow)
Time Frame
Day 1
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann CHAUSSY, MD, PhD
Organizational Affiliation
CHU De Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann CHAUSSY, MD, PhD
Phone
0033381219400
Email
ychaussy@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Yann CHAUSSY, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences
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