Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362083
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-08
Brief Title:
Urethral Stricture Database
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study
Detailed Description:
The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture In addition to pre-operative basic data intraoperative and postoperative data as well as follow-up data through questionnaires are to be collected The main objective is the prospective determination of success rates of the performed urethral surgeries in the short medium and long term Furthermore risk factors leading to failure recurrence of urethral stricture should be identified Ultimately the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures
In todays reconstructive urethral surgery there are few scientific surveys so far Many of the applied techniques therapy options are based more on the experiences of individual surgeons than on a solid database hence there are also different approaches By evaluating prospective data and comparing individually applied surgical methods the least complication-prone and most successful techniques are to be identified The planned study aims to create an efficacy-safety profile for each urethral surgery technique This will enable us in the future to not only provide improved data-based patient information but also to involve the patient better in the therapy decision Thus in the future counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active even with the same stricture length and location
The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling
In todays reconstructive urethral surgery there are few scientific surveys so far Many of the applied techniques therapy options are based more on the experiences of individual surgeons than on a solid database hence there are also different approaches By evaluating prospective data and comparing individually applied surgical methods the least complication-prone and most successful techniques are to be identified The planned study aims to create an efficacy-safety profile for each urethral surgery technique This will enable us in the future to not only provide improved data-based patient information but also to involve the patient better in the therapy decision Thus in the future counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active even with the same stricture length and location
The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None