Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485453
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
Sponsor:
University of Gaziantep
Organization:
University of Gaziantep
Study Overview
Official Title:
Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Purpose To evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin A onaBoNT-A in patients with neurogenic lower urinary tract dysfunction NLUTD
Methods Patients with NLUTD who received 200 IU onaBont-A injections at Gaziantep University Faculty of Medicine Department of Urology between September 2013 and September 2023 were included in the study Urodynamic parameters including cystometric capacity detrusor pressure Pdet and compliance detrusor leak point pressure DLPP phasic or terminal neurogenic overactivity were assessed Additionally the correlations between these parameters and treatment outcomes were analyzed
Changes in the number of pads used per day due to UI were assessed every 3 months during the postoperative period The time lapsed to return to the pad usage levels before onaBoNT-A injections was recorded as the duration of the benefit
Preoperative urodynamic data of the patients were compared between groups Additionally a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy duration of benefit from treatment and urodynamic parameters
Methods Patients with NLUTD who received 200 IU onaBont-A injections at Gaziantep University Faculty of Medicine Department of Urology between September 2013 and September 2023 were included in the study Urodynamic parameters including cystometric capacity detrusor pressure Pdet and compliance detrusor leak point pressure DLPP phasic or terminal neurogenic overactivity were assessed Additionally the correlations between these parameters and treatment outcomes were analyzed
Changes in the number of pads used per day due to UI were assessed every 3 months during the postoperative period The time lapsed to return to the pad usage levels before onaBoNT-A injections was recorded as the duration of the benefit
Preoperative urodynamic data of the patients were compared between groups Additionally a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy duration of benefit from treatment and urodynamic parameters
Detailed Description:
None
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