Clinical Trials Directory

Trials / Completed

CompletedNCT06485453

Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction

Status
Completed
Phase
Study type
Observational
Enrollment
74 (actual)
Sponsor
University of Gaziantep · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBotox 200 UNT InjectionTreatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged

Timeline

Start date
2013-09-01
Primary completion
2023-09-01
Completion
2024-06-01
First posted
2024-07-03
Last updated
2024-07-03

Source: ClinicalTrials.gov record NCT06485453. Inclusion in this directory is not an endorsement.