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

Completed

• Conditions: Neurogenic Bladder Disorder
• Interventions: Drug: Botox 200 UNT Injection

• Registration Number: NCT06485453
• Lead Sponsor: University of Gaziantep

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2023-09-01
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-29
• Last Update Submitted: 2024-06-29
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients with Neurogenic Lower Urinary Tract Disorder
• Aged >18 years
• Patients who did not respond adequatel to antimuscarinics or could not tolerate their side effects
• Antimuscarinic treatment failure with at least two different antimuscarinic agents for a minimum of 3 months.

Exclusion Criteria

• Patients with Lower Urinary Tract Disorder due to functional or non-neurogenic etiologies
• Patients who received onaBoNT-A doses either other than 200 IU or its multiple doses
• In the 12-month period designated for patient follow-up, patients who did not attend their check-ups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin A responder	Botox 200 UNT Injection	Patients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1
Botulinum Toxin A non-responder	Botox 200 UNT Injection	Patients who did not respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 2

Primary Outcome Measures

Name	Time	Method
Number of patients after onabotulinum a toxin injections who respond to treatment	received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.

Secondary Outcome Measures

Name	Time	Method
treatment succes duration of patients	Received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.	The duration of the decrease in the number of pads used was calculated