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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder Disorder
• Intervention / Treatment: Drug: Botox 200 UNT Injection

• Study Type: Observational
• Enrollment (Actual): 74

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Neurogenic Lower Urinary Tract Disorder who didn't respond to anticholinergic treatment were the goal population.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Botulinum Toxin A responder; Patients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1	Drug: Botox 200 UNT Injection; Treatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged
Botulinum Toxin A non-responder; Patients who did not respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 2	Drug: Botox 200 UNT Injection; Treatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Gaziantep

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Neurogenic; Urinary Bladder Diseases
• Other Study ID Numbers: GAUN-Urology-Baturu-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No