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

University of Gaziantep

Status: Completed

Conditions: Neurogenic Bladder Disorder

Treatments: Drug: Botox 200 UNT Injection

Study type: Observational

Funder types: Other

Identifiers

NCT06485453

GAUN-Urology-Baturu-001

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

74 participants in 2 patient groups

Botulinum Toxin A responder

Description:

Patients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1

Treatment:

Drug: Botox 200 UNT Injection

Botulinum Toxin A non-responder

Description:

Patients who did not respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 2

Treatment:

Drug: Botox 200 UNT Injection