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

NCT06485453 | Completed

• 1 other identifier: GAUN-Urology-Baturu-001
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurogenic Bladder Disorder

Keywords

Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

Botox 200 UNT Injection DRUG

Treatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged

Botulinum Toxin A non-responder; Botulinum Toxin A responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2013
• Primary Completion: September 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share