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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox 200 UNT Injection

Drug

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

Primary outcomes

Number of patients after onabotulinum a toxin injections who respond to treatment

Time frame: 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

treatment succes duration of patients

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2023
Study completion: 2024
First posted: Jul 3, 2024
Registry last updated: Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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