Clinical trial NCT06485453: Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
Official title: Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder Disorder
Keywords: Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients after onabotulinum a toxin injections who respond to treatment
timeFrame: 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:
measure: treatment succes duration of patients
timeFrame: Received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.
Other outcomes:
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