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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06485453
Enrollment
74
Registered
2024-07-03
Start date
2013-09-01
Completion date
2024-06-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Bladder Disorder

Keywords

Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics

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.

Interventions

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

Sponsors

University of Gaziantep
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients after onabotulinum a toxin injections who respond to treatmentreceived 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.

Secondary

MeasureTime frameDescription
treatment succes duration of patientsReceived 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026