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CompletedNCT06485453Updated Jul 3, 2024

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

An observational study in Neurogenic Bladder Disorder, sponsored by University of Gaziantep. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by University of Gaziantep · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
74
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neurogenic Bladder Disorder

Keywords

  • Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics
03

In context

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's enrollment of 74 is close to the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  1. treatment succes duration of patients

    The duration of the decrease in the number of pads used was calculated

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2013 to primary completion in Sep 2023, 120 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2024
First posted
Jul 3, 2024
StartActual
Sep 1, 2013
Primary completionActual
Sep 1, 2023
CompletionActual
Jun 1, 2024
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06485453
Responsible party
Muharrem Baturu (Assistant Proffesor, University of Gaziantep) — Principal investigator
First posted
Jul 3, 2024
Start date
Sep 1, 2013
Primary completion
Sep 1, 2023
Completion
Jun 1, 2024
Last update
Jul 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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