Neurogenic Bladder DisorderNCT06485453
Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
An observational study of Neurogenic Bladder Disorder, run by University of Gaziantep.
Trial summary
Purpose: To evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin A (onaBoNT-A) in patients with neurogenic lower urinary tract dysfunction (NLUTD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Disorder
- What is being tested?
- Botox 200 UNT Injection
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Neurogenic Lower Urinary Tract Disorder who didn't respond to anticholinergic treatment were the goal population.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read more
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
- Being tested
- Botox 200 UNT Injection
- Keywords
- Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox 200 UNT InjectionDrug
Treatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A responder | Patients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1 Receives: 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 Receives: Drug: Botox 200 UNT Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients after onabotulinum a toxin injections who respond to treatment
Measured: 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
Measured: Received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 2013
- Primary completion1 Sep 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muharrem Baturu, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485453
- Sponsor's protocol ID
- GAUN-Urology-Baturu-001
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT06485453
- Acronym / sponsor ID
- GAUN-Urology-Baturu-001
- Conditions
- Neurogenic Bladder Disorder
- Keywords
- Onabotulinumtoxin A; Neurogenic lower urinary tract dysfunction; Urodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A responder | – | Drug: Botox 200 UNT InjectionPatients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1 |
| Botulinum Toxin A non-responder | – | Drug: Botox 200 UNT InjectionPatients who did not respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Neurogenic Lower Urinary Tract Disorder who didn't respond to anticholinergic treatment were the goal population.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox 200 UNT InjectionTreatment effect and duration of Onabotulinum Toxin A according to patient's pad usaged | Drug | Botulinum Toxin A non-responder, Botulinum Toxin A responder |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder Disorder, run by University of Gaziantep.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.