Idiopathic Overactive Bladder Resistant to Anticholinergic TreatmentNCT06408051
Efficacy of 200 IU OnabotulinumtoxinA in Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
An observational study of Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
- What is being tested?
- Injection of onabotulinumtoxinA into the bladder wall
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 31 Jul 2023
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In patients with overactive bladder and urinary incontinence who had previously failed to respond to anticholinergic treatments
Who may be able to join
- overactive bladder urge incontinence
Who cannot join
- neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basri Cakiroglu
Istanbul, 34768
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients With Idiopathic
This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.
Read the detailed description
The efficacy of OnabotulinumtoxinA was investigated in patients who attended urology outpatient clinics between January 2016 and June 2022 for overactive bladder unresponsive to anticholinergic therapy. Baseline symptoms and quality of life data were compared to those at month 6 after the treatment. The voiding diary (for 3 days) of each patient was reviewed to assess and record patients' symptoms. Baseline ultrasound (US)-measured post-void residual urine (PVR) and bladder wall thickness (BWT) values were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, patients diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded from the study.
- Being tested
- Injection of onabotulinumtoxinA into the bladder wall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of onabotulinumtoxinA into the bladder wallProcedure or surgery
BTX was injected into the detrusor muscles at 20 sites
| Study group | Role | What they receive |
|---|---|---|
| singel | Not described Receives: Procedure: Injection of onabotulinumtoxinA into the bladder wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequencies of urination, nocturia, incontinence episodes
below 8,above 8
Measured: 1 years
urgency,
present or absent
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jan 2020
- Primary completion31 Jan 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Overactive Bladder Resistant to Anticholinergic TreatmentStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408051
- Sponsor's protocol ID
- 10.11.203/23-54
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients With Idiopathic
- ClinicalTrials.gov ID
- NCT06408051
- Acronym / sponsor ID
- 10.11.203/23-54
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 May 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.
This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.
Detailed description
The efficacy of OnabotulinumtoxinA was investigated in patients who attended urology outpatient clinics between January 2016 and June 2022 for overactive bladder unresponsive to anticholinergic therapy. Baseline symptoms and quality of life data were compared to those at month 6 after the treatment. The voiding diary (for 3 days) of each patient was reviewed to assess and record patients' symptoms. Baseline ultrasound (US)-measured post-void residual urine (PVR) and bladder wall thickness (BWT) values were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, patients diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded from the study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| singel | – | Procedure: Injection of onabotulinumtoxinA into the bladder wall |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In patients with overactive bladder and urinary incontinence who had previously failed to respond to anticholinergic treatments
Key inclusion criteria (1 listed)
- overactive bladder urge incontinence
Key exclusion criteria (1 listed)
- neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction
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 |
|---|---|---|
| Injection of onabotulinumtoxinA into the bladder wallBTX was injected into the detrusor muscles at 20 sites | Procedure or surgery | singel |
Primary outcome
frequencies of urination, nocturia, incontinence episodes
Time frame: 1 years
below 8,above 8
urgency,
Time frame: 1 years
present or absent
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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
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 1 inclusion and 1 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
frequencies of urination, nocturia, incontinence episodes (time frame: 1 years). The study lists 2 primary outcomes in all. 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 27 Dec 2024.