Overactive BladderPhase 4NCT06250543
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder
A Phase 4 study testing AbobotulinumtoxinA 300 UNT, IncobotulinumtoxinA 100 UNT and Lidocain in people with Overactive Bladder, run by Niko Kavcic at 1 site in Slovenia.
Trial summary
A randomized, single blind, non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- AbobotulinumtoxinA 300 UNT, IncobotulinumtoxinA 100 UNT and Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSlovenia
- Study dates
- 14 Aug 2018to 25 Nov 2022
- Phase
- Phase 4
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female, age between 18 and 90, presence of urinary urgency with urgency urinary incontinence, residual urine below 150 ml, previous non-pharmacological conservative treatments (e.g., pelvic floor muscle training) inefficiency, anticholinergic or beta-3 agonist treatment inefficiency.
Who cannot join
- patients that already have received treatment with botulinum toxin, pregnancy or breast- feeding and any diseases or functional abnormalities that might affect bladder function. Patients with stress urinary incontinence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA Efficacy and Safety in Women With Overactive Bladder and Urge Urinary Incontinence and the Value of Local Anesthesia for Pain Reduction
A randomized, single blind, non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also the effect of local anesthesia on pain level of the procedure was assessed.
Read the detailed description
In the described prospective, clinical trial, approved by the National Medical Ethics Committee (protocol number: 0120-44/2018/5; date of approval: 22/02/2018), female patients were enrolled, followed by signed informed consent.
Before treatment patients underwent history and physical examination. Before botulinum toxin injection each patient completed three questionnaires, UDI-6 (Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire), I-QOL (Incontinence Quality of Life). The total score of each questionnaire was considered. Before botulinum toxin injection, urinalysis was performed to check for a urinary tract infection (UTI). For those presenting with UTI, treatment was postponed until the UTI was treated and a repeat urinalysis was performed. Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the procedure. Patients were randomised to receive either 300 units of AbobotulinumtoxinA (Dysport®) or 100 units of IncobotulinumtoxinA (Xeomin®). They were further randomised to receive local anesthesia or placebo. 30 minutes before the procedure the bladder was instilled with either 40 ml 1% lidocaine solution using a 16Fr urethral Foley catheter or with 40 ml 0.9% NaCl solution. All patients received urethral lubrication gel. Using rigid cystoscopy, normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. During the procedure the patients graded the pain level of every injection on a Visual Analog Scale (VAS). All patients were treated in an outpatient clinic and by one experienced surgeon.
After 1 to 2 weeks patients were seen for evaluation of systemic side effects, physical examination, measurement of residual urine and urinalysis to eventually diagnose and treat a urinary tract infection. After 4 months patients were seen to evaluate the treatment result and complete the questionnaires, IIQ-7, UDI-6, patient satisfaction survey and I-QOL. Side effects were monitored for 5 months after the procedure.
- Conditions
- Overactive Bladder
- Being tested
- AbobotulinumtoxinA 300 UNT, IncobotulinumtoxinA 100 UNT, Lidocain, placebo
- Keywords
- botulinum toxin, overactive bladder, abobotulinumtoxinA, incobotulinumtoxinA, local anesthesia
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinA 300 UNTDrug
20 evenly distributed intradetrusor injections, 1 ml per site, were performed
IncobotulinumtoxinA 100 UNTDrug
20 evenly distributed intradetrusor injections, 1 ml per site, were performed
LidocainDrug
30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter
placeboOther
30 minutes before the procedure the bladder was instilled with 40 ml of 0.9% NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| AbobotulinumtoxinA and lidocaine | Other | The bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter.
30 minutes afterwards patients received 300 units of AbobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. Receives: Drug: AbobotulinumtoxinA 300 UNT; Drug: Lidocain |
| AbobotulinumtoxinA and placebo | Other | The bladder was instilled with 40 ml of 0.9% NaCl solution using a 16Fr urethral Foley catheter.
30 minutes afterwards patients received 300 units of AbobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. Receives: Drug: AbobotulinumtoxinA 300 UNT; Other: placebo |
| IncobotulinumtoxinA and lidocaine | Other | The bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter.
30 minutes afterwards patients received 100 units of IncobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. Receives: Drug: IncobotulinumtoxinA 100 UNT; Drug: Lidocain |
| IncobotulinumtoxinA and placebo | Other | The bladder was instilled with 40 ml of 0.9% NaCl solution using a 16Fr urethral Foley catheter.
30 minutes afterwards patients received 100 units of IncobotulinumtoxinA. using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. Receives: Drug: IncobotulinumtoxinA 100 UNT; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
Questionnaire scores of UDI-6 (Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire) and I-QOL (Incontinence Quality of Life) will be evaluated before and after the procedure for non-inferiority of the two drugs.
Measured: 5 months
Secondary outcomes (2)
The Value of Local Anesthesia for Pain Reduction
During the procedure the patients graded the pain level of every injection on a Visual Analog Scale (VAS). The total score of each questionnaire will be evaluated for non-inferiority of placebo in comparison to local anesthesia.
Measured: The day of procedure
Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
Frequency of adverse events (urinary retention, urinary tract infection)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start14 Aug 2018
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to receive 20 intradetrusor injections of either 300 U AbobotulinumtoxinA or 100 U IncobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml of 1% lidocaine solution) or placebo before botulinum toxin injection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niko Kavcic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niko Kavcic, University Medical Centre Maribor
- Investigators
- Niko Kavčič, MD, Principal investigator, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250543
- Sponsor's protocol ID
- IRP-2018-01-14
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to publish a research article in 2024. All supporting information will be shared with the journal.
Publications
Giannantoni A, Gubbiotti M, Rubilotta E, Balzarro M, Antonelli A, Bini V. IncobotulinumtoxinA versus onabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial. Minerva Urol Nephrol. 2022 Oct;74(5):625-635. doi: 10.23736/S2724-6051.21.04227-2. Epub 2021 Mar 26.
PubMed 33769020Lange S, Koch M, Lange R, Husslein H, Umek W, Bodner-Adler B. Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland. J Clin Med. 2023 Feb 12;12(4):1462. doi: 10.3390/jcm12041462.
PubMed 36835999
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA Efficacy and Safety in Women With Overactive Bladder and Urge Urinary Incontinence and the Value of Local Anesthesia for Pain Reduction
- ClinicalTrials.gov ID
- NCT06250543
- Acronym / sponsor ID
- IRP-2018-01-14
- Conditions
- Overactive Bladder
- Keywords
- botulinum toxin, overactive bladder, abobotulinumtoxinA, incobotulinumtoxinA, local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Niko KavcicUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 9 Feb 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.
A randomized, single blind, non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also the effect of local anesthesia on pain level of the procedure was assessed.
Detailed description
In the described prospective, clinical trial, approved by the National Medical Ethics Committee (protocol number: 0120-44/2018/5; date of approval: 22/02/2018), female patients were enrolled, followed by signed informed consent.
Before treatment patients underwent history and physical examination. Before botulinum toxin injection each patient completed three questionnaires, UDI-6 (Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire), I-QOL (Incontinence Quality of Life). The total score of each questionnaire was considered. Before botulinum toxin injection, urinalysis was performed to check for a urinary tract infection (UTI). For those presenting with UTI, treatment was postponed until the UTI was treated and a repeat urinalysis was performed. Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the procedure. Patients were randomised to receive either 300 units of AbobotulinumtoxinA (Dysport®) or 100 units of IncobotulinumtoxinA (Xeomin®). They were further randomised to receive local anesthesia or placebo. 30 minutes before the procedure the bladder was instilled with either 40 ml 1% lidocaine solution using a 16Fr urethral Foley catheter or with 40 ml 0.9% NaCl solution. All patients received urethral lubrication gel. Using rigid cystoscopy, normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. During the procedure the patients graded the pain level of every injection on a Visual Analog Scale (VAS). All patients were treated in an outpatient clinic and by one experienced surgeon.
After 1 to 2 weeks patients were seen for evaluation of systemic side effects, physical examination, measurement of residual urine and urinalysis to eventually diagnose and treat a urinary tract infection. After 4 months patients were seen to evaluate the treatment result and complete the questionnaires, IIQ-7, UDI-6, patient satisfaction survey and I-QOL. Side effects were monitored for 5 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients were randomized to receive 20 intradetrusor injections of either 300 U AbobotulinumtoxinA or 100 U IncobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml of 1% lidocaine solution) or placebo before botulinum toxin injection.
| Arm | Type | Receives |
|---|---|---|
| AbobotulinumtoxinA and lidocaine | Other | Drug: AbobotulinumtoxinA 300 UNT, Drug: LidocainThe bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter. 30 minutes afterwards patients received 300 units of AbobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. |
| AbobotulinumtoxinA and placebo | Other | Drug: AbobotulinumtoxinA 300 UNT, Other: placeboThe bladder was instilled with 40 ml of 0.9% NaCl solution using a 16Fr urethral Foley catheter. 30 minutes afterwards patients received 300 units of AbobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. |
| IncobotulinumtoxinA and lidocaine | Other | Drug: IncobotulinumtoxinA 100 UNT, Drug: LidocainThe bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter. 30 minutes afterwards patients received 100 units of IncobotulinumtoxinA using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. |
| IncobotulinumtoxinA and placebo | Other | Drug: IncobotulinumtoxinA 100 UNT, Other: placeboThe bladder was instilled with 40 ml of 0.9% NaCl solution using a 16Fr urethral Foley catheter. 30 minutes afterwards patients received 100 units of IncobotulinumtoxinA. using rigid cystoscopy. Normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female, age between 18 and 90, presence of urinary urgency with urgency urinary incontinence, residual urine below 150 ml, previous non-pharmacological conservative treatments (e.g., pelvic floor muscle training) inefficiency, anticholinergic or beta-3 agonist treatment inefficiency.
Key exclusion criteria (1 listed)
- patients that already have received treatment with botulinum toxin, pregnancy or breast- feeding and any diseases or functional abnormalities that might affect bladder function. Patients with stress urinary incontinence.
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 |
|---|---|---|
| AbobotulinumtoxinA 300 UNT20 evenly distributed intradetrusor injections, 1 ml per site, were performed | Drug | AbobotulinumtoxinA and lidocaine, AbobotulinumtoxinA and placebo |
| IncobotulinumtoxinA 100 UNT20 evenly distributed intradetrusor injections, 1 ml per site, were performed | Drug | IncobotulinumtoxinA and lidocaine, IncobotulinumtoxinA and placebo |
| Lidocain30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter | Drug | AbobotulinumtoxinA and lidocaine, IncobotulinumtoxinA and lidocaine |
| placebo30 minutes before the procedure the bladder was instilled with 40 ml of 0.9% NaCl solution | Other | AbobotulinumtoxinA and placebo, IncobotulinumtoxinA and placebo |
Primary outcome
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
Time frame: 5 months
Questionnaire scores of UDI-6 (Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire) and I-QOL (Incontinence Quality of Life) will be evaluated before and after the procedure for non-inferiority of the two drugs.
2 secondary outcomes
The Value of Local Anesthesia for Pain Reduction
Time frame: The day of procedure
Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
Time frame: 5 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 12 Feb 2024.
- Background: PubMed 33769020Giannantoni A, Gubbiotti M, Rubilotta E, Balzarro M, Antonelli A, Bini V. IncobotulinumtoxinA versus onabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial. Minerva Urol Nephrol. 2022 Oct;74(5):625-635. doi: 10.23736/S2724-6051.21.04227-2. Epub 2021 Mar 26.
- Background: PubMed 36835999Lange S, Koch M, Lange R, Husslein H, Umek W, Bodner-Adler B. Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland. J Clin Med. 2023 Feb 12;12(4):1462. doi: 10.3390/jcm12041462.
- Individual participant dataSharing planned: Yes. We intend to publish a research article in 2024. All supporting information will be shared with the journal.
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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.
Niko Kavčič, MD principal investigator
University Medical Centre Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AbobotulinumtoxinA 300 UNT, IncobotulinumtoxinA 100 UNT and Lidocain in people with Overactive Bladder, run by Niko Kavcic at 1 site in Slovenia.
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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250543, which also lists 2 linked publications.
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 12 Feb 2024.