Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250543
• Other study ID #: IRP-2018-01-14
• Status: Completed
• Phase: Phase 4
• Start date: August 14, 2018
• Est. completion date: November 25, 2022

Study information

• Verified date: February 2024
• Source: University Medical Centre Maribor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Also the effect of local anesthesia on pain level of the procedure was assessed.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• AbobotulinumtoxinA 300 UNT
20 evenly distributed intradetrusor injections, 1 ml per site, were performed
• IncobotulinumtoxinA 100 UNT
20 evenly distributed intradetrusor injections, 1 ml per site, were performed
• Lidocain
30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter

Other:
• placebo
30 minutes before the procedure the bladder was instilled with 40 ml of 0.9% NaCl solution

Locations

Country	Name	City	State
Slovenia	University Medical Centre Maribor	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
Niko Kavcic

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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. — View Citation

Lange 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months
Secondary	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.	The day of procedure
Secondary	Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA	Frequency of adverse events (urinary retention, urinary tract infection)	5 months