Clinical trial NCT06250543: Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: botulinum toxin
overactive bladder
abobotulinumtoxinA
incobotulinumtoxinA
local anesthesia
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
timeFrame: 5 months
Secondary outcomes:
measure: The Value of Local Anesthesia for Pain Reduction
timeFrame: The day of procedure
measure: Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA
timeFrame: 5 months
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
Study officials:
affiliation: University Medical Centre Maribor
name: Niko Kavčič, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.