Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder

NCT06250543 | Completed Phase 4

• 1 other identifier: IRP-2018-01-14
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

botulinum toxin; overactive bladder; abobotulinumtoxinA; incobotulinumtoxinA; local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Value of Local Anesthesia for Pain Reduction

  The day of procedure

• Safety of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA

  5 months

Study Arms (4)

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.

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.

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.

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.

Drug: IncobotulinumtoxinA 100 UNT; Other: placebo

Interventions

AbobotulinumtoxinA 300 UNT DRUG

20 evenly distributed intradetrusor injections, 1 ml per site, were performed

AbobotulinumtoxinA and lidocaine; AbobotulinumtoxinA and placebo

IncobotulinumtoxinA 100 UNT DRUG

20 evenly distributed intradetrusor injections, 1 ml per site, were performed

IncobotulinumtoxinA and lidocaine; IncobotulinumtoxinA and placebo

Lidocain DRUG

30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter

AbobotulinumtoxinA and lidocaine; IncobotulinumtoxinA and lidocaine

placebo OTHER

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

AbobotulinumtoxinA and placebo; IncobotulinumtoxinA and placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niko Kavcic: lead

Study Sites (1)

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

Related 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.

  PMID: 33769020 BACKGROUND

• 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.

  PMID: 36835999 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Niko Kavčič, MD

  University Medical Centre Maribor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 9, 2024
• Study Start: August 14, 2018
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We intend to publish a research article in 2024. All supporting information will be shared with the journal.
• Access Criteria: Access will be provided by the journal.

Locations

SL (1)