Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2022-11-25

Brief Summary

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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.

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Detailed Description

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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

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AbobotulinumtoxinA and lidocaine

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.

Group Type OTHER

AbobotulinumtoxinA 300 UNT

Intervention Type DRUG

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

Lidocain

Intervention Type 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 placebo

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.

Group Type OTHER

AbobotulinumtoxinA 300 UNT

Intervention Type DRUG

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

placebo

Intervention Type OTHER

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

IncobotulinumtoxinA and lidocaine

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.

Group Type OTHER

IncobotulinumtoxinA 100 UNT

Intervention Type DRUG

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

Lidocain

Intervention Type DRUG

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

IncobotulinumtoxinA and placebo

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.

Group Type OTHER

IncobotulinumtoxinA 100 UNT

Intervention Type DRUG

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

placebo

Intervention Type OTHER

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

Interventions

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AbobotulinumtoxinA 300 UNT

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

Intervention Type DRUG

IncobotulinumtoxinA 100 UNT

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

Intervention Type DRUG

Lidocain

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

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No