Efficacy and tolerability of incobotulinumtoxin A in comparison with onabotulinumtoxinA in patients with overactive bladder syndrome.

Incobotulinumtoxin versus Onabotulinumtoxin in the treatment of patients with overactive bladder syndrome - Inco_Ona1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003949-28-IT

Enrollment

140

Registered

2021-06-08

Start date

2018-08-07

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurogenic overactive bladder MedDRA version: 20.0 Level: LLT Classification code 10032081 Term: Other functional disorder of bladder System Organ Class: 100000004857

Interventions

Trade Name: XEOMIN - 100 UNITA' DL50 POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO DI VETRO Product Name: xeomin Pharmaceutical Form: Powder for solution for injection CAS Number: 93384-43-1 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - patients (males and females) with neurogenic urge urinary incontinence (UUI) (with urgency, increase in day- time and night- time urinary frequency) and with urodynamic diagnosis of DO; - 18- 80 years; - women of childbearing age, who use a reliable method of contraception throughout the study period (a pregnancy test must be performed during enrolment in the study); - spinal cord injury at or below T1, diagnosed at least 6 months before the screening in case of a vesico-sphincter dysfunction due to spinal cord injury; - EDSS score = 6, in MS patients; - patients refractory to anticholinergic therapy (= 1 anticholinergic agent) - application of intermittent catheterizations to empty the bladder. In the case of spontaneous micturition, the patients should agree for the use of intermittent catheterizations, in case this will be necessary after treatment with the detrusor injection of botulinumtoxin A. Urodynamic characteristics: urodynamic diagnosis of DO, refractory to standard anticholinergics and naïve to intradetrusor injection of onabotulinumtoxin A. The wash- out period after anticholinergics has to be of at least 3 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria: - recurring urinary tract infections (UTIs) (= 4 episodes/year); - spinal cord injuries above T1; - MS patients: EDSS score = 6; - patients who won’t or can’t perform intermittent catheterization; - pregnancy or breast- feeding, if female patients - post- void residual volume (PRV) > 150 ml, in the case of spontaneous micturition

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare Incobot/A versus Onabot/A in order to evaluate if the differencies in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic OAB. The study is aimed to assess the equivalence or the superiority of Incobotulinumtoxin A versus Onabotulinumtoxin A on the efficacy and safety parameters. ;Secondary Objective: na ;Primary end point(s): -Significant reduction in the frequency of urinary incontinence episodes as compared to baseline (according to the 3-day voiding diary) at 2, 4 and 24 weeks after treatment; -reduction in the frequency of urinary tract infections at 2, 12 and 24 weeks after treatment, with a major (significant reduction) in patients in Group 1 (Incobot/A) as compared to baseline. ;Timepoint(s) of evaluation of this end point: 2, 12 and 24 weeks	—

Measure

Time frame

Main Objective: The aim of the study is to compare Incobot/A versus Onabot/A in order to evaluate if the differencies in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic OAB. The study is aimed to assess the equivalence or the superiority of Incobotulinumtoxin A versus Onabotulinumtoxin A on the efficacy and safety parameters. ;Secondary Objective: na ;Primary end point(s): -Significant reduction in the frequency of urinary incontinence episodes as compared to baseline (according to the 3-day voiding diary) at 2, 4 and 24 weeks after treatment; -reduction in the frequency of urinary tract infections at 2, 12 and 24 weeks after treatment, with a major (significant reduction) in patients in Group 1 (Incobot/A) as compared to baseline. ;Timepoint(s) of evaluation of this end point: 2, 12 and 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline; - Significant improvement in I-QoL score at 2, 12 and 24 weeks as compared to baseline; - Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml, at 2, 12 and 24 weeks after treatment. ;Timepoint(s) of evaluation of this end point: - Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline; - Significant improvement in I-QoL score at 2, 12 and 24 weeks as compared to baseline; - Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml, at 2, 12 and 24 weeks after treatment.	—

Measure

Time frame

Secondary end point(s): - Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline; - Significant improvement in I-QoL score at 2, 12 and 24 weeks as compared to baseline; - Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml, at 2, 12 and 24 weeks after treatment. ;Timepoint(s) of evaluation of this end point: - Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline; - Significant improvement in I-QoL score at 2, 12 and 24 weeks as compared to baseline; - Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml, at 2, 12 and 24 weeks after treatment.

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Countries

Italy

Contacts

Public ContactClinica Urologica ad indirizzo Onco

Universit¿ degli Studi di Perugia

roberta.cagini@unipg.it0755783898

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026