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

Phase 1

• Conditions: neurogenic overactive bladder; MedDRA version: 20.0Level: LLTClassification code 10032081Term: Other functional disorder of bladderSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2016-003949-28-IT
• Lead Sponsor: PROF. ANTONELLA GIANNANTONI - CLINICA UROLOGICA - UNIVERSITà DI PERUGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified