Status:
UNKNOWN
Overactive Bladder Syndrome: Incobotulinumtoxin Versus Onabotulinumtoxin
Lead Sponsor:
University Of Perugia
Conditions:
Overactive Bladder Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate if the differences in the pharmacologic formulations between the two drugs could affect their efficacy and s...
Detailed Description
This is a pilot, prospective, randomized, double blinded, multicentre, clinical trial. After giving a written informed consent, all the patients will be randomized into two groups: Group 1, including ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- hypersensitivity to the active substance or to any of the excipients (listed in section 6.1 of RCP);
- generalized diseases of muscular activity (e.g. myasthenia gravis, Lambert-Eaton syndrome);
- presence of infection or inflammation at the injection site;
- patients with acute urinary retention at the time of treatment, not routinely subjected to catheterization;
- men with overactive bladder and signs or symptoms of urinary obstruction should not be treated;
- documented or suspected active malignant neoplasia or previous history, within 2 years prior to screening;
- patients who must or want to continue taking illegal drugs or drugs that may interfere with the proper conduct of the study;
- chronic abuse of alcohol or drugs or any condition that in the opinion of the investigator doctor makes an unreliable subject in correctly completing the study procedures;
- any other clinical condition that would endanger the safety of patients in participating in the study or that could prevent the subjects from adhering to the protocol.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03758235
Start Date
September 1 2018
End Date
September 1 2021
Last Update
November 6 2020
Active Locations (1)
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1
Antonella Giannantoni
Siena, SI, Italy, 53100