A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Idiopathic Overactive Bladder with Urinary Incontinence

Allergan Ltd0 sites829 target enrollmentStarted: July 23, 2009Last updated: December 10, 2019

Drugs

Trial Snapshot

No summary available.

•1. Patient has participated in study 191622-095 or 191622-520 and fulfilled that study’s exit criteria (ie. completion of 24 weeks post Randomization / Day 1, and if a second treatment was received, completed at least 12 weeks post-treatment follow up).
•2. Written informed consent has been obtained.
•3. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
•4. Written Data Protection Consent (EU sites only) has been obtained.
•5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
•6. Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder following study treatment or at any other time if it is determined to be necessary by the investigator.
•7. Patient has a negative pregnancy test result if female and of childbearing potential.
•8. Patient is able to complete study requirements including using the toilet without assistance, is able to collect urine volume voided per micturition measurements over a 24-hour period, complete diaries and questionnaires, and attend all study visits in the opinion of the investigator.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 750
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 375
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 375

•1. Patient cannot withhold any anti-platelet, anti-coagulant therapy or medications with anticoagulant effects within 3 days prior to any study treatment.
•2. Patient has a known allergy or sensitivity to any botulinum toxin preparation (including the study medication preparation), anesthetics or antibiotics to be used during the study.
•3. Patient has experienced any serious adverse event related to the study procedure or treatment in the preceding study (191622-095 or 191622-520).
•4. Patient has had occurrence of bladder stones in the preceding study (191622-095 or 191622-520)
•5. Patient has any medical condition that may put them at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
•6. Females who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study (see section 8.2.3).
•7. Patient has any condition or situation which, in the investigator’s opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient’s participation in the study.

Sponsor

Allergan Ltd