A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - Long term Follow Up study of BOTOX in Neurogenic Detrusor Overactivity

Conditions: rinary incontinence caused by neurogenic detrusor overactivity
MedDRA version: 12.0Level: LLTClassification code 10029279Term: Neurogenic bladder

Registration Number: EUCTR2009-009216-53-IT

Lead Sponsor: Allergan Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. The patient has successfully completed participation to the study 191622-515 or 191622-516 and the following criteria are met : The patient has completed at least 52 week in the previous study, with at least 12 week of follow up after the most recent treatment No more than 6 months have elapsed since the completion of the previous study 2. Written informed consent form has been obtained 3. Written authorization for the use and release of health and research study data has been obtained (only for US sites) 4. Written authorization for the protection and use of personal data has been obtained (only for EU sites) 5. Written documentation has been obtained in keeping with national and local data protection requirements, where applicable. 6. In the investigator?s opinion the patient is able to fulfill the study requirements, including diary completion and is available to attend all the study visits. 7. Current use or availability to use clean intermittent catheterization (CIC) for the bladder emptying (indwelling catheter is not allowed).A caregiver may perform the CIC. 8. Negative pregnancy test for female of childbearing potential 9. Weight equal or more than 50 kg (110 lb)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Evidences of any pelvic or urological abnormalities, including, but not limited to : Interstitial cystitis in the investigator?s opinion Presence of bladder stones, including the ones detected during the preceding study Surgery or bladder disease other than detrusor overactivity , which can affect the bladder function (excepted than surgery performed more than one year before the screening for the preceding study for stress incontinence, uterine prolapse, rectocele or cystocele). 2. Preceding therapy with any serotype of botulinum toxin for any type of urological disease (except than treatment administered for the preceding study participation) 3. The patient was administered any serotype of botulinum toxin for any non urological disease within 12 weeks before the study entry/day 1. 4. The patient has been immunized for any serotype of botulinum toxin 5. Preceding or present diagnosis of prostate cancer 6. Preceding or present diagnosis of bladder cancer 7. Hemophilia or other clotting factors deficits or disorders that cause bleeding diathesis 8. Concurrent treatment or within 6 months from study entry/day 1 with intravescical capsaicin, resiniferatoxin, or any other intravesical treatment for overactive bladder 9. Present use or willing to use an implanted or non-implanted electrostimulation/neuromodulation device for treatment of overactive bladder or a baclofen pump. 10. Allergy or sensitivity to any components of the study medication, anesthetics or antibiotic or any other products associated to the treatment or to the general study procedures. 11. Medical conditions that that may expose the patient to a major risk as a result from the exposure to BOTOX, including myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis. 12. Pregnant women, nursing or who plans to become pregnant during the study or female of childbearing potential who are unable or not willing to use an adequate contraception method during the study. 13. Condition or situation which, in the investigator?s opinion, can expose the patient to considerable risks, confound the study results or meaningfully interfere with the patient?s participation to the study. 14. Patients who are participating or participated to another study on medicines or devices after exiting the191622-515 or 191622-516 study. 15. Any serious adverse event related to the study drug or to the study treatment during the 191622-515 or 191622-516 study.