A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00876447

Purpose

The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

Condition	Intervention	Phase
Overactive Bladder	Biological: Botulinum toxin Type A 200U Biological: Botulinum toxin Type A 300U	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Multiple Sclerosis Urinary Incontinence

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

The change from baseline in the daily average frequency of episodes of urinary incontinence (patient diary) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incontinence Quality of Life Instrument (I-QOL) total summary score [ Time Frame: Treatment day, Week 6, 12, and every 12 weeks thereafter, post treatment ] [ Designated as safety issue: No ]
Total volume voided recorded over one 24 hour period as recorded by patient bladder diary for all voids (catheterization and voluntary) [ Time Frame: Treatment day, Week 2, 6, 12, and every 12 weeks thereafter, post treatment ] [ Designated as safety issue: No ]
Number of episodes of voiding and method (catheterization and voluntary) as recorded by patient bladder diary [ Time Frame: Treatment day, Week 2, 6, 12, and every 12 weeks thereafter, post treatment ] [ Designated as safety issue: No ]
Average time between treatments [ Time Frame: Every 6-12 weeks ] [ Designated as safety issue: No ]
Incontinence Quality of Life Instrument Neurogenic Module [ Time Frame: Treatment day, Week 6, 12, and every 12 weeks thereafter, post treatment ] [ Designated as safety issue: No ]
Post Void Residual Volume [ Time Frame: Qualification day, week 2, 6, 12, and every 12 weeks thereafter, post treatment ] [ Designated as safety issue: No ]

Enrollment:	397
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BOTOX 200U	Biological: Botulinum toxin Type A 200U botulinum toxin Type A 200U injections into detrusor > 12 weeks for 3 years Other Name: BOTOX®
Experimental: 2 BOTOX 300U	Biological: Botulinum toxin Type A 300U botulinum toxin Type A 300U injections into detrusor > 12 weeks for 3 years Other Name: BOTOX®

Detailed Description:

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
- Patient completed at least 52 weeks in the preceding study.
- No longer than 6 months has elapsed since completion of the preceding study
- Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.

Exclusion Criteria:

History or evidence of pelvic or urologic abnormality.
Previous or current diagnosis of bladder or prostate cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876447

Show 22 Study Locations

Sponsors and Collaborators

Allergan

Investigators

Study Chair:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00876447 History of Changes
Other Study ID Numbers:	191622-094
Study First Received:	April 1, 2009
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Urinary Bladder, Overactive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012