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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Biological: Botulinum Toxin Type A 200U; Biological: Botulinum Toxin Type A 300U

• Registration Number: NCT00876447
• Lead Sponsor: Allergan

Brief Summary

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).

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.

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2013-06-12
• Study Completion: 2013-09-04
• Results First Submitted: 2014-06-12
• Results First Submitted QC: 2014-06-12
• Results First Posted: 2014-06-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin Type A 200U	Botulinum Toxin Type A 200U	Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 300U	Botulinum Toxin Type A 300U	Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.

Primary Outcome Measures

Name	Time	Method
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes	Study Baseline, Week 6 Treatment Cycle 5	Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Secondary Outcome Measures

Name	Time	Method
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score	Study Baseline, Week 6 Treatment Cycle 5	The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Change From Study Baseline in Volume Per Void	Study Baseline, Week 6 Treatment Cycle 5	The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.