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

NCT00876447 | Completed Phase 3 Results

• 1 other identifier: 191622-094
• Study Type: interventional
• Target: 397
• Locations: 21 countries
• Sites: 21

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).

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (5)

• Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

  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).

  Study Baseline, Week 6 Treatment Cycle 1

• Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

  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).

  Study Baseline, Week 6 Treatment Cycle 2

• Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

  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).

  Study Baseline, Week 6 Treatment Cycle 3

• Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

  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).

  Study Baseline, Week 6 Treatment Cycle 4

• Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

  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).

  Study Baseline, Week 6 Treatment Cycle 5

Secondary Outcomes (10)

• Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

  Study Baseline, Week 6 Treatment Cycle 1

• Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

  Study Baseline, Week 6 Treatment Cycle 2

• Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

  Study Baseline, Week 6 Treatment Cycle 3

• Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

  Study Baseline, Week 6 Treatment Cycle 4

• Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

  Study Baseline, Week 6 Treatment Cycle 5

Study Arms (2)

Botulinum Toxin Type A 300U

EXPERIMENTAL

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

Biological: Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

EXPERIMENTAL

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

Biological: Botulinum Toxin Type A 200U

Interventions

Botulinum Toxin Type A 300U BIOLOGICAL

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

Also known as: BOTOX®

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U BIOLOGICAL

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

Also known as: BOTOX®

Botulinum Toxin Type A 200U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (22)

Unknown Facility

Middlebury, Connecticut, United States

Location

Unknown Facility

Randwick, Australia

Location

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Ostrava, Czechia

Location

Unknown Facility

Salouël, France

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Florence, Italy

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Epsom, New Zealand

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Porto, Portugal

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Prešov, Slovakia

Location

Unknown Facility

Pretoria, South Africa

Location

Unknown Facility

Santa Cruz de Tenerife, Spain

Location

Unknown Facility

Hualien City, Taiwan

Location

Unknown Facility

Kiev, Ukraine

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.

  PMID: 26607743 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 6, 2009
• Study Start: January 1, 2009
• Primary Completion: June 12, 2013
• Study Completion: September 4, 2013
• Last Updated: May 1, 2019
• Results First Posted: June 13, 2014

Record last verified: 2019-04

Locations

CZ (1); DE (1); BR (1); PL (1); SG (1); AU (1); ZA (1); US (1); UA (1); BE (1); TW (1); IT (1); CA (1); FR (1); PT (1); SL (1); NL (1); ES (1); RU (1); NZ (1); GB (1)