Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

NCT00915525 | Completed Phase 3 Results

• 1 other identifier: 191622-096
• Study Type: interventional
• Target: 829
• Locations: 8 countries
• Sites: 8

Brief Summary

The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.

Conditions

Overactive Bladder; Urinary Incontinence

Outcome Measures

Primary Outcomes (12)

• 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 Treatment Cycle 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  Study Baseline, Week 12 Treatment Cycle 6

• Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 1

• Percentage of Patients With a Positive Response on the 4-Point TBS

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 2

• Percentage of Patients With a Positive Response on the 4-Point TBS

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 3

• Percentage of Patients With a Positive Response on the 4-Point TBS

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 4

• Percentage of Patients With a Positive Response on the 4-Point TBS

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 5

• Percentage of Patients With a Positive Response on the 4-Point TBS

  The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  Week 12 Treatment Cycle 6

Secondary Outcomes (30)

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

  Study Baseline, Week 12 Treatment Cycle 1

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

  Study Baseline, Week 12 Treatment Cycle 2

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

  Study Baseline, Week 12 Treatment Cycle 3

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

  Study Baseline, Week 12 Treatment Cycle 4

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

  Study Baseline, Week 12 Treatment Cycle 5

Study Arms (2)

botulinum toxin Type A 100U

EXPERIMENTAL

Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Biological: botulinum toxin Type A

botulinum toxin Type A 150U

EXPERIMENTAL

Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type A BIOLOGICAL

Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Also known as: BOTOX®

botulinum toxin Type A 100U; botulinum toxin Type A 150U

Eligibility Criteria

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

You may qualify if:

• Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)

You may not qualify if:

• Females who are pregnant, nursing or planning a pregnancy
• Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.

  PMID: 27038769 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

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; Urination Disorders

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 8, 2009
• Study Start: February 1, 2010
• Primary Completion: August 5, 2014
• Study Completion: August 5, 2014
• Last Updated: April 30, 2019
• Results First Posted: December 18, 2015

Record last verified: 2019-04

Locations

PL (1); CA (1); GB (1); US (1); DE (1); CZ (1); RU (1); BE (1)