Overactive BladderPhase 3NCT00915525
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
A Phase 3 study testing botulinum toxin Type A in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 8 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence
- What is being tested?
- botulinum toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 829 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Feb 2010to 5 Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
Who cannot join
- 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
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
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
- Being tested
- botulinum toxin Type A
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called BOTOX®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12 Treatment Cycle 6
Secondary outcomes (30)
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are 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 micturition 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 micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
Measured: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Measured: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Measured: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Measured: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Measured: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Measured: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Measured: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are 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 urgency 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 urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Measured: Study Baseline, Week 12 Treatment Cycle 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study start1 Feb 2010
- Primary completion5 Aug 2014
- Study completion5 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915525
- Sponsor's protocol ID
- 191622-096
- Status last verified
- Apr 2019
- First submitted
- 28 May 2009
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27038769
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00915525
- Acronym / sponsor ID
- 191622-096
- Conditions
- Overactive Bladder, Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 5 Aug 2014 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 18 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin Type A 100U | Experimental | Biological: botulinum toxin Type ABotulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. |
| botulinum toxin Type A 150U | Experimental | Biological: botulinum toxin Type ABotulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Type AAlso: BOTOX®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. | Biological | botulinum toxin Type A 100U, botulinum toxin Type A 150U |
Primary outcome
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 1
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).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 2
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).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 3
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).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 4
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).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 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 191622-096 (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).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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).
Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
Time frame: Week 12 Treatment Cycle 1
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.
Percentage of Patients With a Positive Response on the 4-Point TBS
Time frame: Week 12 Treatment Cycle 2
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.
Percentage of Patients With a Positive Response on the 4-Point TBS
Time frame: Week 12 Treatment Cycle 3
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.
Percentage of Patients With a Positive Response on the 4-Point TBS
Time frame: Week 12 Treatment Cycle 4
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.
Percentage of Patients With a Positive Response on the 4-Point TBS
Time frame: Week 12 Treatment Cycle 5
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.
Percentage of Patients With a Positive Response on the 4-Point TBS
Time frame: Week 12 Treatment Cycle 6
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.
30 secondary outcomes
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Time frame: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Role Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Social Limitations Domain
Time frame: Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in Daily Frequency of Urgency Episodes
Time frame: Study Baseline, Week 12 Treatment Cycle 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27038769Nitti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing botulinum toxin Type A in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Canada, Czechia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes (time frame: Study Baseline, Week 12 Treatment Cycle 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.