- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00915525
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
18 aprile 2019 aggiornato da: Allergan
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
829
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Gent, Belgio
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British Columbia
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Victoria, British Columbia, Canada
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Prague, Cechia
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Moscow, Federazione Russa
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Tubingen, Germania
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Warsaw, Polonia
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London, Regno Unito
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California
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Newport Beach, California, Stati Uniti
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: botulinum toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
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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.
Altri nomi:
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Sperimentale: botulinum toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
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Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Lasso di tempo: 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).
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Study Baseline, Week 12 Treatment Cycle 6
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Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
Lasso di tempo: Week 12 Treatment Cycle 1
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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.
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Week 12 Treatment Cycle 1
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Percentage of Patients With a Positive Response on the 4-Point TBS
Lasso di tempo: 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.
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Week 12 Treatment Cycle 2
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Percentage of Patients With a Positive Response on the 4-Point TBS
Lasso di tempo: 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.
|
Week 12 Treatment Cycle 3
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Percentage of Patients With a Positive Response on the 4-Point TBS
Lasso di tempo: 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.
|
Week 12 Treatment Cycle 4
|
Percentage of Patients With a Positive Response on the 4-Point TBS
Lasso di tempo: 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.
|
Week 12 Treatment Cycle 5
|
Percentage of Patients With a Positive Response on the 4-Point TBS
Lasso di tempo: 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.
|
Week 12 Treatment Cycle 6
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 1
|
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).
|
Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 2
|
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).
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 3
|
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).
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 4
|
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).
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 5
|
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).
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the Daily Average Number of Micturition Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 6
|
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).
|
Study Baseline, Week 12 Treatment Cycle 6
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Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 1
|
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.
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 2
|
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
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 3
|
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
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 4
|
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
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 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 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 6
|
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
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 1
|
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.
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in the KHQ Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 2
|
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.
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the KHQ Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 3
|
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.
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the KHQ Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 4
|
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.
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the KHQ Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 5
|
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.
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the KHQ Role Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 6
|
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.
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 1
|
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.
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 2
|
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.
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 3
|
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.
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 4
|
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.
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 5
|
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.
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the KHQ Social Limitations Domain
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 6
|
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.
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 1
|
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).
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 2
|
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).
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 3
|
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).
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 4
|
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).
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 5
|
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).
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Lasso di tempo: Study Baseline, Week 12 Treatment Cycle 6
|
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).
|
Study Baseline, Week 12 Treatment Cycle 6
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2010
Completamento primario (Effettivo)
5 agosto 2014
Completamento dello studio (Effettivo)
5 agosto 2014
Date di iscrizione allo studio
Primo inviato
28 maggio 2009
Primo inviato che soddisfa i criteri di controllo qualità
4 giugno 2009
Primo Inserito (Stima)
8 giugno 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 aprile 2019
Ultimo verificato
1 aprile 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Sintomi comportamentali
- Disordini mentali
- Malattie urologiche
- Malattie della vescica urinaria
- Sintomi del tratto urinario inferiore
- Manifestazioni urologiche
- Disturbi della minzione
- Disturbi di eliminazione
- Vescica urinaria, iperattiva
- Incontinenza urinaria
- Enuresi
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Agenti colinergici
- Modulatori di trasporto a membrana
- Inibitori del rilascio di acetilcolina
- Agenti neuromuscolari
- Tossine botuliniche
- Tossine botuliniche, tipo A
- abobotulinumtoxin A
Altri numeri di identificazione dello studio
- 191622-096
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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