- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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. april 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
829
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Gent, Belgia
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British Columbia
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Victoria, British Columbia, Canada
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Moscow, Den russiske føderasjonen
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California
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Newport Beach, California, Forente stater
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Warsaw, Polen
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London, Storbritannia
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Prague, Tsjekkia
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Tubingen, Tyskland
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 2
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 4
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Week 12 Treatment Cycle 2
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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 2
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Percentage of Patients With a Positive Response on the 4-Point TBS
Tidsramme: Week 12 Treatment Cycle 3
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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 3
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Percentage of Patients With a Positive Response on the 4-Point TBS
Tidsramme: 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.
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Week 12 Treatment Cycle 4
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Percentage of Patients With a Positive Response on the 4-Point TBS
Tidsramme: 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.
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Week 12 Treatment Cycle 5
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Percentage of Patients With a Positive Response on the 4-Point TBS
Tidsramme: 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.
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Week 12 Treatment Cycle 6
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Tidsramme: Study Baseline, Week 12 Treatment Cycle 1
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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).
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Tidsramme: Study Baseline, Week 12 Treatment Cycle 2
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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).
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Study Baseline, Week 12 Treatment Cycle 2
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 3
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Tidsramme: 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).
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Study Baseline, Week 12 Treatment Cycle 4
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Tidsramme: 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
Tidsramme: 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).
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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
Tidsramme: 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.
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Tidsramme: 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
Tidsramme: 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
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
Tidsramme: 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.
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the KHQ Role Limitations Domain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2010
Primær fullføring (Faktiske)
5. august 2014
Studiet fullført (Faktiske)
5. august 2014
Datoer for studieregistrering
Først innsendt
28. mai 2009
Først innsendt som oppfylte QC-kriteriene
4. juni 2009
Først lagt ut (Anslag)
8. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Atferdssymptomer
- Psykiske lidelser
- Urologiske sykdommer
- Urinblæresykdommer
- Nedre urinveissymptomer
- Urologiske manifestasjoner
- Vannlatingsforstyrrelser
- Eliminasjonsforstyrrelser
- Urinblæren, overaktiv
- Urininkontinens
- Enuresis
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylkolinfrigjøringshemmere
- Nevromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoksinA
Andre studie-ID-numre
- 191622-096
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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