Phase 3
Completed N=829
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
Source: ClinicalTrials.gov NCT00915525 ↗Enrolled (actual)
829
Serious AEs
7.6%
Results posted
Dec 2015
Primary outcomePrimary: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes — 5.55; -3.26 Incontinence Episodes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
5.65; 7.17; -3.05; -3.12 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS) |
74.0 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point TBS |
80.9; 81.3 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point TBS |
80.9; 81.3 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point TBS |
80.9; 81.3 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point TBS |
80.9; 81.3 | — |
| PRIMARY Percentage of Patients With a Positive Response on the 4-Point TBS |
80.9; 81.3 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Daily Average Number of Micturition Episodes |
11.85; 11.81; -2.76; -2.66 | — |
| SECONDARY Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score |
34.3; 26.0 | — |
| SECONDARY Change From Study Baseline in the I-QOL Questionnaire Total Summary Score |
30.3; 30.2; 22.6; 18.3 | — |
| SECONDARY Change From Study Baseline in the I-QOL Questionnaire Total Summary Score |
30.3; 30.2; 22.6; 18.3 | — |
| SECONDARY Change From Study Baseline in the I-QOL Questionnaire Total Summary Score |
30.3; 30.2; 22.6; 18.3 | — |
| SECONDARY Change From Study Baseline in the I-QOL Questionnaire Total Summary Score |
30.3; 30.2; 22.6; 18.3 | — |
| SECONDARY Change From Study Baseline in the I-QOL Questionnaire Total Summary Score |
30.3; 30.2; 22.6; 18.3 | — |
| SECONDARY Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain |
64.3; -28.5 | — |
| SECONDARY Change From Study Baseline in the KHQ Role Limitations Domain |
66.4; 60.3; -24.8; -22.9 | — |
| SECONDARY Change From Study Baseline in the KHQ Role Limitations Domain |
66.4; 60.3; -24.8; -22.9 | — |
| SECONDARY Change From Study Baseline in the KHQ Role Limitations Domain |
66.4; 60.3; -24.8; -22.9 | — |
| SECONDARY Change From Study Baseline in the KHQ Role Limitations Domain |
66.4; 60.3; -24.8; -22.9 | — |
| SECONDARY Change From Study Baseline in the KHQ Role Limitations Domain |
66.4; 60.3; -24.8; -22.9 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in the KHQ Social Limitations Domain |
46.7; 43.3; -17.0; -17.6 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
| SECONDARY Change From Study Baseline in Daily Frequency of Urgency Episodes |
8.98; 8.84; -3.95; -2.64 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00915525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.