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Study Title and Description

Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder.
Author Rovner E., Kennelly M., Schulte-Baukloh H., Zhou J., Haag-Molkenteller C., Dasgupta P.
Country Department of Urology, Medical University of South Carolina, Charleston, South Carolina 29403, USA. rovnere@musc.edu
Year 2011
Numbers Pubmed ID: 21351127

Secondary Publication Information
UI Title Author Country Year
Treatment satisfaction and goal attainment with onabotulinumtoxinA in patients with incontinence due to idiopathic OAB. Brubaker L., Gousse A., Sand P., Thompson C., Patel V., Zhou J., Jenkins B., Sievert KD. Department of Obstetrics and Gynecology, Stritch School of Medicine, Loyola University Chicago, 2160 S. First Avenue, Chicago, IL 60153, USA. Lbrubaker@lumc.edu 2012
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Extraction Form: All studies
Arms
Number Title Description Comments
1 OnabotulinumtoxinA 50 units 50 units once
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2 Placebo once
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3 OnabotulinumtoxinA 100 units 100 units once
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4 OnabotulinumtoxinA 150 units 150 units once
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5 OnabotulinumtoxinA 200 units 200 units once
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6 OnabotulinumtoxinA 300 units 300 units once
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries US, Canada, UK
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Funding source Industry funded/industry provided materials
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Inclusion criteria Symptoms of idiopathic OAB with UUI for at least 6 months At least 8 UUI episodes/week (with no more than 1 incontinence-free day/week); Urinary frequency (defined as an average of at least 8 micturitions/day) Failed at least 1 anti-cholinergic drug
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Exclusion criteria Stress-predominant urinary incontinence Use of clean intermittent catheterization(CIC) History or evidence of pelvic or urologic abnormalities or diseases affecting bladder function Patients who had been treated for at least 2 urinary tract infections within 6 months 24-hr total urine volume voided>3,000 ml or post-void residual (PVR) urine volume>200 ml at screening
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UI type 100
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0
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Age 58.8
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mean
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13.5
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18
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85
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Men included 8
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Special populations
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118
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37.7
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65 years and older
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Race
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278
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88.8
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23
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7.3
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12
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3.8
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Notes
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Did participants fail previous treatment? ... Yes ... anticholinergics
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Study years 2005-2008
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Trial name (if given) ND
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Does this paper cite a previous paper from the same study? NO
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Baseline Characteristics
Question OnabotulinumtoxinA 50 units Placebo OnabotulinumtoxinA 100 units OnabotulinumtoxinA 150 units OnabotulinumtoxinA 200 units OnabotulinumtoxinA 300 units Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 57 44 54 49 53 53 313
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50 37 48 40 47 50 272
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7 7 6 9 6 6 41
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Personal, lack of efficacy, lost to follow-up, ADRs, protocol violation, other
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure OnabotulinumtoxinA 50 units Placebo OnabotulinumtoxinA 100 units OnabotulinumtoxinA 150 units OnabotulinumtoxinA 200 units OnabotulinumtoxinA 300 units


0 weeks

N Analyzed 57 44 54 49 53 56
proportion 0 0 0 0 0 0


12 weeks

N Analyzed 57 44 54 49 53 56
proportion 29.8 15.9 37 40.8 50.9 57.1


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Low RoB
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RCT:.....Blinding of PATIENTS Low RoB
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low RoB
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner Yes
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Not Applicable
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ALL.....Other issues Not Applicable
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.