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Study Title and Description

A phase 2, randomized, double-blind, efficacy and safety study of oxybutynin vaginal ring for alleviation of overactive bladder symptoms in women



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 A phase 2, randomized, double-blind, efficacy and safety study of oxybutynin vaginal ring for alleviation of overactive bladder symptoms in women
Author Gittelman, M, Weiss, H, Seidman, L
Country
Year 2014
Numbers Pubmed ID: 24231837

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 Oxybutynin vaginal ring 4 mg
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2 Oxybutynin vaginal ring 6 mg
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3 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries US, Canada
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Funding source Industry funded/industry provided materials
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Inclusion criteria ≥18 years of age; OAB for ≥6 months; pure or predominant urinary urge incontinence (UUI); willing to discontinue all current OAB medications for 2 weeks prior to a placebo run-in period.
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Exclusion criteria Pure or predominant stress incontinence, insensate incontinence, or overflow urinary incontinence; urinary retention;uncontrolled narrow-angle glaucoma; hypersensitivity to Oxy or silicone; pregnancy/delivery in last 6 months; infections or conditions of urinary tract, bladder, vagina, or cervix that precluded VR placement or visual inspection; cervical dysplasia or any atypical Pap smear findings; known HIV positivity; history of any other medical conditions that could worsen with Oxy administration or VR use; current use of vaginal contraceptives or devices; initiation of hormone therapy within prior 3 months; prior Oxy response failure; and any use in the previous 3 months of other investigational drugs.
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UI type
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0
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100
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Ten or more urge incontinence episodes/week AND average urinary frequency of 8 or more voids per 24 hours, AND total voided volume of 3 Liters or less per 24 hours
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Age 57
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mean
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11.49
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21.3
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85.7
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Men included 0
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Special populations 323
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100
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Race
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254
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78.6
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54
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16.7
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14
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4.3
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1
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0.3
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2004-2006
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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 Oxybutynin vaginal ring 4 mg Oxybutynin vaginal ring 6 mg Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 143 147 155 720
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115 96 112 323
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Patients had to meet all 3 OAB criteria after placebo run-in phase Patients had to meet all 3 OAB criteria after placebo run-in phase Patients had to meet all 3 OAB criteria after placebo run-in phase 54
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12 24 18
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Oxybutynin vaginal ring 4 mg Oxybutynin vaginal ring 6 mg Placebo Comparison Measure Oxybutynin vaginal ring 4 mg vs. Placebo Oxybutynin vaginal ring 6 mg vs. Placebo


0 weeks

N Analyzed 115 96 112 P-Value
Counts 0 0 0


12 weeks

N Analyzed 115 96 112 P-Value 0.026 0.027
Counts 25.2 26 13.4
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure Oxybutynin vaginal ring 4 mg Oxybutynin vaginal ring 6 mg Placebo Comparison Measure Oxybutynin vaginal ring 4 mg vs. Placebo Oxybutynin vaginal ring 6 mg vs. Placebo


0 weeks

N Analyzed 115 96 112
Mean 28.34 26.52 28.25
SD
SE


12 weeks

N Analyzed 115 96 112 P-Value
Mean 16.45 14.3 14.5
SD
SE
Within-Arm Comparisons
Comparison Measure Oxybutynin vaginal ring 4 mg Oxybutynin vaginal ring 6 mg Placebo
12 weeks vs. 0 weeks Mean Difference -16.8 -16.7 -13.8
SD 16.45 14.3 14.5
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin vaginal ring 4 mg Oxybutynin vaginal ring 6 mg Placebo


0 weeks

N Analyzed
Mean
SD
SE


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)? Yes
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ALL.....Other issues No Data
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.