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Study Title and Description

Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device.



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 Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device.
Author Lovatsis D., Best C., Diamond P.
Country Division of Urogynaecology and Reconstructive Pelvic Surgery, Mount Sinai Hospital and University of Toronto, 700 University Avenue, Room 8-814, Toronto, ON, Canada, M5G 1Z5. dlovatsis@mtsinai.on.ca.
Year 2017
Numbers Pubmed ID: 27438055

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Uresta
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2 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Canada
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Funding source Explicitly not industry funded
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Inclusion criteria urodynamically proven SUI, SUI having moderate to severe impact on life
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Exclusion criteria mixed incontinence where urgency incontinence was predominant symptom, vaginal prolapse, post-voidal residual volume > 100 ml, hematuria, undiagnosed vaginal bleeding, pregnancy, past surgery for incontinence or prolapse, failed use of incontinence pessary, physical inability to perform activities included in pad test
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UI type
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100
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Age 50.95
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mean
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9.48
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Men included 0
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Special populations
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100
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Race
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100
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2011-2013
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Trial name (if given) SURE study
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question Uresta Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 18 18 36
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18 18 36
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0 0 0
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Uresta Placebo Comparison Measure ERROR vs. ERROR


Enter a numeric value or title (required) years

N Analyzed 18 18 P-Value 0.01
Mean
Counts 12 4
Outcome: Cure etc.      Population: All Participants
Time Point Measure Uresta Placebo


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N Analyzed 14 17
Counts 9 2


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
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
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