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Study Title and Description

Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study.



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 Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study.
Author Sokol ER., Karram MM., Dmochowski R.
Country Departments of Obstetrics and Gynecology, Stanford University, Stanford, California.
Year 2014
Numbers Pubmed ID: 24704117

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Hydrogel Polyacrylamide hydrogel bulking agent
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2 Collagen gel Contigen collagen gel (no longer available)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries USA, Canada
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Funding source Industry funded/industry provided materials
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Inclusion criteria Not stated "women who met study eligibility criteria were randomized"
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Exclusion criteria allergy to bovine collagen
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UI type
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100
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Age 58.5
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medan
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23.3-93.4
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They list this as median and range but the decimal points would be more consistent with means
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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 2008-2011
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Trial name (if given)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question Hydrogel Collagen gel Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 229 116 345
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201 102 303
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28 14 42
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Leakage test: Pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure Hydrogel Collagen gel Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 229 116 P-Value 0.0003
Value
Unit
Counts 105 48
Percentage 45.9 41.4
Outcome: Cure etc.      Population: All Participants
Time Point Measure Hydrogel Collagen gel


12 months

N Analyzed 183 90
Value 44 22
Unit
Counts
Percentage


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear 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") Unclear 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 No
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ALL....Were interventions adequately described? Yes
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Quality Rating
Guideline Used Overall Rating