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Study Title and Description

A randomized, controlled clinical trial of a novel intravesical pressure attenuation device for the treatment of stress urinary incontinence



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 randomized, controlled clinical trial of a novel intravesical pressure attenuation device for the treatment of stress urinary incontinence
Author Rovner E, Dmochowski R, Leach G, Jayne C, Snyder J
Country
Year 2013
Numbers Pubmed ID: 23796570

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Intravesical pressure attenuation device
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2 sham device
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries U.S.
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Funding source Industry funded/industry provided materials
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Inclusion criteria female subjects >= 18 with SUI symptoms (demonstrated either urodynamically or by cough test)
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Exclusion criteria Pregnant, Bladder infection, History of recurrent UTIs, intrinsic sphincter deficiency, artificial urinary sphincter or surgical procedure for incontinence during the past 6 months, Cystocele with bladder descent below mid-vagina during straining, Undergoing or anticipating a course of pelvic radiation therapy, Severe pelvic fibrosis from previous radiation therapy,  Urosepsis within previous 30 days, Presence of gross hematuria and/or blood clots in the urine
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UI type
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100
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Age 52.6
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mean
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11.3
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Men included 0
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Special populations
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23
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13.9
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vigorous activity level
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Race 166
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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 nd
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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 Intravesical pressure attenuation device sham device Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 112 54 166
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66 49 115
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46 5 51
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Device or procedure issue 19 (11) Tolerability 17 (10) UTI 4 (2) Personal decision 3 (2) Study too burdensome 2 (1) Now ineligible 2 (1) Unsatisfactory therapeutic effect 2 (1) Pt concern over calcification 1 (1) Pt concern over hematuria 1 (1)
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Notes dropout reasons not given by arm
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Results & Comparisons


Results Data
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Intravesical pressure attenuation device sham device Comparison Measure Intravesical pressure attenuation device vs. sham device


6 months

N Analyzed 112 54 P-Value 0.455
Counts 32 12
Percentage 28.6 22.2
Outcome: Other UI measure (placeholder)      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 112 54
Counts 36 8
Percentage 32 15
Outcome: Adverse events      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed
Counts
Percentage
Outcome: Leakage test: Pad test      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 34 12
Percentage 51.5 24.5
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 43 15
Percentage 65.45 31.25
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 22 8
Percentage 33.85 16.70
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 29 12
Percentage 43.2 24.1
Outcome: Bladder control, subjective      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 48 22
Percentage 72.7 44.9
Outcome: Other UI measure (placeholder)      Population: All Participants
Time Point Measure Intravesical pressure attenuation device sham device


6 months

N Analyzed 66 49
Counts 20 6
Percentage 30.3 12.2


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 High RoB 11% dropout for device or proceedure issue. Not included in analysis
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low RoB
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ALL.....Incomplete results data (attrition bias) High RoB differential dropout
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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
No quality rating data was found.