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Study Title and Description

Behavioral Intervention Program versus Vaginal Cones on Stress Urinary Incontinence and Related Quality of Life: A Randomized Clinical Trial.



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 Behavioral Intervention Program versus Vaginal Cones on Stress Urinary Incontinence and Related Quality of Life: A Randomized Clinical Trial.
Author Golmakani N., Khadem N., Arabipoor A., Kerigh BF., Esmaily H.
Country Master of Science in Midwifery, Lecturer and Faculty Member of Department of Midwifery, School of Nursing & Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Year 2014
Numbers Pubmed ID: 24498480

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Behavioral intervention program
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2 Vaginal cones
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Iran
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Funding source Explicitly not industry funded
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Inclusion criteria Women, 25-65 yo, proven SUI
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Exclusion criteria Chronic degenerative diseases, vaginitis, pregnancy, active or recurrent UTIs, advanced genital prolapse, cardiac pacemakers
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UI type
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100
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>=3 episodes/wk
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Age 45.5
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mean
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4.6
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25-65 (eligibility)
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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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Iranian, implied
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2008-2009
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Trial name (if given)
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Does this paper cite a previous paper from the same study? no
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Baseline Characteristics
Question Behavioral intervention program Vaginal cones Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 60
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51
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9
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Candida infection (3 vag cone), failure to participate (4 behavioral), irregular bleeding (2 total)
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Notes Dropouts for intervention-specific reasons.
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Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Behavioral intervention program Vaginal cones


0 weeks

N Analyzed 26 25
n mild 6 5
n moderate 14 13
n severe 6 7


12 weeks

N Analyzed 26 25
n mild 17 14
n moderate 7 8
n severe 2 3
Within-Arm Comparisons
Comparison Measure Behavioral intervention program Vaginal cones
ERROR vs. ERROR P-Value 0.02 0.04
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure Behavioral intervention program Vaginal cones


0 weeks

N Analyzed 26 25
Mean 1.2 1.0
SD 1.3 1.0
SE


12 weeks

N Analyzed 26 25
Mean 0.5 0.8
SD 0.5 0.7
SE
Outcome: Leakage test: Other (placeholder)      Population: All Participants
Time Point Measure Behavioral intervention program Vaginal cones


0 weeks

N Analyzed 26 25
Mean 16.2 16.6
SD 4.5 4.8
SE


12 weeks

N Analyzed 26 25
Mean 3.2 6.1
SD 1.5 2.5
SE
Outcome: Leakage test: Pad test      Population: All Participants
Time Point Measure Behavioral intervention program Vaginal cones


0 weeks

N Analyzed 26 25
Mean 35.8 36.1
SD 6.8 7.1
SE


12 weeks

N Analyzed 26 25
Mean 12.8 19.5
SD 3.8 5.2
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment High RoB
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis High 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) High RoB Loss to f/up due to intervention-specific reasons; 15% overall
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions High RoB Loss to f/up due to non-adherence (4/60)
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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
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.