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Study Title and Description

Cycling Versus Continuous Mode In Neuromodulator Programming: A Crossover, Randomized, Controlled 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 Cycling Versus Continuous Mode In Neuromodulator Programming: A Crossover, Randomized, Controlled Trial.
Author Beer GM., Gurule MM., Komesu YM., Qualls CR., Rogers RG.
Country -- Not Found --
Year 2017
Numbers Pubmed ID: 27501593

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 cycling neuromodulation
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2 continuous neuromodulation
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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 Not reported
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Inclusion criteria Women who were eligible for neuromodulation surgery, over 21 years old, not currently pregnant or planning on becoming pregnant
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Exclusion criteria
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UI type
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100
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Age 66.5
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mean
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12
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Men included 0
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Special populations 23
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100
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Race
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8
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35
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3
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12
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10
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43
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2
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9
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American Indian
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Notes
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Did participants fail previous treatment? ... Yes ... 48% with prior UI procedures
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Study years 2012-2014
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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 cycling neuromodulation continuous neuromodulation Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 23
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23
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0
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Notes crossover trial
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Results & Comparisons


Results Data
Outcome: Incontinence Severity Index      Population: All Participants
Time Point Measure cycling neuromodulation continuous neuromodulation


3 months

N Analyzed 23 23
Counts 23 23


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) High 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? No
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Quality Rating
No quality rating data was found.