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Study Title and Description

Prospective Randomized Crossover Trial Comparing Continuous and Cyclic Stimulation in InterStim Therapy.



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 Prospective Randomized Crossover Trial Comparing Continuous and Cyclic Stimulation in InterStim Therapy.
Author Price DM., Noblett K.
Country From the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Ob/Gyn, University of California, Irvine, Orange, CA.
Year -- Not Found --
Numbers Pubmed ID: 26506165

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Continuous Stimulation using InterStim implant
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2 Cyclic Stimulation using InterStim implant
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Design Details
Question... Follow Up Answer Follow-up Answer
Country/countries United States
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Funding source Not reported
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Inclusion criteria newly implanted with InterStim, have undergone a successful implantation and test period for Interstim
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Exclusion criteria previous InterStim implantation, no InterStim device
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UI type
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100
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Directionality Prospective
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Age 64.6
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mean
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11.6
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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 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 Continuous Stimulation Cyclic Stimulation Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 21 21 42
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18 14 32
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3 7 10
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9 withdrew due to inability to return for study visits, 1 from rapid reduction of efficacy
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure Continuous Stimulation Cyclic Stimulation


Enter a numeric value or title (required) years

N Analyzed
Counts
P-Value
Outcome: No. of pads used      Population: All Participants Between-Arm Comparisons
Time Point Measure Continuous Stimulation Cyclic Stimulation Comparison Measure Continuous Stimulation vs. Cyclic Stimulation


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N Analyzed 32 32 0.94
Mean 1.6 1.7
SD 1.5 1.3
Outcome: Urgency Severity      Population: All Participants
Time Point Measure Continuous Stimulation Cyclic Stimulation


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N Analyzed
Mean
SD
n mild wet
n moderate wet
n severe wet
P-Value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Continuous Stimulation Cyclic Stimulation Comparison Measure ERROR vs. ERROR


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N Analyzed 32 32 0.17
Mean 2.5 2.1
SD 2.6 2.8


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 High RoB pts could not be blinded, stimulation from device felt.
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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 surgeon blinded until after device implanted
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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? No unsure how many cycles a day for cyclin group
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Quality Rating
No quality rating data was found.