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Study Title and Description

Long-term sacral magnetic stimulation for refractory 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 Long-term sacral magnetic stimulation for refractory stress urinary incontinence.
Author Tsai PY., Wang CP., Hsieh CY., Tsai YA., Yeh SC., Chuang TY.
Country Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Year 2014
Numbers Pubmed ID: 25073008

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 sacral magnetic stimulation
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2 sham (control)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Taipei
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Funding source Explicitly not industry funded
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Inclusion criteria (1) a diagnosis of SUI, with or without detrusor overactivity, confirmed by urodynamic results; (2) an SUI history of at least 6 months, which remained refractory after at least 1 month of first-line management; (3) no history of surgery or hormone replacement therapy for SUI; (4) an absence of severe pelvic prolapse (>grade 3 prolapse or Qmax<15mL/s); and (5) no contraindication for SMS, such as a pacemaker or metallic device. No patients received anticholinergic medication in the 2 weeks before participation or during the follow-up period.
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Exclusion criteria
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UI type 0
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70.5
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29.4
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Directionality Prospective
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Age 63.3
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mean
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14.4
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Men included 0
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Special populations
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27
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79.
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menopause
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Race
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100
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Notes
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Did participants fail previous treatment? ... Yes ... all must have failed at least one month of first line therapy
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Study years 2010-2012
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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 sacral magnetic stimulation sham (control) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 20 20 40
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2 12 30
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18 8 10
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure sacral magnetic stimulation sham (control)


18 weeks

n cured 44.4% NR but "non-significant improvement"
n improved 77.7% NR but "non-significant improvement"


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Unclear 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 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
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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
No quality rating data was found.