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Study Title and Description

Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies.



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 Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies.
Author Huebner M., Riegel K., Hinninghofen H., Wallwiener D., Tunn R., Reisenauer C.
Country Department of Obstetrics and Gynecology, University Hospital of Tuebingen, Germany.
Year 2011
Numbers Pubmed ID: 20848671

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 EMG biofeedback and electrical stimulation
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2 EMG biofeedback and dynamic electrical stimulation
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3 EMG biofeedback
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Germany
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Funding source Explicitly not industry funded
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Inclusion criteria clinically verified SUI and MUI with predominant SUI, ability to perform a voluntary pelvic floor contraction, age 18 or older, negative pregnancy test.
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Exclusion criteria cardiac pacemaker, non-contracting/non-functioning pelvic floor, stage 2 or greater prolapse, genital anomalies, urogyn surgery in the prior 2 months, participation in other studies, OAB or MUI with predominant OAB
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UI type
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100
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Age 49.8
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mean
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12.9
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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 2004-2006
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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 EMG biofeedback and electrical stimulation EMG biofeedback and dynamic electrical stimulation EMG biofeedback Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 36 36 36 108
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33 8 9 88
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3 28 27 allergic rxn, bowel tumor, 5 wanted surgery, 13 for "motivation problems"
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: No. of pads used      Population: All Participants
Time Point Measure EMG biofeedback and electrical stimulation EMG biofeedback and dynamic electrical stimulation EMG biofeedback


12 months

N Analyzed
Counts
Outcome: Leakage test: Pad test      Population: All Participants
Time Point Measure EMG biofeedback and electrical stimulation EMG biofeedback and dynamic electrical stimulation EMG biofeedback


12 weeks

N Analyzed
Counts


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence High RoB
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RCT:.....Allocation concealment Unclear RoB
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RCT:.....Blinding of PATIENTS Unclear RoB
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RCT.....Intention-to-treat-analysis High RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Unclear RoB
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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 High 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.