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Study Title and Description

Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study.



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 Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study.
Author Ong TA., Khong SY., Ng KL., Ting JR., Kamal N., Yeoh WS., Yap NY., Razack AH.
Country Division of Urology, Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. Electronic address: ongta2005@yahoo.co.uk.
Year 2015
Numbers Pubmed ID: 26142713

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 PFMT + biofeedback pelvic floor muscle training + biofeedback with Vibrance Kegel Device
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2 PFMT pelvic floor muscle training
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Malaysia
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Funding source Industry funded/industry provided materials
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Inclusion criteria Female suffering predominantly from SUI
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Exclusion criteria Previous incontinence surgery; concomitant medical treatment for urinary incontinence, UTI, neurologic or psychiatric disease
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UI type
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100
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says SUI is inclusion, but urge is accepted and there is no numeric breakdown of these participants
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Age 51.9
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mean
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12.7
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Men included 0
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Special populations
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23
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57.5
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menopause
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Race
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40
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100
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Malay (n=22), Chinese (n=9), Indian (n=9)
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2011-2013
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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 PFMT + biofeedback PFMT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 21 19 40
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21 16 37
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0 3 3
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LTF (n=3) LTF (n=3)
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure PFMT + biofeedback PFMT


16 weeks

N Analyzed 16 16
Counts 13 13
Proportion 81.3 81.3
Outcome: Other patient-centered outcomes (placeholder)      Population: All Participants
Time Point Measure PFMT + biofeedback PFMT


16 weeks

N Analyzed 21 16
Counts 18 11
Proportion 85.7 68.8
Outcome: Cure etc.      Population: All Participants
Time Point Measure PFMT + biofeedback PFMT


16 weeks

N Analyzed 21 16
Counts 12 10
Proportion 57.1 62.5
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure PFMT + biofeedback PFMT


16 weeks

N Analyzed
Counts
Proportion


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB concealment not described
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis High RoB dropouts not analyzed
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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 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 Yes Potentially a typo, but results for certain outcomes report more dropouts than participant flow
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.