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Study Title and Description

Development of a pelvic floor muscle strength evaluation device.



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 Development of a pelvic floor muscle strength evaluation device.
Author Manonai J., Kamthaworn S., Petsarb K., Wattanayingcharoenchai R.
Country
Year 2015
Numbers Pubmed ID: 25920290

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 BF + PFMT biofeedback and pelvic floor muscle training
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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 Thailand
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Funding source Explicitly not industry funded
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Inclusion criteria SUI diagnosed according to the International Urogynecological Association (IUGA)/ International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction; leakage episode occurring more than once a week
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Exclusion criteria Pregnancy; previous pelvic surgery for urology or gynecology in the past year; concomitant treatment for SUI during the trial period; neurological or psychiatric disease; urinary tract infection; any severe disease such as malignancy
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UI type
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100
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Age 47.77
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mean
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7.08
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Men included 0
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Special populations 61
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100
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Race 61
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100
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Notes Study is re:development of testing device
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Did participants fail previous treatment? Not reported/unclear
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Study years 2012-2013
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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 BF + PFMT PFMT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 29 32 61
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28 31 59
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1 1 2
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protocol was found to be too demanding (n=1), LTF (n=1)
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure BF + PFMT PFMT


16 weeks

N Analyzed 29 32
Counts 20 25


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
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RCT.....Intention-to-treat-analysis Low RoB Baseline observations carried forward for dropouts
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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) 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.