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Study Title and Description

Rectal balloon training as an adjunctive method for pelvic floor muscle training in conservative management of stress urinary incontinence: a 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 Rectal balloon training as an adjunctive method for pelvic floor muscle training in conservative management of stress urinary incontinence: a pilot study.
Author Roongsirisangrat S., Rangkla S., Manchana T., Tantisiriwat N.
Country Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Year 2012
Numbers Pubmed ID: 23140031

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 PFMT
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2 PFMT + rectal balloon
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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 Age 25-70 years; SUI
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Exclusion criteria Mixed UI; received medication alleviating symptoms within 3 weeks, impaired either recent or recall memory; central nervous system disorders; urinary tract infection; anorectal disease; pelvic organ prolapse; rectal prolapse; previous pelvic trauma; pregnant; postpartum
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UI type
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100
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Age 49.6
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mean
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8.7
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30, 64
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Men included 0
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Special populations 26
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100
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Race 26
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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 2010-2011
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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 PFMT + rectal balloon Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 14 14 26
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13 13 24
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1 1 2
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LTF LTF LTF
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Satisfaction with intervention      Population: All Participants
Time Point Measure PFMT PFMT + rectal balloon


0 weeks

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6 weeks

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Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence High RoB 'quasi randomized' - determined by order of registration into trial
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RCT:.....Allocation concealment Unclear RoB No data
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RCT:.....Blinding of PATIENTS High RoB unblinded
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RCT.....Intention-to-treat-analysis High RoB analysis of treatment completers only
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB unblinded
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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.