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Study Title and Description

A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors.



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 A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors.
Author Rutledge TL., Rogers R., Lee SJ., Muller CY.
Country Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA. Electronic address: trutledge@salud.unm.edu.
Year 2014
Numbers Pubmed ID: 24183730

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 Control
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries USA
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Funding source Not reported
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Inclusion criteria Age > 30 years old; history of uterine, cervical, ovarian, or vulvar cancer; attended the gynecologic oncology clinics for routine surveillance visits; any degree of urinary incontinence
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Exclusion criteria nd
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UI type
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70
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25
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Age 57
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mean
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7.2
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37, 79
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Men included 0
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Special populations 40
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100
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Race
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25
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62.5
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1
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2.5
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10
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25
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4
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10
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Native American
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Notes All participants had been disease- and treatment-free for at least one year and currently had no evidence of cancer.
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Did participants fail previous treatment? ... Some ... 10% PFMT prior incontinence treatment; 20% control prior incontinence treatment
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Study years nd
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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 Control Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 20 20 40
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17 19 36
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3 1 4
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LTF (n=3) LTF (n=1) LTF
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Notes No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure PFMT Control Comparison Measure PFMT vs. Control


12 weeks

N Analyzed 20 20 0.025
n much better 16 8
n no change 4 12


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
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High 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.