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Study Title and Description

Combined Vaginal Pelvic Floor Electrical Stimulation (PFS) and Local Vaginal Estrogen for Treatment of Overactive Bladder (OAB) in Perimenopausal Females. Randomized Controlled Trial (RCT).



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 Combined Vaginal Pelvic Floor Electrical Stimulation (PFS) and Local Vaginal Estrogen for Treatment of Overactive Bladder (OAB) in Perimenopausal Females. Randomized Controlled Trial (RCT).
Author Abdelbary AM., El-Dessoukey AA., Massoud AM., Moussa AS., Zayed AS., Elsheikh MG., Ghoneima W., Abdella R., Yousef M.
Country Department of Urology, Beni-Suef University, Beni-Suef, Egypt. Electronic address: ahmedabdelbary2010@hotmail.com.
Year 2015
Numbers Pubmed ID: 26135813

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 electrical stimulation pelvic floor electrical stimulation
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2 vaginal estrogen
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3 electrical stimulation + vaginal estrogen
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Egypt
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Funding source Explicitly not industry funded
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Inclusion criteria >=40yo without UTI, SUI, prior anti-incontinence or pelvic surgery, anti-incontinence meds (for at least 3 months), or malignancy
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Exclusion criteria none listed, opposite of inclusion
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UI type 100
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The primary outcome was improvement in urgency incontinence
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0
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0
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Age 48.5
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mean
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6
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40-70
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Men included 0
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Special populations
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80
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postmenopausal
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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 2010-2014
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Trial name (if given)
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Does this paper cite a previous paper from the same study? no
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Baseline Characteristics
Question electrical stimulation vaginal estrogen electrical stimulation + vaginal estrogen Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 105 105 105 315
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105 105 105 315
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105
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure electrical stimulation vaginal estrogen electrical stimulation + vaginal estrogen Comparison Measure ERROR vs. ERROR


0 months

N Analyzed 105 105 105 P-Value 0.6
Mean 0.5 0.6 0.5
SD 0.8 0.9 0.8
SE


6 months

N Analyzed 105 105 105 P-Value 0.000
Mean 0.4 0.4 0.09
SD 0.6 0.6 0.28
SE
Within-Arm Comparisons
Comparison Measure electrical stimulation vaginal estrogen electrical stimulation + vaginal estrogen
0 months vs. 6 months P-Value .000 .045 .158


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear 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.