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Study Title and Description

Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence.



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 Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence.
Author Castellani D., Saldutto P., Galica V., Pace G., Biferi D., Paradiso Galatioto G., Vicentini C.
Country University of L'Aquila, Urology Unit, Teramo Hospital, Teramo, Italy.
Year 2015
Numbers Pubmed ID: 26043913

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Pelvic floor muscle training + electrical stimulation + Biofeedback
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2 Pelvic floor muscle training + electrical stimulation + Biofeedback + Estriol
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Italy
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Funding source Not reported
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Inclusion criteria postmenopausal women with SUI
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Exclusion criteria previous surgical treatment for SUI or prolapse, urge incontinence <= POP-Q, severe hepatic disease, breast or uterine cancer, thromboembolic diseases, abnormal uterine bleeding, BMI >=30 kg/m3
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UI type
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100
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Age 55
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mean
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5.7
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Men included 0
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Special populations 72
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100
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Race 72
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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?
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Baseline Characteristics
Question Pelvic floor muscle training + electrical stimulation + Biofeedback Pelvic floor muscle training + electrical stimulation + Biofeedback + Estriol Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 37 35
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35 34
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2 1
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lost to followup discontinued treatment
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Notes No data entered.



Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB not reported
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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
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.