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Study Title and Description

Effects of intravaginal estriol and pelvic floor rehabilitation on urogenital aging in postmenopausal women.



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 Effects of intravaginal estriol and pelvic floor rehabilitation on urogenital aging in postmenopausal women.
Author Capobianco G., Donolo E., Borghero G., Dessole F., Cherchi PL., Dessole S.
Country Urogynecology Unit, Gynecologic and Obstetric Clinic, University of Sassari, Viale San Pietro 12, 07100 Sassari, Italy. capobsass@tiscali.it
Year 2012
Numbers Pubmed ID: 21706345

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Estriol + pelvic floor muscle training + electrical stimulation
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2 Estriol
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Sardinia
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Funding source Explicitly not industry funded
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Inclusion criteria urinary stress incontinence, vaginal atrophy, and histories of recurrent urinary tract infections. None received estrogen treatment prior to the study.
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Exclusion criteria pathologies or anatomical lesions of the urogenital tract such as uterovaginal prolapse, cystocele, and rectocele of grade II or III, severe systemic disorders, thromboembolic diseases, biliary lithiasis, previous breast or uterine cancer, abnormal uterine bleeding, and body mass index (BMI) >= 25 kg/m2
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UI type
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100
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direct visualization of loss of urine from the urethra during the standard stress test and by urodynamic investigation.
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Age 57.8
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mean
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4.5
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Men included 0
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Special populations 206
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100
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Race
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203
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98.5
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Notes Despite everyone having objective SUI based on the inclusion criteria, only 88/103 in the intervention group have self-reported SUI. This affects the results.
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Did participants fail previous treatment? Not reported/unclear
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Study years 2005-2010
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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 Estriol + pelvic floor muscle training + electrical stimulation Estriol Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 103 103 206
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103 103 206
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9 11 20
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5 discomfort during vaginal treatment; 4 localized adverse reactions, such as vaginal irritation and burning 6 discomfort during vaginal treatment; 5 localized adverse reactions, such as vaginal irritation and burning 11 discomfort during vaginal treatment; 9 localized adverse reactions, such as vaginal irritation and burning
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Estriol + pelvic floor muscle training + electrical stimulation Estriol Comparison Measure Estriol + pelvic floor muscle training + electrical stimulation vs. Estriol


0 months

N Analyzed 103 103 P-Value
Counts 83 103


6 months

N Analyzed 103 103 Net P value <0.01
Counts 81 10
Outcome: Cure etc.      Population: All Participants
Time Point Measure Estriol + pelvic floor muscle training + electrical stimulation Estriol


6 months

N Analyzed 83 103
Counts 61 10


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
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.