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Study Title and Description

The concomitant use of fesoterodine and topical vaginal estrogen in the management of overactive bladder and sexual dysfunction 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 The concomitant use of fesoterodine and topical vaginal estrogen in the management of overactive bladder and sexual dysfunction in postmenopausal women.
Author Chughtai B., Forde JC., Buck J., Asfaw T., Lee R., Te AE., Kaplan SA.
Country Department of Urology, Weill Cornell Medical College/New York Presbyterian Hospital, NY, USA bic9008@med.cornell.edu.
Year 2016
Numbers Pubmed ID: 26883688

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 fesoterodine plus topical vaginal estrogen
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2 fesoterodine
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries US
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Funding source Industry funded/industry provided materials
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Inclusion criteria postmenopausal women with a history of over-active bladder symptoms for at least 3 months, including an average of 8 or more micturitions per 24 h and at least one urgency incontinence episode per 24 h recorded in 3 day bladder diaries at baseline
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Exclusion criteria chronic urologic inflammation, uncontrolled narrow angle glaucoma, recurrent urinary tract infection, significant stress incontinence, partner with sexual dysfunction, an anatomic disorder of sexual function, a recent major gynaecological surgery, abnormal cervical smear results, history of gynaecological malignancy, and/or uncontrolled hypertension
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UI type
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100
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Age 55.4
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mean
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ND
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40.7-66.6
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Men included 0
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Special populations 23
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100
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Race 23
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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 ND
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Trial name (if given) ND
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Does this paper cite a previous paper from the same study? NO
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Baseline Characteristics
Question fesoterodine plus topical vaginal estrogen fesoterodine Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 11 12 23
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9 9 18
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3 2 5
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adverse effects adverse effects
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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 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 Yes
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Not Applicable
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ALL.....Other issues Not Applicable
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.