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Study Title and Description

What is the success of drug treatment in urge urinary incontinence? What should be measured?



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 What is the success of drug treatment in urge urinary incontinence? What should be measured?
Author Dede H., Dolen İ., Dede FS., Sivaslioglu AA.
Country Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital, 1435. Sk. No: 4/2 Cukurambar, 06520 Ankara, Turkey. hulyadede@yahoo.com
Year 2013
Numbers Pubmed ID: 23086134

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Tolterodine Tolterodine 2mg twice daily
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2 Trospium Chloride Trospium 2mg twice daily
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3 Oxybutinin oxybutynin 5 mg three times daily
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Germany
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Funding source Explicitly not industry funded
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Inclusion criteria urge incontinence, mixed incontinence (motor component dominant with at least 1 unstable detrusor contraction with simultaneous urge or urge incontinence)
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Exclusion criteria stress incontinence primary diagnosis, urological or gynecological surgeries < 3 months before study start,untreated tachy-arrythmia, closed angle glaucoma, outflow obstruction of any etiology, myasthenia gravis, pregnancy and lactation, acute allergies or drug intolerance towards atropine, oxy- butynin, TCI, or any adjuvant contained in the tablets,other anticholinergics,tri-tetracyclic antidepressants, calcium antagonists (unless started at least 3 months before administration of the first dose of study medication) and b-sympathomimetics in the last 7 days before the first urodynamic assessment were not eligible. Disallowed concomitant medications were antihistamines, amantadine, quinidine,disopyramide.
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UI type 55.56
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detrussor instability
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44.44
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motor component dominant
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Age 51.83
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mean
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10.52
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Men included 0
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Special populations 90
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100
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Race 90
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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 2007-2008
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Trial name (if given)
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Does this paper cite a previous paper from the same study? yes
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Baseline Characteristics
Question Tolterodine Trospium Chloride Oxybutinin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 30 30 30 90
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30 30 30 90
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0 0 0 0
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure Tolterodine Trospium Chloride Oxybutinin


Enter a numeric value or title (required) years

N Analyzed 30 30 30
Percentage 87 67 80
n cured 7 3 2
n very much better 19 17 22
n no change 4 8 6
n worse 0 2 0


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
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low 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
Guideline Used Overall Rating