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Study Title and Description

Comparison of Side Effects of Solifenacin Vs Tolteridine in Patients with 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 Comparison of Side Effects of Solifenacin Vs Tolteridine in Patients with Urinary Incontinence
Author Butt, F
Country
Year 2016
Numbers

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Solifenacin Succinate
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2 Tolterodine
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Pakistan
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Funding source Not reported
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Inclusion criteria Patients having complaint of urinary incontinence, complaints of nocturia, and/or complaints of frequency (the number of times a women voids during her waking hours. Normally it is between 4-7 voids per day)
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Exclusion criteria Patients with urinary tract infection (on urine complete examination), fistula (history of continuous dribbling of urine), pregnancy, uterovaginal prolapspe, and/or diabetes (BSF >126 mg/dl and BSR>200 mg/dl).
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UI type
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100
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Age 57.34
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mean
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11.54
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nd
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Men included 0
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Special populations 830
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100
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Race 830
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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)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question Solifenacin Succinate Tolterodine Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 415 415 830
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415 415 830
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0 0 0
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events      Population: All Participants
Time Point Measure Solifenacin Succinate Tolterodine


3 months

N Analyzed 415 415
count 123 101
proportion 0.2964 0.2434
P-Value
Outcome: Adverse events      Population: Dry Mouth Between-Arm Comparisons
Time Point Measure Solifenacin Succinate Tolterodine Comparison Measure Solifenacin Succinate vs. Tolterodine


3 months

N Analyzed 415 415 0.085
count 123 101
proportion 0.2964 0.2434
P-Value
Outcome: Adverse events      Population: Constipation Between-Arm Comparisons
Time Point Measure Solifenacin Succinate Tolterodine Comparison Measure Solifenacin Succinate vs. Tolterodine


3 months

N Analyzed 415 415 0.008
count 41 21
proportion 0.0988 0.0506


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 Unclear RoB
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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
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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? No
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Quality Rating
No quality rating data was found.