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Study Title and Description

Tolterodine ER reduced increased bladder wall thickness in women with overactive bladder. A randomized, placebo-controlled, double-blind, parallel group study.



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 Tolterodine ER reduced increased bladder wall thickness in women with overactive bladder. A randomized, placebo-controlled, double-blind, parallel group study.
Author Bray, R., Cartwright, R., Cardozo, L., Hill, S., Guan, Z., Khullar, V.
Country Department of Urogynaecology, St Marys Hospital, Imperial NHS Trust, Paddington, London, UK.
Year 2017
Numbers Pubmed ID: 28407338

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Tolterodine extended release
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2 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries United Kingdom
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Funding source Industry funded/industry provided materials
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Inclusion criteria Agedā‰„18 years, had OAB symptoms for at least 6 months prior to entering the study, and had a BWT of at least 5 mm and post-micturition volume of less than 50 mL at screening.
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Exclusion criteria Subjects could not be taking any anticholinergic drug or receiving any treatment for OAB. Women with significant SUI and women experiencing or with a history of urinary tract infection were also excluded from the study.
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UI type 100
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Directionality Prospective
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Age 47
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mean
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11.4
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nd
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Men included 0
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Special populations nd
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100
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Race
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30
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81
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4
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11
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1
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3
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2
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5
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2004, 2006
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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 Tolterodine extended release Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 37 42 79
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31 34 65
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6 8 14
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AE, subject defaulted AE, subject defaulted AE, subject defaulted
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Notes No data entered.



Results & Comparisons


Results Data
Mean Difference 95% CI low 95% CI high
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine extended release Placebo Comparison Measure Tolterodine extended release vs. Placebo


12 weeks

N Analyzed 30 37 -1.3
Mean -2.1 -0.7 -2.3
SD 2.03 2.5 -0.4
Mean Difference 95% CI low 95% CI high
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine extended release Placebo Comparison Measure Tolterodine extended release vs. Placebo


12 weeks

N Analyzed 30 37 -0.7
Mean -1.5 -0.5 -1.6
SD 2.2 1.7 0.2
Mean Difference 95% CI low 95% CI high
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine extended release Placebo Comparison Measure Tolterodine extended release vs. Placebo


12 weeks

N Analyzed 30 37 -0.7
Mean -2.3 -1.4 -1.8
SD 2.9 2.0 0.4
Mean Difference 95% CI low 95% CI high
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine extended release Placebo Comparison Measure Tolterodine extended release vs. Placebo


12 weeks

N Analyzed 30 37 -35.7
Mean 0.8 40.6 -108.2
SD 61.5 189.0 36.7


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 Low 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) High 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?
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Quality Rating
No quality rating data was found.