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Study Title and Description

Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial.



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 Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial.
Author Celiker Tosun O., Kaya Mutlu E., Ergenoglu AM., Yeniel AO., Tosun G., Malkoc M., Askar N., Itil IM.
Country Dokuz Eyl├╝l University, School of Physiotherapy and Rehabilitation, Turkey.
Year 2015
Numbers Pubmed ID: 25142280

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 PFMT Group 1 Participants in late reproductive age with regular menstrual cycles (STRAW stage j3) and participants in the early menopausal transition with variable cycle lengths,where consecutive cycle lengths differ by more than 7 days (STRAW stage j2).
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2 PFMT Group 2 Participants who had their final menstrual bleeding between 2 and 5 years ago (STRAW stage +1) and participants who went through the late menopausal transition with at least one intermenstrual interval of 60 days or more regardless of the early cycle of FSH levels (STRAW stage j1).
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3 PFMT Group 3 Participants who had their final menstrual bleeding more than 5 years ago (STRAW stage +2).
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type NRCS
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Country/countries Turkey
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Funding source Not reported
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Inclusion criteria UI diagnosed by a urogynecologist using analysis of urodynamics
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Exclusion criteria Pregnancy; history of spinal surgical operation; spinal or pelvic fracture; urinary tract infection; vaginal infection; nulliparity; known neurologic disorders; respiratory diseases; any endocrinologic diseases; smoking within the last 12 months; long-term illness; hormone therapy or oral contraceptive use within the last 6 months; age younger than 40 years; urge incontinence; hysterectomy; previous uterine pathology; high level or competitive physical training; recent weight loss (10%); menstruation at the time of assessment; undergone PFM training at a physiotherapy clinic within the last 2 years
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UI type
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49.5
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50.5
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Directionality Prospective
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Age 53.8
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mean
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10.4
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36-70
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Men included 0
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Special populations 103
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100
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Race 103
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100
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Notes The participants included in this study were separated into three groups according to the STRAW staging system, as follows (Fig. 1): Group 1 (G1): Participants in late reproductive age with regular menstrual cycles (STRAW stage j3) and participants in the early menopausal transition with variable cycle lengths, where consecutive cycle lengths differ by more than 7 days (STRAW stage j2). Group 2 (G2): Participants who had their final menstrual bleeding between 2 and 5 years ago (STRAW stage +1) and participants who went through the late menopausal transition with at least one intermenstrual interval of 60 days or more regardless of the early cycle of FSH levels (STRAW stage j1). Group 3 (G3): Participants who had their final menstrual bleeding more than 5 years ago (STRAW stage +2).
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Did participants fail previous treatment? Not reported/unclear
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Study years 2011-2014
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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 PFMT Group 1 PFMT Group 2 PFMT Group 3 Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 41 41 41 123
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41 32 30 103
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0 9 11 20
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nd nd Changes in their working conditions (n=12); health problems (n=8)
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Leakage test: Pad test      Population: All Participants
Time Point Measure PFMT Group 1 PFMT Group 2 PFMT Group 3


0 weeks

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12 weeks

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Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence
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RCT:.....Allocation concealment
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RCT:.....Blinding of PATIENTS
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RCT.....Intention-to-treat-analysis
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND")
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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)? Yes
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ALL.....Other issues Yes Does not seem that inclusion/exclusion criteria were adhered to
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.