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Study Title and Description

Short-term effect of adding pelvic floor muscle training to bladder training for female 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 Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial.
Author Kaya S., Akbayrak T., Gursen C., Beksac S.
Country Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Samanpazari, Ankara, Turkey, serapky@yahoo.com.
Year 2015
Numbers Pubmed ID: 25266357

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 BT+PFMT
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2 BT alone
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Turkey
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Funding source Explicitly not industry funded
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Inclusion criteria Female; having symptoms of SUI, UUI, or MUI; age>18 years; being free of UI medications for at least 4 weeks before the start of the study; and sufficient literacy to complete required forms and urinary diaries.
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Exclusion criteria Antenatal or postnatal women (up to 3 months after delivery), women who were unable to voluntarily contract their PFM, and women with persistent urinary tract infections, impaired mental state, pelvic organ prolapse (POP) past the vaginal introitus, neurological disorders, and who received concurrent or recent physiotherapy intervention (within the last year).
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UI type 15.2
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46.2
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38.6
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Age 48.7
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mean
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10.1
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Men included 0
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Special populations 132
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100
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Race 132
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100
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Notes
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Did participants fail previous treatment? No (explicitly treatment naive)
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Study years 2012-2014
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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 BT+PFMT BT alone Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 67 65 132
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56 52 108
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11 13 24
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Withdrew, family needs, hospitalization, unspecified pelvic pain, failed to contact or did not return Withdrew, family needs, hospitalization, unspecified pelvic pain, failed to contact or did not return Withdrew, family needs, hospitalization, unspecified pelvic pain, failed to contact or did not return
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Bladder control, subjective      Population: Worse
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Counts 0 0
Proportion 0 0
Outcome: Bladder control, subjective      Population: Unchanged
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Counts 0 9
Proportion 0 0.173
Outcome: Bladder control, subjective      Population: Improved
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Counts 33 40
Proportion 0.589 0.769
Outcome: Bladder control, subjective      Population: Cured
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Counts 23 3
Proportion 0.411 0.058
Outcome: Incontinence Severity Index      Population: All Participants
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Mean 6.0 0.0
Max 8.0 3.0
Min 4.0 0.0
Outcome: Incontinence Severity Index      Population: All Participants
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Mean 27.1 8.3
Max 41.6 33.3
Min 16.6 -4.1
Outcome: Incontinence Severity Index      Population: All Participants
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 52 56
Mean 23.8 7.1
Max 41.6 28.5
Min 9.5 -4.7
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 56 52
Mean 0.6 0.0
Max 1.3 1.0
Min 0.0 0.0
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure BT+PFMT BT alone


6 weeks

N Analyzed 56 52
Mean 2.8 2.8
Max 4.3 3.6
Min 1.6 1.4


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment High 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) 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 No
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.