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Study Title and Description

Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care.



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 Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care.
Author Wiegersma M., Panman CM., Kollen BJ., Berger MY., Lisman-Van Leeuwen Y., Dekker JH.
Country University of Groningen, University Medical Center Groningen, Department of General Practice, FA21, PO Box 196, 9700 AD Groningen, Netherlands.
Year 2014
Numbers Pubmed ID: 25533442

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Pelvic floor muscle training
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2 Watchful waiting
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Netherlands
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Funding source Explicitly not industry funded
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Inclusion criteria Women aged 55 years or over with symptomatic mild pelvic organ prolapse.
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Exclusion criteria Current prolapse treatment or treatment in the previous year, pelvic organ malignancy, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.
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UI type
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100
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pelvic organ prolapse
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Age 64.25
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mean
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6.66
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Men included 0
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Special populations
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287
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100
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Race 287
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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 2009, 2012
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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 Pelvic floor muscle training Watchful waiting Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 145 142 287
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114 125 239
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31 14 45
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Personal circumstances, lack of motivation, disappointing results, PFMT too time consuming, moved away, unknown Personal circumstances, lack of motivation, disappointing results, PFMT too time consuming, moved away, unknown Personal circumstances, lack of motivation, disappointing results, PFMT too time consuming, moved away, unknown
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Notes No data entered.



Results & Comparisons


Results Data
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure ERROR vs. ERROR


3 months

N Analyzed 117 127 -11.0
Mean 46.9 51.3 -16.6
SD 37.4 29.7 -5.4
<0.0001
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 118 129 -2.6
Mean 10.5 11.4 -4.9
SD 12.3 11.3 -0.4
0.024
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 118 128 -1.4
Mean 10.5 13.6 -3.7
SD 12.3 12.7 0.8
0.209
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 118 129 -5.0
Mean 22.8 26.3 -8.6
SD 17.2 15.5 -1.4
0.007
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 110 120 0.03
Mean 18.0 11.7 -0.5
SD 36.1 23.7 1.1
0.478
P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 115 124 <0.001
proportion 0.61 0.08
count 70 10
P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 115 124 <0.001
proportion 0.37 0.85
count 43 106
P-Value
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure Pelvic floor muscle training Watchful waiting Comparison Measure Pelvic floor muscle training vs. Watchful waiting


3 months

N Analyzed 115 124 0.270
proportion 0.02 0.06
count 2 8


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") Unclear 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.