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Study Title and Description

Effect of vaginal spheres and pelvic floor muscle training in women with 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 Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: a randomized, controlled trial.
Author Porta-Roda O., Vara-Paniagua J., Díaz-López MA., Sobrado-Lozano P., Simó-González M., Díaz-Bellido P., Reula-Blasco MC., Muñoz-Garrido F.
Country Service of Gynaecology and Obstetrics, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Year 2015
Numbers Pubmed ID: 25130167

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 + vaginal spheres
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2 Pelvic Floor Muscle Training
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Spain
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Funding source Industry funded/industry provided materials
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Inclusion criteria women aged 35–60 years of age with SUI or MUI, who had delivered vaginally at least once and had not previously performed pelvic floor exercises
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Exclusion criteria (1) were taking any medication that could interfere in urine retention; (2) had severe pelvic organ prolapse; (3) were obese; (4) showed suspicion of complicated urinary incontinence; (5) were pregnant or in a post-partum period of under 6 months; or (6) had participated in another clinical trial in the previous 30 days
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UI type
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100
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SUI or MUI
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Age nd
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Men included 0
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Special populations 65
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100
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Race 65
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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 2011
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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 + vaginal spheres Pelvic Floor Muscle Training Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 37 33 70
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35 30 65
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2 3 5
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1 lost to followup; 1 became pregnant lost to followup
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Bladder control, subjective      Population: All Participants
Time Point Measure Pelvic Floor Muscle Training + vaginal spheres Pelvic Floor Muscle Training


6 months

N Analyzed 35 30
Counts 29 18
Outcome: Bladder control, subjective      Population: All Participants
Time Point Measure Pelvic Floor Muscle Training + vaginal spheres Pelvic Floor Muscle Training


6 months

N Analyzed 35 30
Counts 32 21


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 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) Low RoB
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions High RoB compliance was <70% at beginning and <50% at end of study
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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? Yes
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Quality Rating
No quality rating data was found.