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Study Title and Description

Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: a 12-week single blind 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 Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: a 12-week single blind randomized controlled trial.
Author Oldham J., Herbert J., McBride K.
Country Centre for Rehabilitation Science, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom. jackie.oldham@manchester.ac.uk
Year 2013
Numbers Pubmed ID: 23023996

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 exercise
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2 Pelviva + exercise
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries UK
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Funding source Industry funded/industry provided materials
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Inclusion criteria Women (18–65 years of age) with self-reported stress, urge, or mixed incontinence
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Exclusion criteria Pregnancy or a baby in the last 3 months. Recent abdominal surgery and previous or current active therapy for pelvic malignancy. Implanted pacemaker. Manual dexterity insufficient to place the device. Previous treatment for incontinence. Presence of a neurological condition such as MS or Parkinson’s disease.
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UI type 11
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28
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61
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Age 48.1
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mean
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8.7
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18, 65
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Men included 0
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Special populations 124
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100
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Race 124
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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 nd
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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 exercise Pelviva + exercise Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 60 64 124
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46 49 95
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14 15 29
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dropouts had similar characteristics to each other and those remaining in the study
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure exercise Pelviva + exercise


12 weeks

N Analyzed 49 46
n very much better 2 8
n much better 7 15
n a little better 23 17
n no change 12 9
n worse 2 0
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure exercise Pelviva + exercise


0 weeks

N Analyzed 49 46
Median 3 3
Max 1 0
Min 4 5


12 weeks

N Analyzed 49 46
Median 2 1
Max 1 0
Min 4 4
Outcome: Leakage test: Other (placeholder)      Population: All Participants
Time Point Measure exercise Pelviva + exercise


0 weeks

N Analyzed 49 46
Median 2 2
Max 2 0
Min 6 6


12 weeks

N Analyzed 49 46
Median 2 2
Max 2 0
Min 4 6


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB not reported
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis Unclear RoB reasons for dropouts not given
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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 20% drop out
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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? Yes
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Quality Rating
No quality rating data was found.