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Study Title and Description

Multicentric prospective randomized and controlled study assessing effectiveness of intravaginal electrostimulation at home compared to usual care in female patients with urinary incontinence and prior perineal reeducation.



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 Multicentric prospective randomized and controlled study assessing effectiveness of intravaginal electrostimulation at home compared to usual care in female patients with urinary incontinence and prior perineal reeducation.
Author Lopès P., Rimbault F., Scheffler M., André C., Cappelletti MC., Marès P.
Country Service de gynécologie-obstétrique, hôpital mère-enfant, CHU de Nantes, 7, Quai-Moncousu, 44000 Nantes, France. Electronic address: patrice.lopes@chu-nantes.fr.
Year 2014
Numbers Pubmed ID: 25444700

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Home perineal electrostimulation [HPES] electrostimulation sessions (GYNEFFIK1 or home perineal electrostimulation [HPES] arm)
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2 Usual care Usual care (UC) only, without electrostimulation
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries France
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Funding source Not reported
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Inclusion criteria Women with stress or mixed UI (composed predominantly of stress UI) who responded favorably to the initial 10- 15 session rehabilitation. The response was defined at the same time by a clinical improvement based on the investigator's criteria, and by a ICIQ score <= 12.
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Exclusion criteria Patients who had given birth less than 6 months before, who had a pelvic surgery less than a year before, presented a disorder related to neurological disease or cognitional malformation, a urinary incontinence treated with surgically, or treated with medication in the last 6 months, a perineal hypoesthesia or local conditions that interfered with the use of a inter-vaginal probe.
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UI type
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68
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32
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mixed with predominately stress UI
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Age 51.24
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mean
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13.7
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24, 84
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Men included 0
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Special populations 163
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100
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Race 163
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100
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Notes
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Did participants fail previous treatment? ... Yes ... 100% physiotherapy. Didn't fail. This studies was just to maintain the improvement.
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Study years
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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 Home perineal electrostimulation [HPES] Usual care Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 77 86 163
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76 85 161
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12 4 16
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: PE: Other (placeholder)      Population: All Participants
Time Point Measure Home perineal electrostimulation [HPES] Usual care


6 months

N Analyzed 76 85
n improved 63 58
n no change 13 13
n worse 0 14




N Analyzed
Mean
SD
SE
Outcome: Quality of life      Population: All Participants
Time Point Measure Home perineal electrostimulation [HPES] Usual care


0 months

N Analyzed
Mean
SD
SE


6 months

N Analyzed
Mean
SD
SE
Outcome: Quality of life      Population: All Participants
Time Point Measure Home perineal electrostimulation [HPES] Usual care


0 months

N Analyzed
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SD
SE


6 months

N Analyzed
Mean
SD
SE
Outcome: Quality of life      Population: All Participants
Time Point Measure Home perineal electrostimulation [HPES] Usual care


0 months

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6 months

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Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB randomization was done in clusters
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RCT:.....Allocation concealment Unclear RoB
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RCT:.....Blinding of PATIENTS Low RoB
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RCT.....Intention-to-treat-analysis Low RoB 2/163 drop-outs
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Unclear RoB
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) High RoB IMC and ICIQ score significantly differed between groups at baseline.
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ALL.....Compliance with interventions Unclear 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
Guideline Used Overall Rating