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The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GYNEFFIK(R) | Experimental | 30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods) |
|
| Usual Care | Other | Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GYNEFFIK(R) | Device | Vaginal electro-stimulation medical device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Worsening of ICIQ + Ditrovie Scales' Scores | The primary outcome is defined as the non worsening of the ICIQ (International Consultation on Incontinence modular Questionnaire) scale's score AND the DITROVIE scale's score (a specific scale to evaluate the perturbation of the quality of life during urinary troubles). The scores will be considered as maintained if they didn't increase more than 10% with the following calculation: ICIQ variation (%) = 100 x (ICIQ_M6 - ICIQ_D0)/ICIQ_D0 DITROVIE variation (%) = 100 x (DITROVIE_M6 - DITROVIE_D0)/(DITROVIE_D0 -10) | 6 Months (or last measurement if premature ending) |
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ Score | Quantitative analyses:
Qualitative analysis * % of patients with a variation % <-10%, between -10% and +10%, >10% | 6 Months (or last measurement if premature ending) |
| DITROVIE Score |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 6 Months | |
| Compliance | The lasts electro-stimulation sessions are recorded by the medical device. | 6 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Bernardini, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marc Bernardini | Marseille | 13008 | France |
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| Usual Care |
| Other |
Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation |
|
Quantitative analyses:
Qualitative analysis * % of patients with a variation % <-10%, between -10% and +10%, >10% |
| 6 Months (or least measurement if premature ending) |
| ICG score | The ICG (clinical global impression) score is the subjective impression of the patient regarding the evolution of her own clinical condition. It will be determined between inclusion and M6 (or the last visit). | 6 Months (or last measurement if premature ending) |
| SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey) | Difference = M6 -D0 Variation % = 100 x (M6 - D0)/D0 | 6 Months (or last measurement if premature ending) |
| HAD (Hospital Anxiety and Depression) scale | Qualitative analysis:
| 6 months (or last measurement if premature ending) |
| Bladder diary | A bladder diary will be filled by the patient for 3 days before the inclusion visit and then for 3 days before the final visit. The following items will be compared between D0 and M6: normal urinary episodes, incontinence episodes and drinks, in number and volume. Difference = M6 - D0 Variation % = 100 x (M6-D0)/D0 | 6 Months (or last visit if premature ending) |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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