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Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation

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ClinicalTrials.gov Identifier: NCT02029027
Recruitment Status : Unknown
Verified January 2014 by Effik.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Effik

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Urinary Mixed Incontinence Device: GYNEFFIK(R) Other: Usual Care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation de l'intérêt de l'électrostimulation Intra-vaginale à Domicile Par Rapport à Une Prise en Charge Habituelle Dans la Prise en Charge de Patientes Incontinentes Ayant bénéficié d'Une rééducation périnéale
Study Start Date : August 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GYNEFFIK(R)
30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)
 Device: GYNEFFIK(R)
Vaginal electro-stimulation medical device
Usual Care
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
 Other: Usual Care
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


Outcome Measures
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Primary Outcome Measures :
  1. Non-Worsening of ICIQ + Ditrovie Scales' Scores [ Time Frame: 6 Months (or last measurement if premature ending) ]

    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)



Secondary Outcome Measures :
  1. ICIQ Score [ Time Frame: 6 Months (or last measurement if premature ending) ]

    Quantitative analyses:

    • difference = ICIQ_M6 - ICIQ_D0
    • variation (%)= 100 x (ICIQ_M6 - ICIQ_D0)/ICIQ_D0

    Qualitative analysis

    * % of patients with a variation % <-10%, between -10% and +10%, >10%


  2. DITROVIE Score [ Time Frame: 6 Months (or least measurement if premature ending) ]

    Quantitative analyses:

    • difference = DITROVIE_M6 - DITROVIE_D0
    • variation (%)= 100 x (DITROVIE_M6 - DITROVIE_D0)/(DITROVIE_D0 - 10)

    Qualitative analysis

    * % of patients with a variation % <-10%, between -10% and +10%, >10%


  3. ICG score [ Time Frame: 6 Months (or last measurement if premature ending) ]
    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).

  4. SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey) [ Time Frame: 6 Months (or last measurement if premature ending) ]

    Difference = M6 -D0

    Variation % = 100 x (M6 - D0)/D0


  5. HAD (Hospital Anxiety and Depression) scale [ Time Frame: 6 months (or last measurement if premature ending) ]

    Qualitative analysis:

    • improvement from sub-score > 10 to sub-score < 10
    • no change
    • worsening from sub-score < 10 to sub-score > 10

  6. Bladder diary [ Time Frame: 6 Months (or last visit if premature ending) ]

    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



Other Outcome Measures:
  1. Adverse Events [ Time Frame: 6 Months ]
  2. Compliance [ Time Frame: 6 Months ]
    The lasts electro-stimulation sessions are recorded by the medical device.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • out-patient over 18 years old, having understood and signed the Informed Consent Form
  • seen for urinary stress incontinence or urinary mixed incontinence (with a major stress incontinence part) troubles
  • spontaneously asking for help
  • who can be followed for a long time

Exclusion Criteria:

  • Urinary Incontinence (UI) found out during medical interviewing without spontaneous complaint
  • Urinary troubles due to neurological pathology (stroke, multiple sclerosis, ...)
  • UI due to congenital malformation
  • UI having led to surgery
  • UI treated in the last 6 months
  • UI within 24 weeks of Past Partum
  • Pelvic surgery within 12 months
  • On-going inflammatory or infectious neoplastic disease
  • Perineal hypoesthesia
  • Local conditions prohibiting the use of an intra-vaginal device (vaginal atrophia, continuous metrorrhagia, vaginal prolapse > 2°, ...)
  • Pacemaker use
  • Women of child bearing potential without effective method of contraception or planning to get pregnant in the next 12 months
  • Intravaginal contraception
  • Mental impairment or inability to understand or follow study instructions
  • Patient who may not come back to the study visits
  • Patient already enrolled for another study or having been enrolled in another clinical study in the past 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029027


Locations
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France
Marc Bernardini
Marseille, France, 13008
Sponsors and Collaborators
Effik
Investigators
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Principal Investigator: Marc Bernardini, MD
More Information
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Responsible Party: Effik
ClinicalTrials.gov Identifier: NCT02029027    
Other Study ID Numbers: 2012-A00235-38
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Effik:
Urinary Stress Incontinence
Urinary Mixed Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations