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

Primary Purpose

Urinary Stress Incontinence, Urinary Mixed Incontinence

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
GYNEFFIK(R)
Usual Care
Sponsored by
Effik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Urinary Stress Incontinence, Urinary Mixed Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Marc Bernardini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

GYNEFFIK(R)

Usual Care

Arm Description

30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

ICIQ Score
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%
DITROVIE Score
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%
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).
SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)
Difference = M6 -D0 Variation % = 100 x (M6 - D0)/D0
HAD (Hospital Anxiety and Depression) scale
Qualitative analysis: improvement from sub-score > 10 to sub-score < 10 no change worsening from sub-score < 10 to sub-score > 10
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

Full Information

First Posted
January 6, 2014
Last Updated
January 6, 2014
Sponsor
Effik
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1. Study Identification

Unique Protocol Identification Number
NCT02029027
Brief Title
Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Effik

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence, Urinary Mixed Incontinence
Keywords
Urinary Stress Incontinence, Urinary Mixed Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GYNEFFIK(R)
Arm Type
Experimental
Arm Description
30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)
Arm Title
Usual Care
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
GYNEFFIK(R)
Intervention Description
Vaginal electro-stimulation medical device
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Non-Worsening of ICIQ + Ditrovie Scales' Scores
Description
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)
Time Frame
6 Months (or last measurement if premature ending)
Secondary Outcome Measure Information:
Title
ICIQ Score
Description
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%
Time Frame
6 Months (or last measurement if premature ending)
Title
DITROVIE Score
Description
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%
Time Frame
6 Months (or least measurement if premature ending)
Title
ICG score
Description
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).
Time Frame
6 Months (or last measurement if premature ending)
Title
SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)
Description
Difference = M6 -D0 Variation % = 100 x (M6 - D0)/D0
Time Frame
6 Months (or last measurement if premature ending)
Title
HAD (Hospital Anxiety and Depression) scale
Description
Qualitative analysis: improvement from sub-score > 10 to sub-score < 10 no change worsening from sub-score < 10 to sub-score > 10
Time Frame
6 months (or last measurement if premature ending)
Title
Bladder diary
Description
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
Time Frame
6 Months (or last visit if premature ending)
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
6 Months
Title
Compliance
Description
The lasts electro-stimulation sessions are recorded by the medical device.
Time Frame
6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bernardini, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marc Bernardini
City
Marseille
ZIP/Postal Code
13008
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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