Urinary Stress IncontinencePhase 4NCT02029027
Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation
A Phase 4 study testing GYNEFFIK(R) in people with Urinary Stress Incontinence and Urinary Mixed Incontinence, run by Effik at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence, Urinary Mixed Incontinence
- What is being tested?
- GYNEFFIK(R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- GYNEFFIK(R), Usual Care
- Keywords
- Urinary Stress Incontinence, Urinary Mixed Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYNEFFIK(R)Device
Vaginal electro-stimulation medical device
Usual CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| GYNEFFIK(R) | Experimental | 30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods) Receives: Device: GYNEFFIK(R) |
| 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 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 Months (or last measurement if premature ending)
Secondary outcomes (6)
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%
Measured: 6 Months (or last measurement if premature ending)
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%
Measured: 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).
Measured: 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
Measured: 6 Months (or last measurement if premature ending)
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
Measured: 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
Measured: 6 Months (or last visit if premature ending)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Bernardini, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029027
- Sponsor's protocol ID
- 2012-A00235-38
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02029027
- Acronym / sponsor ID
- 2012-A00235-38
- Keywords
- Urinary Stress Incontinence, Urinary Mixed Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- EffikIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GYNEFFIK(R) | Experimental | Device: GYNEFFIK(R)30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods) |
| Usual Care | Other | Other: Usual CareAny 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GYNEFFIK(R)Vaginal electro-stimulation medical device | Device | GYNEFFIK(R) |
| Usual CareAny 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 |
Primary outcome
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)
6 secondary outcomes
ICIQ Score
Time frame: 6 Months (or last measurement if premature ending)
DITROVIE Score
Time frame: 6 Months (or least measurement if premature ending)
ICG score
Time frame: 6 Months (or last measurement if premature ending)
SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)
Time frame: 6 Months (or last measurement if premature ending)
HAD (Hospital Anxiety and Depression) scale
Time frame: 6 months (or last measurement if premature ending)
Bladder diary
Time frame: 6 Months (or last visit if premature ending)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
Related trials for Urinary Stress Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bernardini, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GYNEFFIK(R) in people with Urinary Stress Incontinence and Urinary Mixed Incontinence, run by Effik at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Worsening of ICIQ + Ditrovie Scales' Scores (time frame: 6 Months (or last measurement if premature ending)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.