Phase
Condition
Urinary Incontinence
Enuresis
Treatment
Electrical stimulation and biofeedback group
Electrical stimulation and biofeedback with the medical device Phenix Liberty
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient who is incontinent (involuntary loss of urine) and/or has an overactivebladder (pollakiuria defined as more than one nocturnal urination and more than sixdaytime urination or leakage per day); Incontinent patient requiring functionalrehabilitation of pelvic static disorders by electrostimulation and biofeedback;
Adult patient (between 18 / 75 years old);
Patient with at least one of the following symptoms related to a pelvic staticdisorder: pain, hypertonia, muscle weakness, decreased or loss of motor control,trophic abnormality;
Patient who can make herself available to participate in the sessions regularly andwho believes that she will be able to complete the tenth treatment session no laterthan 8 weeks after V0;
Patient who has signed the consent form to participate in the study;
Patient physically and mentally willing and able, in the judgment of theinvestigator at the time of recruitment, to perform the procedures under study;
Patient with social protection.
Exclusion
Exclusion Criteria:
Patient with peripheral or central neurological involvement (perianal or perivulvarsensitivity disorder);
Patient with BMI ≥30 kg/m²
Patient who has had more than 3 deliveries;
Patient with stroke, Alzheimer's, multiple sclerosis, spinal cord involvement,narrow lumbar canal, cauda equina syndrome, or cognitive and/or behavioralimpairment that may, in the practitioner's judgment, interact with theself-questionnaire or biofeedback assessment;
Pregnant woman at the inclusion visit;
Patient with an implanted pacemaker or spinal cord trainer;
Patient with hypersensitivity to electrostimulation;
Patient with such vaginal atrophy that an endovaginal probe cannot be used
Patient with chronic or recurrent vaginal or urinary tract infection on long-termtreatment;
Patient with vaginal pathology (undiagnosed bleeding, cancer in the area to betreated);
Patient who has renounced her liberty by administrative or judicial sentence, or whois under guardianship or limited judicial protection;
Patient participating in an interventional clinical trial or testing/having testedan investigational drug and/or medical device within 30 days prior to inclusion inthe study in relation to the relevant pathology;
Patient who cannot read or write French;
Patient refusing to participate in the study.
Study Design
Study Description
Connect with a study center
Pôle santé de la Nartassière
Mouans-Sartoux, 06370
FranceSite Not Available
Espace Human Physion
Nîmes, 30000
FranceSite Not Available
Human Physio
Nîmes, 30000
FranceSite Not Available


Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.