Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Nantes University Hospital
- Enrollment
- 138
- Primary Endpoint
- Urinary symptoms using the ICIQ-UI SF questionnaire
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.
Detailed Description
Two groups will be studied: * the control group will undergo 15 sessions of pelvic-perineal rehabilitation, corresponding to the gold standard. * the intervention group will use the medical device 3 times a week for 15 minutes over a 3-month period, in addition to 2 rehabilitation sessions. The participant will then be able to modify her program according to her symptoms. Recruitment will be carried out with the help of healthcare professionals. The investigators involved in the study will be physiotherapists specializing in pelvic-perineal rehabilitation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21))
- •Patient aged between 18 and 60
- •Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100)
- •Not to have given birth in the last 6 months (to avoid post-partum physiological recovery)
- •Signed informed consent
- •Effective contraception throughout the study (declarative)
- •Patient must have a smartphone running at least Android 7 and iOS 12
- •Patient must be able to read and write French
Exclusion Criteria
- •Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5))
- •Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100)
- •Patient undergoing other pelvic-perineal rehabilitation during the study period
- •Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter
- •Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever)
- •Contraindications to the use of the medical device
- •Anatomy making catheter placement difficult or impossible; in the case of prolapse, specialist advice is recommended.
- •Hemorrhage
- •Patients with genitourinary cancer (within the last 5 years)
- •Patients with extra-urethral "incontinence" (fistula, ectopic ureter)
Outcomes
Primary Outcomes
Urinary symptoms using the ICIQ-UI SF questionnaire
Time Frame: 6 months
The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.
Secondary Outcomes
- Cost-utility ratio using the EQ-5D questionnaire(0 month, 1 month, 3 months, 6 months, 12 months)
- Quality of life using the I-QoL questionnaire(0 month, 1 month, 3 months, 6 months, 12 months)
- Urinary symptoms using the ICIQ-UI SF questionnaire(0 month, 1 month, 3 months, 12 months)
- Qualitative component(1 month, 3 months, 6 months, 12 months)