Clinical trial NCT06285292: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence, pelvic-floor muscles, pelvic-perineal rehabilitation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: FIZIMED Company
First posted: 2024-02-29
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)
* Patients with severe urinary retention
* Patient with vesico-ureteral reflux
* Patients with hypoactive bladder
* In case of peripheral denervation in the pelvic-perineal area, specialist advice is recommended
* Patients wearing a sacral neuromodulation device
* Patients in an exclusion period (determined by a previous or current study)
* Impossibility of giving the subject clear information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Patient under court protection
* Patient under guardianship or curatorship
* Pregnancy (positive pregnancy test)
* Breastfeeding (as the hormonal impregnation caused by breastfeeding has a negative impact on perineal tone)
* Use of Huawei and Oppo smartphones

Primary outcomes:
measure: Urinary symptoms using the ICIQ-UI SF questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life using the I-QoL questionnaire
timeFrame: 0 month, 1 month, 3 months, 6 months, 12 months
measure: Urinary symptoms using the ICIQ-UI SF questionnaire
timeFrame: 0 month, 1 month, 3 months, 12 months
measure: Cost-utility ratio using the EQ-5D questionnaire
timeFrame: 0 month, 1 month, 3 months, 6 months, 12 months
measure: Qualitative component
timeFrame: 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
References: