Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT06285292
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06285292
Study Brief:
Protocol Section:
NCT06285292