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.

Launched by NANTES UNIVERSITY HOSPITAL · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device designed to help manage stress urinary incontinence (SUI) in women. SUI is a condition where people may leak urine during activities like laughing, sneezing, or exercising, and it can significantly affect their quality of life. The trial aims to see if using this device, along with two professional rehabilitation sessions, is as effective as traditional pelvic floor rehabilitation alone.

To participate, women aged 18 to 60 who have moderate to very severe SUI are eligible, especially if their quality of life score indicates they are struggling. Participants will need a smartphone to use the device and must be able to read and write in French. Throughout the study, they can expect to engage with the device for self-training exercises aimed at strengthening their pelvic floor. It's important to note that individuals with certain medical conditions, recent pregnancies, or specific anatomical issues may not qualify for the trial. If you're interested, you'll need to provide informed consent and have effective contraception during the study.

Gender

FEMALE

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