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.
| NCT ID | NCT06285292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2026-11-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2024-11-25 with a primary completion date of 2026-11-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06285292 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285292 currently recruiting?
Yes, NCT06285292 is actively recruiting participants. Contact the research team at thibault.thubert@chu-nantes.fr for enrollment information.
Where is the NCT06285292 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06285292 clinical trial?
NCT06285292 is sponsored by Nantes University Hospital. The trial plans to enroll 138 participants.