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

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-06-30

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence, pelvic-floor muscles, pelvic-perineal rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMY (connected biofeedback medical device)

2 rehabilitation between M0 and M2 and pelvic-perineal exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months.

Group Type: EXPERIMENTAL

EMY

Intervention Type: DEVICE

Patients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then, for a further 3 months, their program can be modified for free, on-demand use (e.g. 2 x 10 minutes per week). After the main criterion at M6, they will be free to modify their rehabilitation program in the application according to their symptoms, and follow their program until the end of the study

standard

15 sessions of pelvic floor rehabilitation (gold standard)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMY

Patients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then, for a further 3 months, their program can be modified for free, on-demand use (e.g. 2 x 10 minutes per week). After the main criterion at M6, they will be free to modify their rehabilitation program in the application according to their symptoms, and follow their program until the end of the study

Intervention Type: DEVICE

Other Intervention Names

pelvic-perineal probe

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

FIZIMED Company

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Thibault THUBERT, PHD

Role: CONTACT

Phone: 02.53.48.24.43

Email: thibault.thubert@chu-nantes.fr

Selma EL ANDALOUSSI, manager

Role: CONTACT

Phone: 02.53.48.28.52

Email: selma.elandaloussi@chu-nantes.fr

Other Identifiers

RC24_0097

Identifier Type: -

Identifier Source: org_study_id