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.

NCT06285292 | Not Yet Recruiting

• 1 other identifier: RC24_0097
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urinary symptoms using the ICIQ-UI SF questionnaire

  The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.

  6 months

Secondary Outcomes (4)

• Quality of life using the I-QoL questionnaire

  0 month, 1 month, 3 months, 6 months, 12 months

• Urinary symptoms using the ICIQ-UI SF questionnaire

  0 month, 1 month, 3 months, 12 months

• Cost-utility ratio using the EQ-5D questionnaire

  0 month, 1 month, 3 months, 6 months, 12 months

• Qualitative component

  1 month, 3 months, 6 months, 12 months

Study Arms (2)

EMY (connected biofeedback medical device)

EXPERIMENTAL

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.

Device: EMY

standard

NO INTERVENTION

15 sessions of pelvic floor rehabilitation (gold standard)

Interventions

EMY 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

Also known as: pelvic-perineal probe

EMY (connected biofeedback medical device)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• FIZIMED Company: collaborator

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thibault THUBERT, PHD

CONTACT

02.53.48.24.43; thibault.thubert@chu-nantes.fr

Selma EL ANDALOUSSI, manager

CONTACT

02.53.48.28.52; selma.elandaloussi@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02