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. (PRIME)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: EMY

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thibault THUBERT, PHD; Phone Number: 02.53.48.24.43; Email: thibault.thubert@chu-nantes.fr
• Study Contact Backup: Name: Selma EL ANDALOUSSI, manager; Phone Number: 02.53.48.28.52; Email: selma.elandaloussi@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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; Other Names: pelvic-perineal probe
No Intervention: standard; 15 sessions of pelvic floor rehabilitation (gold standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life using the I-QoL questionnaire	changes in quality of life will be studied using the validated I - QoL questionnaire	0 month, 1 month, 3 months, 6 months, 12 months
Urinary symptoms using the ICIQ-UI SF questionnaire	changes in urinary symptoms will be studied using the validated ICIQ-UI SF questionnaire	0 month, 1 month, 3 months, 12 months
Cost-utility ratio using the EQ-5D questionnaire	The cost/utility ratio will be studied using the cost/QALY ratio. The costs will relate to the consumption of reimbursed or non-reimbursed care (medical and paramedical consultations, hospitalization, drug treatment, absorbent pads, pessaries, etc.). QALYs will be estimated on the basis of responses to the validated EQ-5D 5L questionnaire.	0 month, 1 month, 3 months, 6 months, 12 months
Qualitative component	the qualitative component will consist of questionnaires evaluating : consumption of care at M0, M1, M3, M6 and M12 ;; ease of access to care at M1 ;; treatment satisfaction with the standardized PGI-I questionnaire and the question "do you recommend your treatment to a friend ?" at M3;; treatment adherence using a diary and a Likert scale between M0 and M3	1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: FIZIMED Company

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: urinary incontinence, pelvic-floor muscles, pelvic-perineal rehabilitation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: RC24_0097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No