Tele-rehabilitation for Women With Urinary Incontinence

Sponsor
University of Patras
Study ID
NCT06161324
Status
Enrolling By Invitation

Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PFM exercises program through the Mobile app in cooperation with the superficial sensor — OTHER
    The mobile app will offer a personalized progressive protocol to the user based on his needs, via 12 levels of games(from the easiest to the hardest).The cooperating PFM superficial sensor will indicate the activity of the PFMs during the contraction.Νο face-to-face meetings will be incurred between participants and therapist. Participants will follow a program for 12 weeks(3 times weekly, 1-5 sessions daily, each session's duration approximately 20 minutes).Endurance training will involve slow velocity contraction and speed training will involve quick (i.e.1 sec duration) strong contractions."Knack maneuver" training will contain a pre-contraction before the increment of the intra-abdominal pressure during coughing. The exercise positions will change every 2 weeks (supine, side, prone, quadruped support, sitting and standing position).
  • Face-to face PFM exercises program in Healthcare environment — OTHER
    The therapy will include face-to-face meetings weekly, regarding the progress of the treatment and its smooth transition (intra-vaginally assessment when it needs, correction, encouragement, motivation, etc). Participants will follow a personalized progressive PFM exercise program for 12 weeks (3 times weekly, 1-5 sessions daily, each session's duration approximately 20 minutes).The endurance training will involve slow velocity contraction and the speed training will involve quick (i.e.1 sec duration) strong contractions. The "Knack maneuver" training will contain a pre-contraction before the increment of the intra-abdominal pressure during coughing. The exercise positions will change every 2 weeks.It will be followed the order of supine, side, prone, quadruped support, sitting and standing position
  • PFM exercises program via home-leaflet(without suprevision) — OTHER
    The participants of the CG will be advised to follow a personalized PFM exercise program at home based on their 1st meeting assessment. They will receive a comprehensive leaflet, with instructions and images about the PFM exercises at home. The PFM exercise program will last 12 weeks (3 times weekly, 1-5 sessions daily), without meetings, guidance and supervision by the physiotherapist. Similarly to the other two intervention groups, the program will contain endurance training (slow velocity contraction), speed training (quick contractions), "Knack maneuver" training (pre-contraction before coughing), and changing positions every 2 weeks (supine, side, prone, quadruped support, sitting and standing position)

Study Details

The prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%).Globally, the development of tele-rehabilitation programs through mobile application (mobile apps) has been a breakthrough for UI treatment. More specifically, the pelvic floor muscles (PFM) exercise programs through mobile apps, provide optimal health care services by offering to the patients a therapy program in the convenient environment of their choice (e.g their homes), with safety and less expense. Furthermore, it is given the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence. However, the majority of the existence mobile apps, work as simple verbal instructions and they do not being tailored in patients' individual needs, which is necessary for the successful implementation of the PFM exercise programs. Additionally, the PFM training is effective for UI treatment, when occurs intensively (daily) with supervision for at least 3 months by a physiotherapist. However, the adherence to a such intensive treatment program is very often compromised, because of many reasons (e.g lack of interest etc). Therefore the main purpose of the current study is, to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app (customized in patients needs), in cooperation with a PFM superficial sensor. The mobile app will offer an interactive environment and the opportunity of a simultaneous supervision by a physiotherapist during the treatment, which might provide sufficient motivation to the patient to adhere with the intensive PFM exercise program. A secondary objective of the study is, to investigate the degree of adherence to PFM exercises and the degree of supervision, which is needed in the tele-rehabilitation program. Both the mobile app and the PFM superficial sensor, will be created for the needs of the present study.

Key Dates

First listed
Dec 7, 2023
Start date
Nov 1, 2024
Status verified
Feb 2025
Primary completion
Nov 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tele-rehabilitation group (TeleG)
    The participants of the tele-rehabilitation group(TeleG), will remotely perform a pelvic floor muscle (PFM) exercises program at home in cooperation with a PFM superficial sensor. At the same time, the participants will be supervised remotely by the physiotherapist. Participants and therapist will communicate through the mobile app, either synchronously (i.e. through video calls) or asynchronously (i.e. through emails), regarding the execution of the PFM exercises (direction of the PFM contraction, frequency of the PFM exercise program etc.)
  • Active Comparator: Traditional treatment group (TrG)
    In the Traditional (classic) treatment group (TrG), participants will follow the usual care treatment of pelvic floor muscles, based on the "pragmatic" treatment of urinary incontinence, which is used today in rehabilitation clinics, centers etc.
  • Other: Control Group (CG)
    The participants of the control group (CG), will follow a pelvic floor muscle exercise program at home (via leaflet), without any supervision.

Primary Outcome Measure

International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) [ Time Frame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks) ]

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