Tele-rehabilitation for Women With Urinary Incontinence

NCT06161324 | Enrolling By Invitation

• 1 other identifier: Telerehab and incontinence
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

Tele-rehabilitation; urinary incontinence; stress incontinence; pelvic floor muscle exercise; adherence

Outcome Measures

Primary Outcomes (2)

• International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)

  Patient-centered questionnaire which contains questions that assess the frequency, severity, and impact of incontinence on patients. The ICIQ-UI SF (range 0-21) is given in four scoring categories: (a) slight symptoms (1-5), (b) moderate symptoms (6-12), (c) severe symptoms (13-18) and (d) very severe symptoms (19-21).

  At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)

• 1-hour Pad test

  Clinician-centered test by which, the pad is weighed before and after a set of specific-standardized exercises (walking, general exercises, etc.) during one hour. It is compared the difference in the amount of urine retained before and after the exercises in the pad, in order to de determined the urine leakage of the patient.Τhe 1-hour Pad test is given in three scoring categories: (a) mild incontinence (\<10 ml) , (b) moderate incontinence (11-50ml) and (c) severe incontinence (\>50 ml)

  At baseline (0 week) and at the end of the intervention (12 weeks)

Secondary Outcomes (6)

• PERFECT assessment scheme

  At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)

• Electromyographic (EMG) PFM's activity

  At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)

• Australian Pelvic Floor Questionnaire (APFQ)

  At baseline (0 week), and at the end of the intervention (12 weeks)

• Patient Global Impression of Improvement (PGI-I Scale)

  At the end of the intervention (12 weeks)

• Adherence questionnaire

  At the middle (6 weeks), and at the end of the intervention (12 weeks)

Other Outcomes (1)

• 3-day bladder diary

  At baseline (0 week) is provided the 3-day bladder diary and the patients will return it, after the 1st week

Study Arms (3)

Tele-rehabilitation group (TeleG)

EXPERIMENTAL

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.)

Other: PFM exercises program through the Mobile app in cooperation with the superficial sensor

Traditional treatment group (TrG)

ACTIVE COMPARATOR

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: Face-to face PFM exercises program in Healthcare environment

Control Group (CG)

OTHER

The participants of the control group (CG), will follow a pelvic floor muscle exercise program at home (via leaflet), without any supervision.

Other: PFM exercises program via home-leaflet(without suprevision)

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).

Tele-rehabilitation group (TeleG)

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

Traditional treatment group (TrG)

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)

Control Group (CG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Eligibility is based on biological gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greek women,
• years old,
• Diagnosis of SUI or mixed UI (via Urodynamic test).
• Writing and reading of the Greek language
• Usage of 'smartphones' and internet,
• Able to perform a voluntary muscle contraction of the PFM, during the clinical examination.

You may not qualify if:

• months after postpartum,
• Systemic diseases,
• Malignancy,
• Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
• Neurological dysfunction,
• Mental impairment

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras

Pátrai, Achaia, 26504, Greece

Location

Related Publications (1)

• Papanikolaou DT, Lampropoulou S, Giannitsas K, Skoura A, Fousekis K, Billis E. Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. Neurourol Urodyn. 2023 Apr;42(4):856-874. doi: 10.1002/nau.25150. Epub 2023 Feb 18.

  PMID: 36808744 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

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

Study Officials

• Evdokia Billis, PhD

  University of Patras, Department of Physiotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will remain hidden from the responsible physical therapist who will implement the treatment in the groups (he/she will be informed on the first day of the intervention for each patient). Due to the nature of the treatment, the intervention is not blinded between participants and clinicians. However, the analysis of the data will be 'blind' to all both parties, assessor and investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physiotherapy

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

GR (1)