Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence

Official title

The Effectiveness of a Blended Synchronous and Asynchronous Telerehabilitation Program for Greek Adult Women With Urinary Incontinence. A Randomized Controlled Trial

Overview

In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months' duration. Unfortunately, patients' adherence to PFM exercises programs is often compromised for various reasons (lack of patient interest, inability to exercise daily etc.). Therefore, the development of synchronous and asynchronous telerehabilitation programs has revolutionized UI treatment, because they offer an interactive environment which might increase patient motivation and improve patient's adherence to this demanding PFM exercise regime. Synchronous Telerehabilitation Programs (STP) have developed via communication platforms that allow users to connect with video, audio, phone, and chat applications (e.g. Zoom), where users can interact in real time with their therapist and follow their treatment through the PFM exercise program. Furthermore, Asynchronous Telerehabilitation Programs (ATP) have emerged via mobile applications, educational videos etc., where users can follow their treatment using the PFM exercise program at a more convenient time that fits into their personal schedule. Although some studies have examined either STP or ATP with or without face-to-face sessions, no study has investigated a blended approach of STP and ATP for the management of UI. Given the above, the primary aim of this study is to evaluate the effectiveness of a blended STP and ATP, in comparison to face-to-face therapy sessions. A secondary objective is to investigate the level of patients' adherence, and the amount of supervision required, in a blended STP and ATP. Furthermore, the necessity of telerehabilitation programs (whether provided in a synchronous or asynchronous manner) in the field of pelvic floor dysfunctions specifically in UI, will be explored. Finally, the study will assess the usability of a telerehabilitation program (whether provided in a synchronous or asynchronous manner) in women with UI.

Detailed description

The study is designed to be conducted with three groups.

1. st. In the Blended STP and ATP (BSATP) group, participants will use communication platforms and educational videos to follow their PFM exercise treatment. No face-to face meetings will take place between participants and the therapist while supervision will occur remotely. 2. nd.In the Face-to-face Sessions (FtFS) group, participants will follow their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist. 3. rd. In the Control Group (CG), participants will follow their PFM exercise treatment without any supervision or face-to-face sessions with their therapist.

Three assessments sessions will take place at baseline (0 week), half-way at 6 weeks and at the end of the treatment (after 12 weeks). A follow-up assessment will be conducted at 6 and 9 months after the baseline.

Participants will be selected voluntarily through the University Urology clinic, social networks (e.g. facebook), etc. This study has been approved by the Research Ethics Committee (R.E.C.). All participants' data will be archived anonymously in a secure cloud platform accessible only to members of the research team.

To guarantee complete allocation concealment of the groups, a randomization process will be employed by a 'blind' researcher with no knowledge of the assessment or treatment procedures. The distribution of the participants to the three groups will be undertaken through a pre-defined computer-generated list, in blocks of six people. Each participant will receive a randomly assigned number from the list (through sealed envelopes), after which participants will be randomly assigned to one of the three groups using sealed envelopes.To accomplish a homogeneous sample distribution between the groups, each block will encompass three envelopes for every group. Given the nature of the treatment, the intervention is not blinded between participants and therapists. However, the data analysis will be carried through a 'blind' assessor.

An intention-to-treat analysis will performed, based on the initial allocation of participants into groups. The data will be gathered in excel tables and through Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows. An analysis within the groups before and after the intervention, will be conducted using repeated measurements ANOVA. An analysis between the groups after the intervention will be carried out by the Student t-test (independent measurements). Furthermore, the effect size with 95% confidence intervals will be measured for each outcome measure with continuous variables. Results will be deemed statistically significant if p\<.05. Finally, the results will be provided by means (M) values and their standard deviations (SD).

Interventions

• Other BSATP Group
  Participants and the therapist will communicate once weekly synchronously (e.g. through video calls with a 30 minute duration), regarding the proper execution of the PFM exercises, providing motivation etc. Additionally, participants will be advised to watch the educational videos (10 mins duration) asynchronously twice a week. In total, participants will follow a BSATP three times a week (for 12 weeks). The PFM exercise program will include endurance training (slow velocity contractions), speed
• Other FtFS Group
  Participants will attend one weekly face-to-face session with their therapist, to discuss the progress of their treatment and ensure its seamless continuation (intra-vaginal assessment, adjustments, motivation etc.). Each session will last approximately 30 minutes. Participants will also be advised to perform the PFM program twice a week on their own e.g. at home. In total, participants will follow a PFM program three times a week (for 12 weeks), once with their therapist and twice independently
• Other Control Group (CG)
  The participants will be advised to follow a PFM exercise treatment program at home, based on an educational home leaflet (with instructions and images about PFM exercises) that they received during their first assessment session (baseline). The participants of this group will follow a PFM exercise therapy program (through the leaflet) which will last 12 weeks and they will be advised to attend it three times a week. No face-to-face meetings or supervision will occur by the therapist during the

Primary outcome measures

• International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) [Time frame: At baseline (0 weeks), in the middle (6 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period]
• 1-hour Pad test [Time frame: At baseline (0 week) and at the end of the intervention (12 weeks)]

Secondary outcome measures (8)

• PERFECT assessment scheme [Time frame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)]
• Electromyographic (EMG) PFM's activity [Time frame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)]
• Australian Pelvic Floor Questionnaire (APFQ) [Time frame: At baseline (0 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period]
• Patient Global Impression of Improvement (PGI-I Scale) [Time frame: At the end of the intervention (12 weeks)]
• Adherence Questionnaire (AQ) [Time frame: At the middle (6 weeks), and at the end of the intervention (12 weeks)]
• Adherence Exercise Diary (AED) [Time frame: At baseline (0 week) the PFM AED is supplied to the participants, who will then re-submit it at the end of the intervention(12 weeks)]
• Telehealth Usability Questionnaire (TUQ) [Time frame: At the end of the intervention(12 weeks)]
• "The Necessity of Creating Tele-rehabilitation Services for Pelvic Floor Dysfunctions (PFD)" through a Questionnaire [Time frame: At baseline (0 weeks)]

Eligibility criteria

Inclusion criteria

• Greek women,
• 18-75 years old,
• Diagnosis of Stress Urinary Incontinence (SUI) or Mixed UI (via Urodynamic examination).
• Writing and reading of the Greek language
• Having ease in using synchronous communication platforms (e.g., Zoom) and asynchronous educational videos via smart phones, tablets, computers etc
• Able to voluntarily contract the PFM, during the initial clinical examination.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Greece · 1 center

• University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy — Pátrai

Publications

• 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

Identifiers

NCT: NCT06848517 · Incontinence&Telerehab Methods

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗