Clinical trial NCT06848517: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence,Stress
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
timeFrame: 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
measure: 1-hour Pad test
timeFrame: At baseline (0 week) and at the end of the intervention (12 weeks)
Secondary outcomes:
measure: PERFECT assessment scheme
timeFrame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: Electromyographic (EMG) PFM's activity
timeFrame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: Australian Pelvic Floor Questionnaire (APFQ)
timeFrame: 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
measure: Patient Global Impression of Improvement (PGI-I Scale)
timeFrame: At the end of the intervention (12 weeks)
measure: Adherence Questionnaire (AQ)
timeFrame: At the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: Adherence Exercise Diary (AED)
timeFrame: 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)
measure: Telehealth Usability Questionnaire (TUQ)
timeFrame: At the end of the intervention(12 weeks)
measure: "The Necessity of Creating Tele-rehabilitation Services for Pelvic Floor Dysfunctions (PFD)" through a Questionnaire
timeFrame: At baseline (0 weeks)
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy
state: Rion, Achaia
Study officials:
affiliation: University of Patras
name: Dimitra-Tania Papanikolaou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.