Urinary Incontinence Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy
RECRUITING
Pátrai
Contact Information
Primary
Evdokia Billis, Professor
billis@upatras.gr
6973047170
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 60
Treatments
Experimental: BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group
In the BSATP Group, participants will use synchronous telerehabilitation methods such as communications platforms (e.g. Zoom etc.) and asynchronous methods like educational videos (created by the researchers to meet the needs of this study). Through these, they will follow a PFM exercise treatment program at a convenient location of their choice such as their home. No face-to face meetings will take place between participants and the therapist while supervision (regarding the execution, frequency of the PFM exercises etc.) will occur remotely.
Active_comparator: FtFS (Face-to face Sessions) Group
Participants will undertake their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist, drawing on therealistic treatment of UI, presently used in rehabilitation clinics etc.
Other: CG (Control Group)
In the CG, participants will follow their PFM exercise treatment program without any supervision or face-to-face sessions with their therapist.
Related Therapeutic Areas
Sponsors
Leads: University of Patras

This content was sourced from clinicaltrials.gov