The Effectiveness of a Blended Synchronous and Asynchronous Telerehabilitation Program for Greek Adult Women With Urinary Incontinence. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Patras
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
Study Overview
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.
- 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.
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
The randomization list will be kept confidential from the therapist who will administer the treatment groups. The therapist will be made aware of each patient's assignment on the first day of the intervention. The participants will remain unaware of the group to which they belong until the moment the intervention begins. Given the nature of the treatment, the intervention is not blinded between participants and therapists. However, the data analysis will be carried out by a 'blind' assessor.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
The ICIQ-UI-SF is a patient-centered questionnaire. It includes questions that evaluate the frequency, severity, and impact of incontinence. The ICIQ-UI SF (range 0-21) is assessed using 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).
1-hour Pad test
Time Frame: At baseline (0 week) and at the end of the intervention (12 weeks)
The 1-hour Pad test is a clinician-administered test. The pad is weighed, the participant wear the pad and executes a set of standardized exercises (squats, running on the spot etc.). After one hour the pad re-weighed and estimated the difference in the amount of urine leakage before and after the exercises in the pad.Τhe 1-hour Pad test is assessed using three scoring categories:(a) mild incontinence (\<10 ml), (b) moderate incontinence (11-50ml) and (c) severe incontinence (\>50 ml)
Secondary Outcomes
- 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 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)(At the end of the intervention (12 weeks))
- Adherence Questionnaire (AQ)(At the middle (6 weeks), and at the end of the intervention (12 weeks))
- Adherence Exercise Diary (AED)(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)(At the end of the intervention(12 weeks))
- "The Necessity of Creating Tele-rehabilitation Services for Pelvic Floor Dysfunctions (PFD)" through a Questionnaire(At baseline (0 weeks))
Investigators
Papanikolaou Dimitra-Tania
PhD(c)
University of Patras