Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence

NCT06848517 | Recruiting

• 1 other identifier: Incontinence&Telerehab Methods
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (2)

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

  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).

  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

  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)

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

Secondary Outcomes (8)

• 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)

Study Arms (3)

BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group

EXPERIMENTAL

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.

Other: BSATP Group

FtFS (Face-to face Sessions) Group

ACTIVE COMPARATOR

Participants will undertake their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist, drawing on the"realistic" treatment of UI, presently used in rehabilitation clinics etc.

Other: FtFS Group

CG (Control Group)

OTHER

In the CG, participants will follow their PFM exercise treatment program without any supervision or face-to-face sessions with their therapist.

Other: Control Group (CG)

Interventions

BSATP Group OTHER

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 training (quick contractions) and "Knack maneuver" training (pre-contraction before the increment of the intra-abdominal pressure).The PFM exercise program will be based on three assessments conducted by the therapist throughout the study (baseline, 6 weeks and 12 weeks). As a result, the PFM exercise program will be individualized to meet their needs and progressively increases in difficulty, with the exercise position being modified every two weeks (e.g. supine, side, prone ect)

Also known as: Blended Synchronous and Asynchronous Telerehabilitation Programs

BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group

FtFS Group OTHER

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. The participants in the FtFS group will follow the same PFM exercise treatment program as the BSATP group, which will be an individualized program where the position will change every two weeks and include endurance training, speed training and 'Knack maneuver' training.

Also known as: Face-to face Sessions

FtFS (Face-to face Sessions) Group

Control Group (CG) OTHER

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 treatment period. Similarly to the other two intervention groups, the provided PFM exercise treatment program will be individualized, will include endurance training, speed training, and 'Knack maneuver' training, and the participants will be encouraged to change their exercise position on their own every two weeks.

Also known as: PFM exercises without supervision

CG (Control Group)

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 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.

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)

University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy

Pátrai, Rion, Achaia, GR26504, Greece

RECRUITING

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, Stress

Interventions

Control Groups; Organization and Administration

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Services Administration

Study Officials

• Dimitra-Tania Papanikolaou

  University of Patras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evdokia Billis, Professor

CONTACT

6973047170; billis@upatras.gr

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 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD(c)

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 27, 2025
• Study Start: February 15, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

GR (1)