Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID06848517

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

Led by University of Patras · Updated on 2025-02-27

60

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different ways to deliver pelvic floor muscle (PFM) exercise programs to adult women in Greece who suffer from urinary incontinence, specifically stress or mixed types. The study compares a blended telerehabilitation program combining live video sessions and educational videos with traditional face-to-face therapy sessions and a control group receiving only written instructions. This study aims to explore how these approaches affect treatment effectiveness, patient adherence, supervision needs, and usability of telerehabilitation for urinary incontinence. Participants are assigned to one of three groups. The first group uses a blended program involving weekly live video calls with a therapist and watching educational videos to guide PFM exercises three times a week for 12 weeks. The second group attends weekly in-person therapy sessions with their therapist and performs additional exercises independently at home. The third group follows a home exercise program based on written instructions without therapist supervision. Exercise programs include endurance, speed, and "Knack maneuver" training, with positions changing every two weeks. Assessments occur at baseline, 6 weeks, 12 weeks, and follow-ups at 6 and 9 months. During the study, participants undergo evaluations of urinary incontinence symptoms, muscle function, and treatment adherence using questionnaires, physical assessments, and electromyographic measurements. Data on treatment usability and patient motivation are also collected. Safety and progress are monitored by therapists remotely or in person, depending on the group. The study lasts 12 weeks of treatment with long-term follow-up to assess lasting effects. Data are analyzed to compare outcomes between groups and understand the role of telerehabilitation in managing urinary incontinence.

CONDITIONS

Brief Title

Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Greek women
  • Aged 18 to 75 years old
  • Diagnosed with Stress Urinary Incontinence or Mixed Urinary Incontinence by Urodynamic examination
  • Able to read and write Greek
  • Able to use synchronous communication platforms (e.g., Zoom) and asynchronous educational videos on smartphones, tablets, or computers
  • Able to voluntarily contract pelvic floor muscles during initial clinical examination
Not Eligible

You will not qualify if you...

  • Less than 6 months postpartum
  • Presence of systemic diseases
  • Diagnosis of malignancy
  • Major gynecological surgery (such as total hysterectomy) in the last 10 years
  • Neurological dysfunction
  • Mental impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants follow a pelvic floor muscle (PFM) exercise treatment program lasting 12 weeks. Depending on the group, this includes weekly synchronous remote sessions with a therapist and educational videos (BSATP Group), weekly face-to-face sessions with a therapist (FtFS Group), or unsupervised home exercises guided by an educational leaflet (Control Group). The exercise program is individualized and involves three sessions per week with progressive adjustments every two weeks.

3 assessment visits at baseline, 6 weeks, and 12 weeks

Follow-up

Duration - Up to 9 months after baseline

Participants undergo follow-up assessments to monitor outcomes at 6 and 9 months after baseline.

2 follow-up visits at 6 and 9 months after baseline

Trial Site Locations

Total: 1 location

1

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

Pátrai, Rion, Achaia, Greece, GR26504

Actively Recruiting

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Research Team

E

Evdokia Billis, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence.

Dimitra Tania Papanikolaou, Sofia Lampropoulou, Konstantinos Giannitsas...

https://pubmed.ncbi.nlm.nih.gov/36808744