Telehealth in the Rehabilitation of Urinary Incontinence in Older Women

January 9, 2024 updated by: Luis Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre

Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial

The goal of this randomized clinical trial is to compare the effectiveness of a pelvic floor rehabilitation program in a face-to-face versus remote in community-dwelling elderly women with urinary incontinence. The main question it aims to answer is: What is the difference in effectiveness of a pelvic floor rehabilitation program through face-to-face versus remote intervention? Participants will be divided into three groups: Synchronous Group: will receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist, Asynchronous Group: will receive guidance and perform a pelvic physiotherapy protocol after the evaluation, without the real-time monitoring by the physical therapist and face-to-face group: will receive guidelines and will perform a pelvic physiotherapy protocol oriented in person by the physical therapist. All groups will receive the same treatment for 12 weeks, which will include floor muscle training pelvic floor, urge suppression techniques, bladder training and behavioral therapy. Participants will be evaluated pre-treatment, at the end of the 6th week, and at the end of 12 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aging is associated with changes in body composition, including a decrease in skeletal muscle mass. As a result, approximately 30-40% of the elderly may experience urinary incontinence, considered one of the most important geriatric syndromes, associated with a negative impact on quality of life. In clinical practice, pelvic floor muscle training and behavioral therapy promote positive effects on pelvic floor rehabilitation when performed and guided through face-to-face consultations. Through Telehealth, the aspects that refer to the role of the physiotherapist, technologies used and format of the approach do not seem to be clarified. Virtual home care is an accepted reality because it improves access to health care and has a positive effect on outcomes. However, barriers to its use can affect the accessibility. According to the World Health Organization, the definition of telehealth is "the provision of health services, where distance is a critical factor, by all health professionals, using information and communication technologies to exchange valid information for diagnosis, treatment and prevention of disease and injury, research and evaluation, and for the continuing education of health professionals, all in the interest of promoting the health of individuals and their communities". The World Confederation for Physical Therapy defines digital practice, "a term used to describe health services, support, and information provided remotely through digital communication and devices." The main objective is "to facilitate the effective delivery of Physical Therapy services, improving access to care and information, and managing health resources". In Brazil, the Federal Council of Physiotherapy and Occupational Therapy published the resolution for the practice of telehealth in a pandemic period, teleconsultation, telemonitoring and teleconsultation. Our hypothesis is that the synchronous and asynchronous communication between the physiotherapist and the participants, with or without the help of caregivers, may enable adherence to the home rehabilitation process when compared to face-to-face treatment, minimizing the effects of urinary incontinence. This study proposes to contribute to knowledge in the field of Pelvic Physiotherapy, in particular, through telehealth to provide the service of rehabilitation for elderly women with pelvic floor disorders, using the advancement of technology as a facilitator of synchronous and asynchronous communication, to approach elderly urinary incontinence and still compare the two forms of rehabilitation through telehealth with the face-to-face treatment. It is widely known that urinary incontinence is a factor of social inhibition for causing embarrassment, in addition to producing disturbance in the sleep in the face of increased nocturnal voiding frequency, directly affecting the quality of life of the elderly. The proposed safe and guided by a physiotherapist through three rehabilitation programs, synchronous telerehabilitation (in real time), asynchronous telerehabilitation (without real-time contact) and face-to-face rehabilitation, can be used to provide interventions in order to optimize health-related quality of life.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 60 years old or more;
  • Urinary Incontinence for at least 12 months
  • Internet access.

Exclusion Criteria:

  • Pelvic cancer;
  • Sling surgery;
  • Urinary catheter;
  • Antimuscarinic medication;
  • Alzheimer;
  • Parkinson;
  • Multiple Sclerosis;
  • Uncontrolled diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synchronous Group
Will receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist.
Other: Pelvic physiotherapy
All groups will receive the same treatment for 12 weeks, which will include floor muscle training pelvic floor, urge suppression techniques, bladder training and behavioral therapy.
Experimental: Asynchronous Group
Will receive guidance and perform a pelvic physiotherapy protocol after the evaluation, without the real-time monitoring by the physical therapist
Other: Pelvic physiotherapy
All groups will receive the same treatment for 12 weeks, which will include floor muscle training pelvic floor, urge suppression techniques, bladder training and behavioral therapy.
Active Comparator: Face-to-face group
Will receive guidelines and will perform a pelvic physiotherapy protocol oriented in person by the physical therapist.
Other: Pelvic physiotherapy
All groups will receive the same treatment for 12 weeks, which will include floor muscle training pelvic floor, urge suppression techniques, bladder training and behavioral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Urinary Incontinence.
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Application of The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Type of Urinary Incontinence.
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Type of UI by self-report question: What kind of Has leakage occurred more frequently in the last 7 days?
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Frequency of Urinary Incontinence
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Self-reported frequency of leakage
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Frequency of Urinary Incontinence.
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Self-reported use of pads.
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Overactive bladder symptoms.
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Application of The International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ OAB)
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Quality of Life.
Time Frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Application of The International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol).
Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the study.
Time Frame: At the end of the 6th week and at the end of 12 weeks.

Self-reported adherence to the protocol:

Patients will report how many days they performed the guided exercises.
At the end of the 6th week and at the end of 12 weeks.
Patient's Satisfaction.
Time Frame: At the end of 12 weeks.
Application of The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS).
At the end of 12 weeks.
Patient's Satisfaction.
Time Frame: At the end of 12 weeks.
Application of The TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)
At the end of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Investigators

  • Study Director: Luís H. Telles da Rosa, Federal University of Health Sciences of Porto Alegre (UFCSPA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Estimated)

March 20, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFCSPAUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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