Telehealth in the Rehabilitation of Urinary Incontinence in Older Women

• ClinicalTrials.gov Identifier: NCT06200922
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2024
• Last Update Posted: January 11, 2024
• Sponsor: Federal University of Health Science of Porto Alegre
• Information provided by (Responsible Party): Luis Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence in Old Age	Other: Pelvic physiotherapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: The evaluations will be performed by a different researcher.
• Primary Purpose: Treatment
• Official Title: Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial
• Actual Study Start Date: April 20, 2022
• Actual Primary Completion Date: December 20, 2023
• Estimated Study Completion Date: March 20, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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?
3. 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
4. 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.
5. 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)
6. 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).

Secondary Outcome Measures :

1. 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.

2. 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).
3. Patient's Satisfaction. [ Time Frame: At the end of 12 weeks. ]
   Application of The TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170

Sponsors and Collaborators

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)

More Information

Additional Information:

Federal Council of Physiotherapy and Occupational Therapy resolution about the practice of telehealth 

Publications:

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BØ, K. et al. Evidence-Based Physical Therapy for the Pelvic Floor: Bridging Science and Clinical Practice. 2. ed. London: Churchill Livingstone, 2015. E-book.

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• Responsible Party: Luis Henrique Telles da Rosa, Clinical Professor, Federal University of Health Science of Porto Alegre
• ClinicalTrials.gov Identifier: NCT06200922
• Other Study ID Numbers: UFCSPAUI
• First Posted: January 11, 2024
• Last Update Posted: January 11, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre:

Urinary Incontinence; Old Age; Pelvic Physiotherapy; Telehealth; Telerehabilitation

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders