Clinical trial NCT06200922: Telehealth in the Rehabilitation of Urinary Incontinence in Older Women
Official title: Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence in Old Age
Keywords: Urinary Incontinence
Old Age
Pelvic Physiotherapy
Telehealth
Telerehabilitation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 69
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Presence of Urinary Incontinence.
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
measure: Type of Urinary Incontinence.
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
measure: Frequency of Urinary Incontinence
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
measure: Frequency of Urinary Incontinence.
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
measure: Overactive bladder symptoms.
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
measure: Quality of Life.
timeFrame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Secondary outcomes:
measure: Adherence to the study.
timeFrame: At the end of the 6th week and at the end of 12 weeks.
measure: Patient's Satisfaction.
timeFrame: At the end of 12 weeks.
measure: Patient's Satisfaction.
timeFrame: At the end of 12 weeks.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre (UFCSPA)
name: Luís H. Telles da Rosa
role: STUDY_DIRECTOR
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