Telehealth in the Rehabilitation of Urinary Incontinence in Older Women

NCT ID: NCT06200922

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2024-03-20

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.

Conditions

Urinary Incontinence in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Synchronous Group

Will receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist.

Group Type: EXPERIMENTAL

Pelvic physiotherapy

Intervention Type: OTHER

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.

Asynchronous Group

Will receive guidance and perform a pelvic physiotherapy protocol after the evaluation, without the real-time monitoring by the physical therapist

Group Type: EXPERIMENTAL

Pelvic physiotherapy

Intervention Type: OTHER

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.

Face-to-face group

Will receive guidelines and will perform a pelvic physiotherapy protocol oriented in person by the physical therapist.

Group Type: ACTIVE_COMPARATOR

Pelvic physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Luis Henrique Telles da Rosa

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luís H. Telles da Rosa

Role: STUDY_DIRECTOR

Federal University of Health Sciences of Porto Alegre (UFCSPA)

Locations

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Altermann CD, Martins AS, Carpes FP, Mello-Carpes PB. Influence of mental practice and movement observation on motor memory, cognitive function and motor performance in the elderly. Braz J Phys Ther. 2014 Mar-Apr;18(2):201-9. doi: 10.1590/s1413-35552012005000150.

Reference Type: BACKGROUND

PMID: 24839046 (View on PubMed)

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.

Reference Type: BACKGROUND

Bradley CS, Brown JS, Van Den Eeden SK, Schembri M, Ragins A, Thom DH. Urinary incontinence self-report questions: reproducibility and agreement with bladder diary. Int Urogynecol J. 2011 Dec;22(12):1565-71. doi: 10.1007/s00192-011-1503-3. Epub 2011 Jul 28.

Reference Type: BACKGROUND

PMID: 21796472 (View on PubMed)

Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. [Suggestions for utilization of the mini-mental state examination in Brazil]. Arq Neuropsiquiatr. 2003 Sep;61(3B):777-81. doi: 10.1590/s0004-282x2003000500014. Epub 2003 Oct 28. Portuguese.

Reference Type: BACKGROUND

PMID: 14595482 (View on PubMed)

da Mata KRU, Costa RCM, Carbone EDSM, Gimenez MM, Bortolini MAT, Castro RA, Fitz FF. Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review. Int Urogynecol J. 2021 Feb;32(2):249-259. doi: 10.1007/s00192-020-04588-8. Epub 2020 Nov 11.

Reference Type: BACKGROUND

PMID: 33175229 (View on PubMed)

Dumoulin C, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M. Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):544. doi: 10.1186/s13063-017-2261-4.

Reference Type: BACKGROUND

PMID: 29145873 (View on PubMed)

Engberg S, Sereika SM. Effectiveness of Pelvic Floor Muscle Training for Urinary Incontinence: Comparison Within and Between Nonhomebound and Homebound Older Adults. J Wound Ostomy Continence Nurs. 2016 May-Jun;43(3):291-300. doi: 10.1097/WON.0000000000000227.

Reference Type: BACKGROUND

PMID: 27163683 (View on PubMed)

INTERNATIONAL CONTINENCE SOCIETY. International Continence Society fact sheets. [S. l.], n. August, p. 1-40, 2015.

Reference Type: BACKGROUND

Kang HG, Mahoney DF, Hoenig H, Hirth VA, Bonato P, Hajjar I, Lipsitz LA; Center for Integration of Medicine and Innovative Technology Working Group on Advanced Approaches to Physiologic Monitoring for the Aged. In situ monitoring of health in older adults: technologies and issues. J Am Geriatr Soc. 2010 Aug;58(8):1579-86. doi: 10.1111/j.1532-5415.2010.02959.x. Epub 2010 Jul 14.

Reference Type: BACKGROUND

PMID: 20646105 (View on PubMed)

Kincade JE, Dougherty MC, Carlson JR, Hunter GS, Busby-Whitehead J. Randomized clinical trial of efficacy of self-monitoring techniques to treat urinary incontinence in women. Neurourol Urodyn. 2007;26(4):507-511. doi: 10.1002/nau.20413.

Reference Type: BACKGROUND

PMID: 17366526 (View on PubMed)

LEE, Alan et al. Report of the Wcpt / Inptra Digital Physical Therapy Practice Task Force. [S. l.], n. May, p. 1-23, 2019.

Reference Type: BACKGROUND

Pereira SB, Thiel Rdo R, Riccetto C, Silva JM, Pereira LC, Herrmann V, Palma P. [Validation of the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) for Portuguese]. Rev Bras Ginecol Obstet. 2010 Jun;32(6):273-8. doi: 10.1590/s0100-72032010000600004. Portuguese.

Reference Type: BACKGROUND

PMID: 20945012 (View on PubMed)

Poli-Neto OB, Chama PP, Romao AP, Dantas RA, Rosa-E-Silva JC, Candido-Dos-Reis FJ, Nogueira AA. Cultural Adaptation of the Patient Satisfaction Questionnaire and Validation of Its Use in the Portuguese Language for Women with Chronic Pelvic Pain. Rev Bras Ginecol Obstet. 2016 Sep;38(9):443-449. doi: 10.1055/s-0036-1592344. Epub 2016 Sep 19.

Reference Type: BACKGROUND

PMID: 27643519 (View on PubMed)

QUEIROZ, NEILA ALVES DE. TRADUÇÃO E ADAPTAÇÃO CULTURAL DO INTERNATIONAL CONSULTATION ON INCONTINENCE QUESTIONNAIRE FEMALE LOWER URINARY TRACT SYMPTOMS (ICIQ-FLUTS). [S. l.], p. 2, 2016.

Reference Type: BACKGROUND

Rasche P, Wille M, Brohl C, Theis S, Schafer K, Knobe M, Mertens A. Prevalence of Health App Use Among Older Adults in Germany: National Survey. JMIR Mhealth Uhealth. 2018 Jan 23;6(1):e26. doi: 10.2196/mhealth.8619.

Reference Type: BACKGROUND

PMID: 29362211 (View on PubMed)

Tamanini JT, Dambros M, D'Ancona CA, Palma PC, Rodrigues Netto N Jr. [Validation of the "International Consultation on Incontinence Questionnaire -- Short Form" (ICIQ-SF) for Portuguese]. Rev Saude Publica. 2004 Jun;38(3):438-44. doi: 10.1590/s0034-89102004000300015. Epub 2004 Jul 8. Portuguese.

Reference Type: BACKGROUND

PMID: 15243675 (View on PubMed)

Virtuoso JF, Menezes EC, Mazo GZ. Effect of Weight Training with Pelvic Floor Muscle Training in Elderly Women with Urinary Incontinence. Res Q Exerc Sport. 2019 Jun;90(2):141-150. doi: 10.1080/02701367.2019.1571674. Epub 2019 Apr 4.

Reference Type: BACKGROUND

PMID: 30945991 (View on PubMed)

Ware P, Bartlett SJ, Pare G, Symeonidis I, Tannenbaum C, Bartlett G, Poissant L, Ahmed S. Using eHealth Technologies: Interests, Preferences, and Concerns of Older Adults. Interact J Med Res. 2017 Mar 23;6(1):e3. doi: 10.2196/ijmr.4447.

Reference Type: BACKGROUND

PMID: 28336506 (View on PubMed)

WHO. Telemedicine: opportunities and developments in Member States: report on the second global survey on eHealth 2009. Global Observatory for eHealth Series, [S. l.], v. 18, n. 2, p. 153, 2010.

Reference Type: BACKGROUND

WORLD CONFEDERATION FOR PHYSICAL THERAPY. Digital Practice White Paper: Follow Up Survey. In: 2020, Anais [...]. [S. l.: s. n.]

Reference Type: BACKGROUND

Yoon H, Jang Y, Vaughan PW, Garcia M. Older Adults' Internet Use for Health Information: Digital Divide by Race/Ethnicity and Socioeconomic Status. J Appl Gerontol. 2020 Jan;39(1):105-110. doi: 10.1177/0733464818770772. Epub 2018 Apr 16.

Reference Type: BACKGROUND

PMID: 29661052 (View on PubMed)

Related Links

https://www.coffito.gov.br/nsite/?p=15825

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

Other Identifiers

UFCSPAUI

Identifier Type: -

Identifier Source: org_study_id