Telehealth in the Rehabilitation of Urinary Incontinence in Older Women

Urinary Incontinence in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06200922
• Other study ID #: UFCSPAUI
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: January 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: March 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence in Old Age

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (21)

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Urinary Incontinence.	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.
Primary	Type of Urinary Incontinence.	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.
Primary	Frequency of Urinary Incontinence	Self-reported frequency of leakage	Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Primary	Frequency of Urinary Incontinence.	Self-reported use of pads.	Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Primary	Overactive bladder symptoms.	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.
Primary	Quality of Life.	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	Adherence to the study.	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.
Secondary	Patient's Satisfaction.	Application of The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS).	At the end of 12 weeks.
Secondary	Patient's Satisfaction.	Application of The TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)	At the end of 12 weeks.

External Links

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