Telehealth in the Rehabilitation of Urinary Incontinence in Older Women

NCT06200922 | Unknown

• 1 other identifier: UFCSPAUI
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence in Old Age

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• Frequency of Urinary Incontinence

  Self-reported frequency of leakage

  Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

• Frequency of Urinary Incontinence.

  Self-reported use of pads.

  Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

• 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.

• 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 Outcomes (3)

• Adherence to the study.

  At the end of the 6th week and at the end of 12 weeks.

• Patient's Satisfaction.

  At the end of 12 weeks.

• Patient's Satisfaction.

  At the end of 12 weeks.

Study Arms (3)

Synchronous Group

EXPERIMENTAL

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

Other: Pelvic physiotherapy

Asynchronous Group

EXPERIMENTAL

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

Other: Pelvic physiotherapy

Face-to-face group

ACTIVE COMPARATOR

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

Other: Pelvic physiotherapy

Interventions

Pelvic physiotherapy 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; Face-to-face group; Synchronous Group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

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

Location

Related Publications (21)

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  PMID: 24839046 BACKGROUND

• 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.

  BACKGROUND

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  PMID: 14595482 BACKGROUND

• 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.

  PMID: 33175229 BACKGROUND

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  PMID: 29145873 BACKGROUND

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  PMID: 27163683 BACKGROUND

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

  BACKGROUND

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  PMID: 20646105 BACKGROUND

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  PMID: 17366526 BACKGROUND

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

  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.

  PMID: 20945012 BACKGROUND

• 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.

  PMID: 27643519 BACKGROUND

• 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.

  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.

  PMID: 29362211 BACKGROUND

• 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.

  PMID: 15243675 BACKGROUND

• 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.

  PMID: 30945991 BACKGROUND

• 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.

  PMID: 28336506 BACKGROUND

• 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.

  BACKGROUND

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  BACKGROUND

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  PMID: 29661052 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luís H. Telles da Rosa

  Federal University of Health Sciences of Porto Alegre (UFCSPA)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluations will be performed by a different researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 11, 2024
• Study Start: April 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: March 20, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)