Urinary Incontinence in Old AgeNCT06200922
Telehealth in the Rehabilitation of Urinary Incontinence in Older Women
A study testing Pelvic physiotherapy in people with Urinary Incontinence in Old Age, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years, women only
- Conditions the study is for
- Urinary Incontinence in Old Age
- What is being tested?
- Pelvic physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2022to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years old or more;
- Urinary Incontinence for at least 12 months
- Internet access.
Who cannot join
- Pelvic cancer;
- Sling surgery;
- Urinary catheter;
- Antimuscarinic medication;
- Alzheimer;
- Parkinson;
- Multiple Sclerosis;
- Uncontrolled diabetes.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial
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.
Read the 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
- Being tested
- Pelvic physiotherapy
- Keywords
- Urinary Incontinence, Old Age, Pelvic Physiotherapy, Telehealth, Telerehabilitation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic physiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| Synchronous Group | Experimental | Will receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist. Receives: 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 Receives: 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. Receives: Other: Pelvic physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Urinary Incontinence.
Application of The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Measured: 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?
Measured: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Frequency of Urinary Incontinence
Self-reported frequency of leakage
Measured: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Frequency of Urinary Incontinence.
Self-reported use of pads.
Measured: 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)
Measured: 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).
Measured: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.
Secondary outcomes (3)
Adherence to the study.
Self-reported adherence to the protocol:
Patients will report how many days they performed the guided exercises.
Measured: At the end of the 6th week and at the end of 12 weeks.
Patient's Satisfaction.
Application of The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS).
Measured: At the end of 12 weeks.
Patient's Satisfaction.
Application of The TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)
Measured: At the end of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Apr 2022
- Primary completion20 Dec 2023
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre
- Investigators
- Luís H. Telles da Rosa, Study director, Federal University of Health Sciences of Porto Alegre (UFCSPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200922
- Sponsor's protocol ID
- UFCSPAUI
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24839046BØ, K. et al. Evidence-Based Physical Therapy for the Pelvic Floor: Bridging Science and Clinical Practice. 2. ed. London: Churchill Livingstone, 2015. E-book.
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.
PubMed 21796472Brucki 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.
PubMed 14595482da 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.
PubMed 33175229Dumoulin 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.
PubMed 29145873Engberg 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.
PubMed 27163683INTERNATIONAL CONTINENCE SOCIETY. International Continence Society fact sheets. [S. l.], n. August, p. 1-40, 2015.
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.
PubMed 20646105Kincade 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.
PubMed 17366526LEE, Alan et al. Report of the Wcpt / Inptra Digital Physical Therapy Practice Task Force. [S. l.], n. May, p. 1-23, 2019.
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.
PubMed 20945012Poli-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.
PubMed 27643519QUEIROZ, 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.
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.
PubMed 29362211
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06200922
- Acronym / sponsor ID
- UFCSPAUI
- Conditions
- Urinary Incontinence in Old Age
- Keywords
- Urinary Incontinence, Old Age, Pelvic Physiotherapy, Telehealth, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Synchronous Group | Experimental | Other: Pelvic physiotherapyWill receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist. |
| Asynchronous Group | Experimental | Other: Pelvic physiotherapyWill receive guidance and perform a pelvic physiotherapy protocol after the evaluation, without the real-time monitoring by the physical therapist |
| Face-to-face group | Active comparator | Other: Pelvic physiotherapyWill receive guidelines and will perform a pelvic physiotherapy protocol oriented in person by the physical therapist. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years old or more;
- Urinary Incontinence for at least 12 months
- Internet access.
Key exclusion criteria (8 listed)
- Pelvic cancer;
- Sling surgery;
- Urinary catheter;
- Antimuscarinic medication;
- Alzheimer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic physiotherapyAll 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. | Other | Asynchronous Group, Face-to-face group, Synchronous Group |
Primary outcome
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)
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?
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
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.
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)
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).
3 secondary outcomes
Adherence to the study.
Time frame: At the end of the 6th week and at the end of 12 weeks.
Patient's Satisfaction.
Time frame: At the end of 12 weeks.
Patient's Satisfaction.
Time frame: At the end of 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 24839046Altermann 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.
- BackgroundBØ, 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: PubMed 21796472Bradley 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.
- Background: PubMed 14595482Brucki 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.
- Background: PubMed 33175229da 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.
- Background: PubMed 29145873Dumoulin 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.
- Background: PubMed 27163683Engberg 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.
- BackgroundINTERNATIONAL CONTINENCE SOCIETY. International Continence Society fact sheets. [S. l.], n. August, p. 1-40, 2015.
- Background: PubMed 20646105Kang 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.
- Background: PubMed 17366526Kincade 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.
- BackgroundLEE, Alan et al. Report of the Wcpt / Inptra Digital Physical Therapy Practice Task Force. [S. l.], n. May, p. 1-23, 2019.
- Background: PubMed 20945012Pereira 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.
- Federal Council of Physiotherapy and Occupational Therapy resolution about the practice of telehealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luís H. Telles da Rosa study director
Federal University of Health Sciences of Porto Alegre (UFCSPA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic physiotherapy in people with Urinary Incontinence in Old Age, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Urinary Incontinence. (time frame: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200922, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.