Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program
NCT ID: NCT05114395
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2021-03-08
2021-08-09
Brief Summary
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About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common.
Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it.
Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date.
The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.
Detailed Description
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Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be randomized one to one between the intervention group and the control group.
The intervention group includes a hybrid program of face-to-face sessions followed by sessions of video, while the control group develops the entire program in face-to-face sessions.
The effectiveness of the program will be assessed by the results in the UI-related quality of life (primary outcome); UI severity, patient's overall perception of improvement, sexual function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary outcomes).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Telerehabilitation Group
The intervention group includes a hybrid program of face-to-face sessions and video sessions. In the first consultation, a face-to-face one, patients will be instructed with behavioral and lifestyle measures and it will be prescribed a 12-week exercise program, including exercises to be performed three times a day and two weekly exercise sessions - three face-to-face sessions (2 initial and one at 8 weeks) and video sessions of 30 minutes, divided into 3 phases with gradual addition of exercises of increasing difficulty in terms of duration, number of repetitions and positions.
In the middle of the treatment (at 6 weeks) a medical teleconsultation is performed for reassessment. In the end of the 12-week program there will also be a face-to-face consultation.
Pelvic Floor Telerehabilitation Program
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Face-to-Face Group
The control group develops the entire program in face-to-face consultations and exercise sessions.
Pelvic Floor Face-to-Face Program
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Interventions
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Pelvic Floor Telerehabilitation Program
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Pelvic Floor Face-to-Face Program
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Eligibility Criteria
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Inclusion Criteria
* Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
* Capable of understanding and executing the therapeutic program and expressing agreement to participate in the study after free and informed consent
Exclusion Criteria
* Pregnant women
* Submitted to conservative or surgical treatment of UI in the last 12 months
* Active urinary tract infection
* Macroscopic hematuria
* Neurogenic dysfunction of the lower urinary tract
* Cognitive deficit
* Osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
* Active pelvic neoplasia
* Pelvic organ prolapse grade greater than or equal to 2
* Impossibility of access or illiteracy to technological means (phone or computer)
* Unavailable to attend the face-to-face program due to accessibility, schedule, economic reasons or fear of the pandemic context
18 Years
65 Years
FEMALE
No
Sponsors
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Centro Hospitalar De São João, E.P.E.
OTHER
Responsible Party
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Susana Moreira
Medical Doctor
Principal Investigators
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Susana Moreira
Role: PRINCIPAL_INVESTIGATOR
Centro Hospitalar Universitário São João
Locations
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Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João
Porto, , Portugal
Susana Cristina Alves Moreira
Porto, , Portugal
Countries
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References
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D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
Correia S, Dinis P, Rolo F, Lunet N. Prevalence, treatment and known risk factors of urinary incontinence and overactive bladder in the non-institutionalized Portuguese population. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Dec;20(12):1481-9. doi: 10.1007/s00192-009-0975-x. Epub 2009 Aug 14.
Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
Carrion Perez F, Rodriguez Moreno MS, Carnerero Cordoba L, Romero Garrido MC, Quintana Tirado L, Garcia Montes I. [Telerehabilitation to treat stress urinary incontinence. Pilot study]. Med Clin (Barc). 2015 May 21;144(10):445-8. doi: 10.1016/j.medcli.2014.05.036. Epub 2014 Jul 30. Spanish.
Santiago M, Cardoso-Teixeira P, Pereira S, Firmino-Machado J, Moreira S. A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic. Int Urogynecol J. 2023 Mar;34(3):717-727. doi: 10.1007/s00192-022-05108-6. Epub 2022 May 21.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CE 114-21
Identifier Type: -
Identifier Source: org_study_id