Clinical trial NCT05114395: Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program
Official title: Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Incontinence, Urinary
Covid19
Pelvic Floor Muscle Weakness
Keywords: Pelvic floor
Physical therapy
Urinary incontinence
Quality of life
Telerehabilitation
Training
Pelvic floor musculature
Female
Pelvic Floor Muscle Training
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function.

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: Randomized longitudinal study including consecutively admitted patients on pelvic floor rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro Hospitalar São João for conservative treatment of UI.

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).

Eligibility criteria: Inclusion Criteria:

* Female patients aged between 18 and 65 years with SUI or MUI with a predominance of SUI with at least 1 urinary incontinence episode per week in the last month
* 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:

* Patients with urgency urinary incontinence or MUI with a predominance of urgency
* 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

Primary outcomes:
measure: Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
timeFrame: From admission to discharge of the program, up to 13 weeks.
Secondary outcomes:
measure: Assessment of UI severity.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Evaluation of the global perception of improvement of the patient.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Evaluation of sexual function.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Assessment of the presence of symptoms of depression/anxiety.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Assessment of satisfaction with the treatment.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Assessment of adherence to the treatment.
timeFrame: From admission to discharge of the program, up to 13 weeks.
measure: Assessment of UI severity.
timeFrame: From admission to discharge of the program, up to 16 weeks.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João
city: Porto
country: Portugal
facility: Susana Cristina Alves Moreira
Study officials:
affiliation: Centro Hospitalar Universitário São João
name: Susana Moreira
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.