Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times

Conditions
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Covid19, Stress Urinary Incontinence, Incontinence, Urinary, Pelvic Floor Muscle Weakness

Intervention / Treatment
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* Other: Pelvic Floor Telerehabilitation Program
* Other: Pelvic Floor Face-to-Face Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation Group<br>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. | Other: Pelvic Floor Telerehabilitation Program<br>* See experimental and active comparator arms.<br>|
| Active Comparator: Face-to-Face Group<br>The control group develops the entire program in face-to-face consultations and exercise sessions. | Other: Pelvic Floor Face-to-Face Program<br>* See experimental and active comparator arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ). | The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ. | From admission to discharge of the program, up to 13 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of UI severity. | Assessment of UI severity using the International Continence Society (ICS) pad test. | From admission to discharge of the program, up to 13 weeks. | 
| Evaluation of the global perception of improvement of the patient. | Evaluation of the global perception of improvement of the patient using the Portuguese version of the Patient Global Impression of Improvement (PGI-I) Scale. The minimum value is 0 and the maximum is 10. A higher score means a better outcome. | From admission to discharge of the program, up to 13 weeks. | 
| Evaluation of sexual function. | Evaluation of sexual function using the Portuguese version of the Female Sexual Functioning Index (FSFI) | From admission to discharge of the program, up to 13 weeks. | 
| Assessment of the presence of symptoms of depression/anxiety. | Assessment of the presence of symptoms of depression/anxiety using the Portuguese version of the Hospital Anxiety & Depression Scale (HADS) questionnaire. The minimum value is 0 and the maximum is 21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | From admission to discharge of the program, up to 13 weeks. | 
| Assessment of satisfaction with the treatment. | Assessment of satisfaction with the treatment using the 9-point Likert scale. The minimum value is 1 and the maximum is 9. A higher score means a better outcome. | From admission to discharge of the program, up to 13 weeks. | 
| Assessment of adherence to the treatment. | Assessment of adherence to the treatment including compliance to the exercise program (number of performed sessions) and to the behavioral measures. | From admission to discharge of the program, up to 13 weeks. | 
| Assessment of UI severity. | Assessment of UI severity using the Portuguese version of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). | From admission to discharge of the program, up to 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor, Physical therapy, Urinary incontinence, Quality of life, Telerehabilitation, Training, Pelvic floor musculature, Female, Pelvic Floor Muscle Training