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NCT Number: NCT05114395

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

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.

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Key information

Conditions

Stress Urinary Incontinence COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Urinary Infections Lower Urinary Tract Symptoms Lung Diseases Male Urogenital Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Weakness Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Virus Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João, Porto, Portugal

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Floor Telerehabilitation Program

Other

See experimental and active comparator arms.

Pelvic Floor Face-to-Face Program

Other

See experimental and active comparator arms.

Primary outcomes

  1. Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).

    Time frame: From admission to discharge of the program, up to 13 weeks.

    The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ.

Secondary outcomes

  1. Assessment of UI severity.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    Assessment of UI severity using the International Continence Society (ICS) pad test.

  2. Evaluation of the global perception of improvement of the patient.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    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.

  3. Evaluation of sexual function.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    Evaluation of sexual function using the Portuguese version of the Female Sexual Functioning Index (FSFI)

  4. Assessment of the presence of symptoms of depression/anxiety.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    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.

  5. Assessment of satisfaction with the treatment.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    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.

  6. Assessment of adherence to the treatment.

    Time frame: From admission to discharge of the program, up to 13 weeks.

    Assessment of adherence to the treatment including compliance to the exercise program (number of performed sessions) and to the behavioral measures.

  7. Assessment of UI severity.

    Time frame: From admission to discharge of the program, up to 16 weeks.

    Assessment of UI severity using the Portuguese version of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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