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

Primary Purpose

Stress Urinary Incontinence, Incontinence, Urinary, Covid19

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Pelvic Floor Telerehabilitation Program

Pelvic Floor Face-to-Face Program

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Pelvic floor, Physical therapy, Urinary incontinence, Quality of life, Telerehabilitation, Training, Pelvic floor musculature, Female, Pelvic Floor Muscle Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João
Susana Cristina Alves Moreira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation Group

Face-to-Face Group

Arm Description

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.

The control group develops the entire program in face-to-face consultations and exercise sessions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of UI severity.

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

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.

Evaluation of sexual function.

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

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.

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.

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.

Assessment of UI severity.

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

Full Information

NCT ID

NCT05114395

First Posted

May 26, 2021

Last Updated

November 5, 2021

Sponsor

Centro Hospitalar De São João, E.P.E.

1. Study Identification

Unique Protocol Identification Number

NCT05114395

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Hospitalar De São João, E.P.E.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telerehabilitation Group

Arm Type

Experimental

Arm Description

Arm Title

Face-to-Face Group

Arm Type

Active Comparator

Arm Description

The control group develops the entire program in face-to-face consultations and exercise sessions.

Intervention Type

Other

Intervention Name(s)

Pelvic Floor Telerehabilitation Program

Intervention Description

See experimental and active comparator arms.

Intervention Type

Other

Intervention Name(s)

Pelvic Floor Face-to-Face Program

Intervention Description

See experimental and active comparator arms.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Assessment of UI severity.

Description

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

Time Frame

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

Title

Evaluation of the global perception of improvement of the patient.

Description

Time Frame

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

Title

Evaluation of sexual function.

Description

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

Time Frame

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

Title

Assessment of the presence of symptoms of depression/anxiety.

Description

Time Frame

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

Title

Assessment of satisfaction with the treatment.

Description

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.

Time Frame

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

Title

Assessment of adherence to the treatment.

Description

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

Time Frame

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

Title

Assessment of UI severity.

Description

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

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susana Moreira

Organizational Affiliation

Centro Hospitalar Universitário São João

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Susana Cristina Alves Moreira

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30681183

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.

Results Reference

background

PubMed Identifier

19684999

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.

Results Reference

background

PubMed Identifier

11279716

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.

Results Reference

background

PubMed Identifier

25087210

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.

Results Reference

background

PubMed Identifier

35596802

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.

Results Reference

derived

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

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