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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114395
• Other study ID #: CE 114-21
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: August 9, 2021

Study information

• Verified date: November 2021
• Source: Centro Hospitalar De São João, E.P.E.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 9, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Enuresis
• Incontinence, Urinary
• Muscle Weakness
• Pelvic Floor Muscle Weakness
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Pelvic Floor Telerehabilitation Program
See experimental and active comparator arms.
• Pelvic Floor Face-to-Face Program
See experimental and active comparator arms.

Locations

Country	Name	City	State
Portugal	Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João	Porto
Portugal	Susana Cristina Alves Moreira	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar De São João, E.P.E.

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Carrión Pérez F, Rodríguez Moreno MS, Carnerero Córdoba L, Romero Garrido MC, Quintana Tirado L, García 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. — View 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. — View 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. — View Citation

Hay-Smith EJ, Bø 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. Review. Update in: Cochrane Database Syst Rev. 2006;(1):CD001407. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.