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

Centro Hospitalar De São João, E.P.E.

Status: Completed

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

Treatments: Other: Pelvic Floor Face-to-Face Program; Other: Pelvic Floor Telerehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05114395

CE 114-21

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Telerehabilitation Group

Experimental group

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.

Treatment:

Other: Pelvic Floor Telerehabilitation Program

Face-to-Face Group

Active Comparator group

Description:

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

Treatment:

Other: Pelvic Floor Face-to-Face Program