A Mobile Application for Female Athletes With Pelvic Floor Dysfunctions (ACTITUD2.0)

University of the Balearic Islands

Status: Completed

Conditions: Pelvic Floor Disorders

Treatments: Behavioral: Information about pelvic floor and communication with health professionals; Behavioral: Pelvic floor exercises program; Behavioral: Pelvic floor exercises program guided with an intravaginal biofeedback device

Study type: Interventional

Funder types: Other

Identifiers

NCT06814743

124CER19_2.0

Details and patient eligibility

About

Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.

This study will evaluate the effects of a 12-weeks program with exercises focused on PF awareness and strengthening by using a mobile application supervised by physiotherapists, with or without intracavitary biofeedback, on the PF anatomical and functional characteristics, symptomatology and sports performance of female athletes with PFD.

To this end, 105 female athletes with self-reported PFD who train and compete in sport in Spain will be recruited and randomly distributed in three groups of the experimental study. During 12 weeks, all participants will use the mobile application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a the exercise program for PF; the experimental group 2 (EG2) will be similar to EG1, but they will use an intravaginal biofeedback device during exercises to receive information about their intra-vaginal pressure.

Before and after these 12 weeks, anatomical and functional PF characteristics, PF symptoms and sports performance of all participants will be evaluated. As additional outcome, the compliance of the athletes from experimental groups to complete the training program will be registered (in %).

Full description

Female athletes from EG1 and EG2 will complete the exercise program for PF three times per week, during 12 weeks. Each session will last about 20 minutes and exercises will be modified every two weeks to meet the principle of training progression and avoid athletes become bored.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To train and compete in any sport.
• To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).

Exclusion criteria

• To have recurrent infections of urinary tract during the last three months.
• To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
• To have been pregnant during the year prior to the start of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 3 patient groups

Experimental group 2: Exercises with biofeedback guidance

Experimental group

Description:

All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor, while using an intravaginal biofeedback device.

Treatment:

Behavioral: Pelvic floor exercises program guided with an intravaginal biofeedback device

Behavioral: Information about pelvic floor and communication with health professionals

Behavioral: Pelvic floor exercises program

Experimental group 1: Exercises

Active Comparator group

Description:

All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor.

Treatment:

Behavioral: Information about pelvic floor and communication with health professionals

Behavioral: Pelvic floor exercises program

Control group: No exercises

Active Comparator group

Description:

All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team.

Treatment:

Behavioral: Information about pelvic floor and communication with health professionals