NCT06014021: ACTITUD2

Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

Completed NA Last updated 2 April 2024

What this trial tests

NA trial testing Pelvic floor muscle training with biofeedback device in Pelvic Floor Disorders in 45 participants. Completed in 20 November 2023.

Timeline

15 September 2023

Primary endpoint
5 October 2023

20 November 2023

Quick facts

Lead sponsor	University of the Balearic Islands
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	15 September 2023
Primary completion	5 October 2023
Estimated completion	20 November 2023
Sites	1 location across Spain

Drugs / interventions tested

• Pelvic floor muscle training with biofeedback device
• Pelvic floor muscle training
• Information about pelvic floor and communication with health professionals

Conditions studied

• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

University of the Balearic Islands

Who can join

Adults 18 to 45, female only, with Pelvic Floor Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 6-weeks strengthening PF program by using tele-rehabilitation, with or without intracavitary biofeedback, in the PF anatomo-functional characteristics, quality of life and sports performance of female athletes with PFD.

To this end, 45 female athletes with self-reported PFD who train and compete in athletic in Spain will be recruited and randomly distributed in three groups of the experimental study. During 6 weeks, all participants will use an specifically developed Smartphone 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 strengthening program for PF, which will be instructed by 3D avatars, while using an intracavitary biofeedback device that will inform about vaginal pressure; the experimental group 2 (EG2) will be similar to EG1, but they will not use the intracavitary biofeedback device.

Before and after these 6 weeks, anatomo-functional PF characteristics, quality of life, PFD symptoms and sports performance of all participants will be evaluated. As an additional outcome, the level of engagement of the athletes from experimental groups to complete the training program will be registered.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.
   Fernandes ACN, Jorge CH, Weatherall M, Ribeiro IV, et al · · 2025 · cited 6× · PMID 40066950 · DOI 10.1002/14651858.cd009252.pub2