Evaluation of the Ipelvis Application in Women's Urinary Loss

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7pc86g
• Date of registration: 21/05/2018
• Prospective Registration: No
• Primary sponsor: Faculdade Inspirar
• Public title: Evaluation of the Ipelvis Application in Women's Urinary Loss
• Scientific title: Evaluation of the Ipelvis Application on feminine urinary disfunctions
• Date of first enrolment: 09/01/2017
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7pc86g
• Study type: Intervention
• Study design: Clinical trial of treatment, randomized-controlled, factorial, open, with four arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Cíntia Fischer Blosfeld
• Affiliation: Faculdade Inspirar

• Name: Rogério de Fraga
• Affiliation: Hospital de Clínicas - Universidade Federal do Paraná

Key inclusion & exclusion criteria

Inclusion criteria: Urinary urgency; stress and mixed urinary incontinence; with ages between 18 and 59 years, with objective demonstration of urinary loss that have cognitive ability; have a compatible cell phone for installation of the Ipelvis application and who sign the Informed Consent Term
Exclusion criteria: They shall be excluded from the statistical analysis women with up to six months postpartum; women with prolapse greater than Stage III by Pelvic Organ Prolapse - Quantification; women with urinary tract infection; women with pelvic pain that prevent achievement Of therapies offered or who have undergone pelvic surgery in a period of less than six months; Pacemaker or contraceptive device; Women with intrapelvic tumor

Age minimum: 18Y
Age maximum: 59Y
Gender: F

Health Condition(s) or Problem(s) studied

C12.777.934.852

C12.777.934.852.249

Urinary Incontinence, Urgency Urinary Incontinence; Urinary Stress Incontinence.

C12.777.934.852.500

Intervention(s)

Other

H02.010.625

Control Group: 35 volunteers will receive a sheet with exercises guidelines for Pelvic Floor Musculature (MAP) to be performed during 3 months at home;
Experimental Group I: 35 volunteers will receive the Ipelvis application with exercise guidelines for MAP to be performed during 3 months at home;
Experimental Group II: 35 volunteers will perform 12 sessions of 45 minutes, once a week, of Pelvic Physiotherapy in groups of a maximum of 10 participants. During the visits, exercises will be performed for the MAP. In addition, each volunteer will receive a sheet with exercise guidelines for MAP to be performed at home.
Experimental Group IV: 35 volunteers will perform 12 sessions of 45 minutes, once a week, of Pelvic Physiotherapy in groups of a maximum of 10 participants. During the visits, exercises will be performed for the MAP. In addition, they will receive the Ipelvis application with exercise guidelines for the MAP to be performed at home.
The Ipelvis Application (APP) will be presented to the volunteers of Groups II and IV by the team of researchers, as well as will be guided its installation in the mobile device of each volunteer, who will receive a password. A locking system has been created for use on other computers or
phones, allowing the individualization of the system.
The training in the pelvic floor of all the groups mentioned will follow a logical sequence of increase of intensity and repetitions of physiological form that provide increase of the muscular strength and diminution of the symptoms of urinary incontinence, as it appears in the current protocols with degree of evidence

Primary Outcome(s)

Improvement of urinary symptoms, determined through the International Consultation on Incontinence Questionnaire, at the beginning and at the end of the study

Secondary Outcome(s)

Adherence of the patients to the physiotherapeutic treatment, related to the reduction or not of the urinary symptoms

Source(s) of Monetary Support

Faculdade Inspirar

Secondary Sponsor(s)

Hospital de Clínicas - Universidade Federal do Paraná