Validation of iPelvis App for Female Pelvic Floor Dysfunction

Rogério de Fraga

Status: Completed

Conditions: Female Sexual Dysfunction; Urinary Incontinence

Treatments: Behavioral: Home exercise sheet + Pelvic Physiotherapy; Behavioral: Ipelvis mobile application + Pelvic Physiotherapy; Other: Home Exercise Sheet; Other: Ipelvis mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT04484753

Faculdade Inspirar

Details and patient eligibility

About

The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.

Full description

Urinary dysfunctions are widely discussed because they cause problems in social, emotional, sexual life and the quality of life of incontinent women. The overall objective of this research is to evaluate the use of the Application. Ipelvis in women with urinary incontinence. This is a longitudinal study of the type randomized controlled trial. Women with urinary incontinence of urgency, effort and effort will be evaluated and treated. Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic floor musculature function. As volunteers are drawn in four groups (Group I: Household Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).

Enrollment: 138 patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with urinary incontinence by urodynamics, stress and mixed urinary incontinence, aged between 18 and 59 years, who have cognitive ability, have a compatible cell to install the Ipelvis application and who sign the Informed Consent Form.

Exclusion criteria

• Pregnant women, women up to six months postpartum, women with prolapse greater than stage III by Pelvic Organ Prolapse - Quantification (POP-Q), women with urinary tract infection, women with pelvic pain Performing therapies offered or having undergone pelvic surgery within a period of less than six months; With a pacemaker or contraceptive device (IUD); Women with intrapelvic tumor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 4 patient groups

Home Exercise Sheet

Other group

Description:

The participant took the sheet with the description of the exercises to his address.

Treatment:

Other: Home Exercise Sheet

Ipelvis mobile application

Other group

Description:

The participant received the app and performs home exercises guided by the app.

Treatment:

Other: Ipelvis mobile application

Home exercise sheet + Pelvic Physiotherapy

Active Comparator group

Description:

The participant did group physical therapy and used the exercise sheet at home on other days.

Treatment:

Behavioral: Home exercise sheet + Pelvic Physiotherapy

Ipelvis mobile application + Pelvic Physiotherapy

Active Comparator group

Description:

The participant did group physical therapy and used the mobile application on other days.

Treatment:

Behavioral: Ipelvis mobile application + Pelvic Physiotherapy