Validation of iPelvis App for Female Pelvic Floor Dysfunction

NCT ID: NCT04484753

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2018-12-01

Brief Summary

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.

Detailed 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).

Conditions

Female Sexual Dysfunction; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home Exercise Sheet

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

Group Type: OTHER

Home Exercise Sheet

Intervention Type: OTHER

Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Ipelvis mobile application

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

Group Type: OTHER

Ipelvis mobile application

Intervention Type: OTHER

Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Home exercise sheet + Pelvic Physiotherapy

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

Group Type: ACTIVE_COMPARATOR

Home exercise sheet + Pelvic Physiotherapy

Intervention Type: BEHAVIORAL

Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Ipelvis mobile application + Pelvic Physiotherapy

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

Group Type: ACTIVE_COMPARATOR

Ipelvis mobile application + Pelvic Physiotherapy

Intervention Type: BEHAVIORAL

Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Interventions

Home Exercise Sheet

Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Intervention Type: OTHER

Ipelvis mobile application

Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Intervention Type: OTHER

Home exercise sheet + Pelvic Physiotherapy

Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Intervention Type: BEHAVIORAL

Ipelvis mobile application + Pelvic Physiotherapy

Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rogério de Fraga

OTHER

Sponsor Role: lead

Responsible Party

Rogério de Fraga

director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rogério Fraga

Role: STUDY_DIRECTOR

Faculdade Inspirar

References

Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

Faculdade Inspirar

Identifier Type: -

Identifier Source: org_study_id