Validation of iPelvis App for Female Pelvic Floor Dysfunction

Sponsor

Rogério de Fraga (Other)

Overall Status

Completed

CT.gov ID

NCT04484753

Collaborator

(none)

138

Enrollment

Arms

22.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Sexual Dysfunction Urinary Incontinence	Other: Home Exercise Sheet Other: Ipelvis mobile application Behavioral: Home exercise sheet + Pelvic Physiotherapy Behavioral: Ipelvis mobile application + Pelvic Physiotherapy	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Validation of the iPelvis Mobile Application for Pelvic Physiotherapy in Women With Female Pelvic Floor Dysfunction

Actual Study Start Date :

Jan 9, 2017

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Home Exercise Sheet The participant took the sheet with the description of the exercises to his address.	Other: Home Exercise Sheet Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
Other: Ipelvis mobile application The participant received the app and performs home exercises guided by the app.	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.
Active Comparator: Home exercise sheet + Pelvic Physiotherapy The participant did group physical therapy and used the exercise sheet at home on other days.	Behavioral: 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.
Active Comparator: Ipelvis mobile application + Pelvic Physiotherapy The participant did group physical therapy and used the mobile application on other days.	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.

Outcome Measures

Primary Outcome Measures

International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) [3 Months]
A tool that assesses the impact of UI on the quality of life and severity of urinary symptoms. The questionnaire is composed of four questions related to frequency, severity of urinary loss and its impact on quality of life. The ICIQ score is the sum of the scores from questions three, four and five and ranges from 0 to 21.

Secondary Outcome Measures

Kings Health Questionnaire (KHQ) [3 Months]
A questionnaire that analyzes the presence of Urinary Incontinence symptoms and their impact on various aspects of individuality in quality of life. The questionnaire is composed of 30 questions subdivided into nine domains. They report, respectively, the general perception of health, the impact of incontinence, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, and severity measures. To achieve the overall KHQ score, some pre-established calculations were performed, which provided scores for subsequent correlations.
The Female Sexual Function Index (FSFI) [3 Months]
The questionnaire consists of 19 questions, which provide information on five domains of sexual response: desire and subjective stimulation, lubrication, orgasm, satisfaction and pain or discomfort. Individual scores are considered by the sum of items that comprise each domain (simple score), which are multiplied by the factor of that domain and can be explored or weighted. A final score (total scores: minimum of 2 and maximum of 36) is the total value of weighted scores for each domain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

Female

Accepts 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.