Validation of iPelvis App for Female Pelvic Floor Dysfunction

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Female Sexual Dysfunction
• Intervention / Treatment: Other: Home Exercise Sheet; Other: Ipelvis mobile application; Behavioral: Home exercise sheet + Pelvic Physiotherapy; Behavioral: Ipelvis mobile application + Pelvic Physiotherapy

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kings Health Questionnaire (KHQ)	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.	3 Months
The Female Sexual Function Index (FSFI)	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.	3 Months

Collaborators and Investigators

• Sponsor: Rogério de Fraga
• Investigators: Study Director: Rogério Fraga, Faculdade Inspirar

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2017
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; adherence; urinary incontinence; female sexual dysfunction; pelvic physiotherapy; post-partum
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: Faculdade Inspirar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No