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Completed

NCT Number: NCT04484753

Validation of iPelvis App for 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.

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Key information

Conditions

Female Sexual Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Exercise Sheet

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

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

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

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.

Primary outcomes

  1. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

    Time frame: 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 outcomes

  1. Kings Health Questionnaire (KHQ)

    Time frame: 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.

  2. The Female Sexual Function Index (FSFI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rogério de Fraga

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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