Back to resultsValidation of iPelvis App for Female Pelvic Floor Dysfunction
Primary Purpose
Female Sexual Dysfunction, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Exercise Sheet
Ipelvis mobile application
Home exercise sheet + Pelvic Physiotherapy
Ipelvis mobile application + Pelvic Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Female Sexual Dysfunction focused on measuring urinary incontinence, female sexual dysfunction, quality of life, adherence, pelvic physiotherapy, post-partum
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Active Comparator
Active Comparator
Arm Label
Home Exercise Sheet
Ipelvis mobile application
Home exercise sheet + Pelvic Physiotherapy
Ipelvis mobile application + Pelvic Physiotherapy
Arm Description
The participant took the sheet with the description of the exercises to his address.
The participant received the app and performs home exercises guided by the app.
The participant did group physical therapy and used the exercise sheet at home on other days.
The participant did group physical therapy and used the mobile application on other days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04484753
Brief Title
Validation of iPelvis App for Female Pelvic Floor Dysfunction
Official Title
Validation of the iPelvis Mobile Application for Pelvic Physiotherapy in Women With Female Pelvic Floor Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rogério de Fraga
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Dysfunction, Urinary Incontinence
Keywords
urinary incontinence, female sexual dysfunction, quality of life, adherence, pelvic physiotherapy, post-partum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise Sheet
Arm Type
Other
Arm Description
The participant took the sheet with the description of the exercises to his address.
Arm Title
Ipelvis mobile application
Arm Type
Other
Arm Description
The participant received the app and performs home exercises guided by the app.
Arm Title
Home exercise sheet + Pelvic Physiotherapy
Arm Type
Active Comparator
Arm Description
The participant did group physical therapy and used the exercise sheet at home on other days.
Arm Title
Ipelvis mobile application + Pelvic Physiotherapy
Arm Type
Active Comparator
Arm Description
The participant did group physical therapy and used the mobile application on other days.
Intervention Type
Other
Intervention Name(s)
Home Exercise Sheet
Intervention Description
Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
Intervention Type
Other
Intervention Name(s)
Ipelvis mobile application
Intervention Description
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
Intervention Name(s)
Home exercise sheet + Pelvic Physiotherapy
Intervention Description
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
Intervention Name(s)
Ipelvis mobile application + Pelvic Physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Kings Health Questionnaire (KHQ)
Description
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.
Time Frame
3 Months
Title
The Female Sexual Function Index (FSFI)
Description
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.
Time Frame
3 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogério Fraga
Organizational Affiliation
Faculdade Inspirar
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of iPelvis App for Female Pelvic Floor Dysfunction
We'll reach out to this number within 24 hrs