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Online Education Program in Sportswomen for the Prevention of Stress Urinary Incontinence

Primary Purpose

Incontinence Stress

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational videos
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incontinence Stress focused on measuring Educational pills, Prevention, Sports, Physiotherapy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women between 18 and 35 years old. For the control group who have done sports at least 2 days a week for at least 1 year. For the experimental group who are semi or professional athletes and who carry out high intensity/impact. Exclusion Criteria: Pregnant or postpartum women or who have undergone gynecological and/or urogynecological surgeries. Respiratory, musculoskeletal, metabolic and neurological diseases. A minimum of MMS>21. Refusal to participate or incomplete questionnaires. That they have not been diagnosed with UI of any cause. No mastery or comprehension of the Spanish language.

Sites / Locations

  • Faculty of Physiotherapy of the University of ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity

Low intensity

Arm Description

Women who practice sports professionally.

Women who practice sport in a non-professional way.

Outcomes

Primary Outcome Measures

Knowledge
The validated Spanish PIKQ questionnaire will be used. This questionnaire has good validity and reliability. It is structured in 13 questions with closed answers, that is, "I agree" or "I disagree" answers. These questionnaires evaluate items about UI and prolapses, mainly. Your scoring range is 0 to 1. On each scale, the minimum score is 0 and the maximum is 12.
Knowledge
The validated Spanish PIKQ questionnaire will be used. This questionnaire has good validity and reliability. It is structured in 13 questions with closed answers, that is, "I agree" or "I disagree" answers. These questionnaires evaluate items about UI and prolapses, mainly. Your scoring range is 0 to 1. On each scale, the minimum score is 0 and the maximum is 12.

Secondary Outcome Measures

Motivation
For the perception of exercise, the Markland and Tobin (2004) behavior regulation scale for physical exercise (BREQ-2) will be used. It consists of 19 items, which are answered according to a 5-point Likert-type scale ranging from 0 to (strongly disagree) to 4 (strongly agree), grouped into five factors: demotivation (4 items: e.g., "I don't see the point of exercising"), external regulation (4 items: e.g., "I exercise to pleasing other people"), introjected regulation (3 items: e.g., "I exercise because I feel guilty when I don't practice"), identified regulation (3 items: e.g., "I exercise because I value the benefits of physical exercise ") and intrinsic regulation (4 Items: e.g., "I exercise because I think exercise is fun").
Perception
The perception of change after the intervention was measured using the Patient Global Impression of Change (PGIC) validated in Spanish. This test reflects the patient's belief about the effect of the applied treatment. A scale is used that goes from 1 (the patient is much better) to 7 (the patient is much worse). It also consists of a visual analogue scale that ranked the improvement from 0 to 10, with the first value being a very good improvement and the second being a significant worsening after treatment.
Quality of life of participants
To test the quality of life, the validated questionnaire in Spanish EQ-5D will be used. This is made up of 5 questions with five options and an analog scale from 1 to 100. In this, both physical capacities, such as pain, anxiety and health level.
Adherence
To know the adherence of the patients, a record will be kept of the number of views of each video by group.
Sexual function
To test female sexual function we use the FSFI Questionnaire. This contains 19 questions about sexuality during the last 4 weeks, referring to sexual desire or interest, sexual arousal and satisfaction, among other things. The subscales have a range from 0 (or 1) to 5 (higher scores indicate better sexual function).
Satisfaction after the intervention
A questionnaire of 4-5 questions will be passed in order to collect the satisfaction of the participants after the intervention. Each question will have 5 multiple choices ranging from "strongly disagree" to "strongly agree".

Full Information

First Posted
December 14, 2022
Last Updated
October 12, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05667012
Brief Title
Online Education Program in Sportswomen for the Prevention of Stress Urinary Incontinence
Official Title
Effect of an Online Education Program Through Information Pills in Women Who Practice Sports for the Prevention of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress urinary incontinence (SUI) can be defined through its symptoms as the involuntary loss of urine when carrying out an activity or effort that implies an increase in intra-abdominal pressure (IAP). Perineal dysfunctions are a widespread problem among the sportswomen population. Therefore, a continuous exposure to exercises that entail a high intra-abdominal pressure such as that which occurs in high-impact sports in women. As seen in other studies in which pelvic floor educational programs were taught; advice and guidance focused on perineal health education helped participants improve knowledge, symptoms, and quality of life, as well as reduce the incidence of SUI. For these reasons, it is relevant to carry out a prevention and education program in the female population who play high-impact sports, since they have a high prevalence of SUI.
Detailed Description
Stress urinary incontinence (SUI) can be defined through its symptoms as the involuntary loss of urine when carrying out an activity or effort that implies an increase in intra-abdominal pressure (IAP), for example, coughing, sneezing or performing sports activities that involve hyperpressive gestures. Perineal dysfunctions are a widespread problem among the population. Within these dysfunctions, the presence of stress urinary incontinence can be highlighted, the incidence of which is higher in women. Among its risk factors the investigators find; advanced age, obesity, gynecological surgery, pregnancy and vaginal delivery (increasing the risk if it is an instrumental delivery). On the other hand, although the practice of regular exercise and having an active life is a protective factor for a good physical-functional state, a continuous exposure to exercises that entail a high intra-abdominal pressure such as that which occurs in high-impact sports in women, is another important risk factor to take into account in this population. Of the risk factors, the practice of high-impact sports has also been found, so one in four women who practice different sports classified as high-impact have also ended up developing this pathology. In addition to the problems at the functional level that SUI entails, the impact it has on the quality of life of the people who suffer from it should be emphasized, assuming the patients feelings related to low mood, frustration, discomfort, modesty, etc. Therefore, their work, social and personal lifestyle is also altered. In other studies in which pelvic floor educational programs were taught; advice and guidance focused on perineal health education helped participants improve knowledge, symptoms, and quality of life, as well as reduce the incidence of SUI. This is where physiotherapists intervene, since they have an essential role in the transmission of information regarding its prevention and treatment. For these reasons, it is relevant to carry out a prevention and education program in the female population who play high-impact sports, since they have a high prevalence of SUI, as recommended by the seventh professional principle applied to physiotherapy. Education about the perineal sphere in women reduces the practice of habits that may put their pelvic floor at risk. Despite this, currently in primary care there are not a large number of programs for perineal health. This is demonstrated by different investigations that maintain that almost all the women who participated in them had not consulted their symptoms with anyone or had heard of the pelvic floor muscles or strengthening exercises. Without forgetting that it is increasingly common for women to be present in sports at a professional level, where their demands can favor the increase in the prevalence of suffering from SUI. For this reason, this study intends to observe the effects of a SUI prevention program in female athletes, both low and high level, and check whether there are differences at both levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence Stress
Keywords
Educational pills, Prevention, Sports, Physiotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator analyzing the results will be blinded to the intervention group to which the participants belong.
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity
Arm Type
Experimental
Arm Description
Women who practice sports professionally.
Arm Title
Low intensity
Arm Type
Active Comparator
Arm Description
Women who practice sport in a non-professional way.
Intervention Type
Other
Intervention Name(s)
Educational videos
Intervention Description
There will be a total of 6 videos, each of these videos will last between 8 and 10 minutes and will be accessed through a YouTube link to a private channel.
Primary Outcome Measure Information:
Title
Knowledge
Description
The validated Spanish PIKQ questionnaire will be used. This questionnaire has good validity and reliability. It is structured in 13 questions with closed answers, that is, "I agree" or "I disagree" answers. These questionnaires evaluate items about UI and prolapses, mainly. Your scoring range is 0 to 1. On each scale, the minimum score is 0 and the maximum is 12.
Time Frame
0 week (baseline)
Title
Knowledge
Description
The validated Spanish PIKQ questionnaire will be used. This questionnaire has good validity and reliability. It is structured in 13 questions with closed answers, that is, "I agree" or "I disagree" answers. These questionnaires evaluate items about UI and prolapses, mainly. Your scoring range is 0 to 1. On each scale, the minimum score is 0 and the maximum is 12.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Motivation
Description
For the perception of exercise, the Markland and Tobin (2004) behavior regulation scale for physical exercise (BREQ-2) will be used. It consists of 19 items, which are answered according to a 5-point Likert-type scale ranging from 0 to (strongly disagree) to 4 (strongly agree), grouped into five factors: demotivation (4 items: e.g., "I don't see the point of exercising"), external regulation (4 items: e.g., "I exercise to pleasing other people"), introjected regulation (3 items: e.g., "I exercise because I feel guilty when I don't practice"), identified regulation (3 items: e.g., "I exercise because I value the benefits of physical exercise ") and intrinsic regulation (4 Items: e.g., "I exercise because I think exercise is fun").
Time Frame
0 week (pre), 4 week (post)
Title
Perception
Description
The perception of change after the intervention was measured using the Patient Global Impression of Change (PGIC) validated in Spanish. This test reflects the patient's belief about the effect of the applied treatment. A scale is used that goes from 1 (the patient is much better) to 7 (the patient is much worse). It also consists of a visual analogue scale that ranked the improvement from 0 to 10, with the first value being a very good improvement and the second being a significant worsening after treatment.
Time Frame
0 week (pre), 4 week (post)
Title
Quality of life of participants
Description
To test the quality of life, the validated questionnaire in Spanish EQ-5D will be used. This is made up of 5 questions with five options and an analog scale from 1 to 100. In this, both physical capacities, such as pain, anxiety and health level.
Time Frame
0 week (pre), 4 week (post)
Title
Adherence
Description
To know the adherence of the patients, a record will be kept of the number of views of each video by group.
Time Frame
0 week (pre), 4 week (post)
Title
Sexual function
Description
To test female sexual function we use the FSFI Questionnaire. This contains 19 questions about sexuality during the last 4 weeks, referring to sexual desire or interest, sexual arousal and satisfaction, among other things. The subscales have a range from 0 (or 1) to 5 (higher scores indicate better sexual function).
Time Frame
0 week (pre), 4 week (post)
Title
Satisfaction after the intervention
Description
A questionnaire of 4-5 questions will be passed in order to collect the satisfaction of the participants after the intervention. Each question will have 5 multiple choices ranging from "strongly disagree" to "strongly agree".
Time Frame
0 week (pre), 4 week (post)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women between 18 and 35 years old. For the control group who have done sports at least 2 days a week for at least 1 year. For the experimental group who are semi or professional athletes and who carry out high intensity/impact. Exclusion Criteria: Pregnant or postpartum women or who have undergone gynecological and/or urogynecological surgeries. Respiratory, musculoskeletal, metabolic and neurological diseases. A minimum of MMS>21. Refusal to participate or incomplete questionnaires. That they have not been diagnosed with UI of any cause. No mastery or comprehension of the Spanish language.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Hernández Guillén, PT, PhD
Phone
+34963983853
Ext
51232
Email
david.hernandez@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hernández Guillén, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy of the University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hernández-Guillén, PT, PhD
Phone
963983853
Ext
51232
Email
david.hernandez@uv.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Education Program in Sportswomen for the Prevention of Stress Urinary Incontinence

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