- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05667012
Online Education Program in Sportswomen for the Prevention of Stress Urinary Incontinence
Effect of an Online Education Program Through Information Pills in Women Who Practice Sports for the Prevention of Stress Urinary Incontinence
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.
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Hernández Guillén, PT, PhD
- Phone Number: 51232 +34963983853
- Email: david.hernandez@uv.es
Study Locations
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-
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Valencia, Spain, 46010
- Recruiting
- Faculty of Physiotherapy of the University of Valencia
-
Contact:
- David Hernández-Guillén, PT, PhD
- Phone Number: 51232 963983853
- Email: david.hernandez@uv.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity
Women who practice sports professionally.
|
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.
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Active Comparator: Low intensity
Women who practice sport in a non-professional way.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge
Time Frame: 0 week (baseline)
|
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.
|
0 week (baseline)
|
Knowledge
Time Frame: 4 week
|
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.
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation
Time Frame: 0 week (pre), 4 week (post)
|
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").
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0 week (pre), 4 week (post)
|
Perception
Time Frame: 0 week (pre), 4 week (post)
|
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.
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0 week (pre), 4 week (post)
|
Quality of life of participants
Time Frame: 0 week (pre), 4 week (post)
|
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.
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0 week (pre), 4 week (post)
|
Adherence
Time Frame: 0 week (pre), 4 week (post)
|
To know the adherence of the patients, a record will be kept of the number of views of each video by group.
|
0 week (pre), 4 week (post)
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Sexual function
Time Frame: 0 week (pre), 4 week (post)
|
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).
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0 week (pre), 4 week (post)
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Satisfaction after the intervention
Time Frame: 0 week (pre), 4 week (post)
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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".
|
0 week (pre), 4 week (post)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Hernández Guillén, PT, PhD, University of Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- ED_IU_ONLINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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