Incontinence StressNCT05667012
Online Education Program in Sportswomen for the Prevention of Stress Urinary Incontinence
A study testing Educational videos in people with Incontinence Stress, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence Stress
- What is being tested?
- Educational videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy of the University of Valencia
Valencia, 46010
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Incontinence Stress
- Being tested
- Educational videos
- Keywords
- Educational pills, Prevention, Sports, Physiotherapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity | Experimental | Women who practice sports professionally. Receives: Other: Educational videos |
| Low intensity | Active comparator | Women who practice sport in a non-professional way. Receives: Other: Educational videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 week (baseline)
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.
Measured: 4 week
Secondary outcomes (6)
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").
Measured: 0 week (pre), 4 week (post)
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.
Measured: 0 week (pre), 4 week (post)
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.
Measured: 0 week (pre), 4 week (post)
Adherence
To know the adherence of the patients, a record will be kept of the number of views of each video by group.
Measured: 0 week (pre), 4 week (post)
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).
Measured: 0 week (pre), 4 week (post)
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".
Measured: 0 week (pre), 4 week (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start2 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incontinence StressStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
- Investigators
- David Hernández Guillén, PT, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667012
- Sponsor's protocol ID
- ED_IU_ONLINE
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuentes-Aparicio L, Dominguez-Navarro F, Maudos-Soriano A, Hernandez-Guillen D. eHealth educational intervention: effects of an online video program in prevention of the pelvic women's health-a non-randomized experimental study. Arch Gynecol Obstet. 2025 Dec;312(6):2153-2164. doi: 10.1007/s00404-025-08200-6. Epub 2025 Oct 3.
PubMed 41042325
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Online Education Program Through Information Pills in Women Who Practice Sports for the Prevention of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05667012
- Acronym / sponsor ID
- ED_IU_ONLINE
- Conditions
- Incontinence Stress
- Keywords
- Educational pills, Prevention, Sports, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity | Experimental | Other: Educational videosWomen who practice sports professionally. |
| Low intensity | Active comparator | Other: Educational videosWomen who practice sport in a non-professional way. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videosThere 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. | Other | High intensity, Low intensity |
Primary outcome
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.
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.
6 secondary outcomes
Motivation
Time frame: 0 week (pre), 4 week (post)
Perception
Time frame: 0 week (pre), 4 week (post)
Quality of life of participants
Time frame: 0 week (pre), 4 week (post)
Adherence
Time frame: 0 week (pre), 4 week (post)
Sexual function
Time frame: 0 week (pre), 4 week (post)
Satisfaction after the intervention
Time frame: 0 week (pre), 4 week (post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41042325Fuentes-Aparicio L, Dominguez-Navarro F, Maudos-Soriano A, Hernandez-Guillen D. eHealth educational intervention: effects of an online video program in prevention of the pelvic women's health-a non-randomized experimental study. Arch Gynecol Obstet. 2025 Dec;312(6):2153-2164. doi: 10.1007/s00404-025-08200-6. Epub 2025 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hernández Guillén, PT, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational videos in people with Incontinence Stress, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: 0 week (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.