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CompletedNCT05667012Updated Dec 6, 2024

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

An interventional study of Educational videos in Incontinence Stress, sponsored by University of Valencia. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Valencia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Incontinence Stress

Keywords

  • Educational pills
  • Prevention
  • Sports
  • Physiotherapy
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 57 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    High intensity

    Women who practice sports professionally.

    Other: Educational videos

  • Active comparator
    Low intensity

    Women who practice sport in a non-professional way.

    Other: Educational videos

Interventions

  • OtherEducational videos

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 week (baseline)

  2. 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.

    Time frame: 4 week

Secondary outcomes

  1. 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").

    Time frame: 0 week (pre), 4 week (post)

  2. 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.

    Time frame: 0 week (pre), 4 week (post)

  3. 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.

    Time frame: 0 week (pre), 4 week (post)

  4. Adherence

    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)

  5. 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).

    Time frame: 0 week (pre), 4 week (post)

  6. 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".

    Time frame: 0 week (pre), 4 week (post)

07

Study locations

1 site
  • Faculty of Physiotherapy of the University of Valencia
    Valencia, 46010, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05667012
Lead sponsor
University of Valencia
Responsible party
David Hernández-Guillén (Assistant professor, PT, PhD, University of Valencia) — Principal investigator
First posted
Dec 28, 2022
Start date
Jan 2, 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2024
Last update
Dec 6, 2024

Study contacts

David Hernández Guillén, PT, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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