NCT05667012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 14, 2022

Last Update Submit

December 5, 2024

Conditions

Keywords

Educational pillsPreventionSportsPhysiotherapy

Outcome Measures

Primary Outcomes (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.

    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.

    4 week

Secondary Outcomes (6)

  • Motivation

    0 week (pre), 4 week (post)

  • Perception

    0 week (pre), 4 week (post)

  • Quality of life of participants

    0 week (pre), 4 week (post)

  • Adherence

    0 week (pre), 4 week (post)

  • Sexual function

    0 week (pre), 4 week (post)

  • +1 more secondary outcomes

Study Arms (2)

High intensity

EXPERIMENTAL

Women who practice sports professionally.

Other: Educational videos

Low intensity

ACTIVE COMPARATOR

Women who practice sport in a non-professional way.

Other: Educational videos

Interventions

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.

High intensityLow intensity

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy of the University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Hernández Guillén, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator analyzing the results will be blinded to the intervention group to which the participants belong.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, PT, PhD

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 28, 2022

Study Start

January 2, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations