Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)

Active, not recruiting

• Conditions: Stress Urinary Incontinence; Athletes
• Interventions: Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

• Registration Number: NCT06224335
• Lead Sponsor: Comenius University

Brief Summary

To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.

Detailed Description

This is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.

Study Timeline

• Study Start: 2023-09-28
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-02-14
• Study Completion: 2024-03-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

• handicapped sportswomen
• performance of various kinds of sport
• no regular sport activity
• performance of sports for less than two years
• after childbirth
• surgical treatment of gynaecological and urological illnesses
• urinary tract infection
• disease of respiratory tract
• not sufficiently completed questionnaires
• refusal to participate
• body mass index greater than 30 (BMI = m/h2, where m = body weight in kilograms and h = body height in metres)
• symptoms of overactive bladder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sportwoman with high intensity of physical activity with stress urinary incontinence	intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running	High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.
sportwoman with high intensity of physical activity without stress urinary incontinence	intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running	High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.

Primary Outcome Measures

Name	Time	Method
To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.	During the performance of sporting activities up to 60 minutes.	Intravaginal and intra-abdominal pressure will be measured in mmHg.

Secondary Outcome Measures

Name	Time	Method
To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.	During the performance of sporting activities up to 60 minutes.	Degree of leakage of urine will be measured by the International Consultation on Incontinence Questionnaire short form in score.
To detect the amount of urine leakage by an innovative pad test in sportwoman.	During the performance of sporting activities up to 60 minutes.	Leakage of urine will be measured by weight of pad in grams.

Trial Locations

Locations (1)

Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic; 🇸🇰 Martin, Slovakia