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

NCT06224335 | Completed

• 1 other identifier: EC UNM 115/2023
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence; Athletes

Keywords

Stress urinary incontinence; Athletes; Intravaginal pressure; Intra-abdominal pressure

Outcome Measures

Primary Outcomes (1)

• To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.

  Intravaginal and intra-abdominal pressure will be measured in mmHg.

  During the performance of sporting activities up to 60 minutes.

Secondary Outcomes (2)

• To detect the amount of urine leakage by an innovative pad test in sportwoman.

  During the performance of sporting activities up to 60 minutes.

• 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.

Study Arms (2)

sportwoman with high intensity of physical activity with stress urinary incontinence

High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.

Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

sportwoman with high intensity of physical activity without stress urinary incontinence

High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.

Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

Interventions

intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running DIAGNOSTIC_TEST

Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.

Also known as: intravaginal and intra-abdominal pressure with Femfit® device during (squeeeze, knack, rapid contractions, endurance contracions), inovative pad test during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

sportwoman with high intensity of physical activity with stress urinary incontinence; sportwoman with high intensity of physical activity without stress urinary incontinence

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

sportwoman with high intensity of physical activity with and without stress urinary incontinence

You may qualify if:

• nulliparous women
• aged 18-35
• high-intensity physical activity
• performed sport at least three days per week, 90 minutes per day, for more than two years

You may not qualify if:

• 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

Sponsors & Collaborators

• Comenius University: lead
• Pavol Jozef Safarik University: collaborator

Study Sites (1)

Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic

Martin, Slovakia, 03659, Slovakia

Location

Related Publications (2)

• Kruger JA, Dietz HP, Murphy BA. Pelvic floor function in elite nulliparous athletes. Ultrasound Obstet Gynecol. 2007 Jul;30(1):81-5. doi: 10.1002/uog.4027.

  PMID: 17497753 BACKGROUND

• Hagovska M, Bukova A, Svihra J. Measurement of the Vaginal Pressure Profile with the Femfit(R) and Leakage Events Using a Newly Developed Pad Test during Selected Sports Activities: A Pilot Study. Int Urogynecol J. 2025 Apr;36(4):789-797. doi: 10.1007/s00192-025-06051-y. Epub 2025 Jan 21.

  PMID: 39836175 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Magdaléna Hagovská, Dr., PhD

  Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 25, 2024
• Study Start: September 28, 2023
• Primary Completion: February 14, 2024
• Study Completion: March 28, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)