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

Femfit® and an Innovative Pad Test to Assess Pelvic Floor Muscle Activation During Physical Activity in Sportwoman with and Without SUI - a Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence; Athletes
• Intervention / Treatment: Diagnostic test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia, 03659
    • Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion criteria

• 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

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.; Other Names: 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 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; Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Comenius University
• Collaborators: Pavol Jozef Safarik University
• Investigators: Study Director: Magdaléna Hagovská, Dr., PhD, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Intra-abdominal pressure; Stress urinary incontinence; Athletes; Intravaginal pressure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: EC UNM 115/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No