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

Stress Urinary Incontinence Clinical Trial

— SPORTVAGPRES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06224335
• Other study ID #: EC UNM 115/2023
• Status: Active, not recruiting
• Start date: September 28, 2023
• Est. completion date: March 28, 2024

Study information

• Verified date: February 2024
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 28, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletes
• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Slovakia	Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic	Martin

Sponsors (2)

Lead Sponsor	Collaborator
Comenius University	Pavol Jozef Safarik University

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.