Quality and Behavior of Pelvic Floor in Runner Women

Stress Urinary Incontinence Clinical Trial

Official title:

Quality and Behavior of Pelvic Floor in Runner Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03934996
• Other study ID #: corredorasSP
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race.

Description:

Introduction: Women are more likely to suffer injuries in the Pelvic Floor (PF) and Urinary Incontinence (UI) because of their anatomical characteristics. Their participation in the sports field has been more active recently. There are studies that correlate the race with presenting weakness of the SP muscles and Stress Urinary Incontinence (SUI), so the race is considers as a risk factor for these affectations. However, there are few studies of real-time measurements during running. Some runners may even present SUI during daily activities (ADL). The UI is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity.

Objectives: The purpose of this study is to perform measurements of different variables in real time while running and in their ADL. The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. The secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of PF and abdominal girdle (AG) according to the type of stroke, duration, intensity and distance. And compare results between both group (interventional group and no interventional group).

Material and method: Randomized clinical trial will be performed with 59 female runners aged 25-44 years. The sample will be divided into two groups randomly. The study will be carried out health center called "Tiro de Pichón" in Málaga.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 44 Years

Eligibility

Inclusion Criteria:

• Healthy woman between 25 and 44 years old.

• Women not pregnant.

• Women who run at least 10 km / week.

• In case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding.

Exclusion Criteria:

• Women Pregnant or suspected of it.

• Postpartum less than one year.

• Having the period during the exploration for the classification in groups or during the day of the measurements.

• Present operation in the urogenital region as well as any visceral or spinal operation.

• Urinary tract and/or vaginal infections.

• Vaginal lesions; anorectal lesions or bleeding.

• Women with gynecological bleeding; urethral obstruction; fistulas; malformations (ectopic ureter, etc); genital prolapse.

• Women with pain in Pelvic Floor or lower limbs or back.

• Pain during the race.

• Allergy to silver, nickel and/or latex.

Related Conditions & MeSH terms

• Athletic Injuries
• Pelvic Floor Disorders
• Sport Injury
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Runners with educational training
Intervention will consist of an educational talk to know the anatomy and function of the Pelvic Floor Muscles and 20 minutes of both strength and endurance exercises with biofeedback. An exercise protocol will be carried out. The participants will be instruct to contract and maintain maximum force for a mean period of 6 seconds (endurance training) and rest for twice the length of the endurance training time, followed by three fast contractions in a row as strength training. It will be done twice a week, during 12 weeks. Pelvic floor assesment: Perineometry, manual palpation, electromyography Trunk and lower limbs electromyography and kinematics

Locations

Country	Name	City	State
Spain	University of Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004. — View Citation

Carvalhais A, Da Roza T, Vilela S, Jorge RN, Bo K. Association Between Physical Activity Level and Pelvic Floor Muscle Variables in Women. Int J Sports Med. 2018 Dec;39(13):995-1000. doi: 10.1055/a-0596-7531. Epub 2018 Oct 16. — View Citation

Chevalier F, Fernandez-Lao C, Cuesta-Vargas AI. Normal reference values of strength in pelvic floor muscle of women: a descriptive and inferential study. BMC Womens Health. 2014 Nov 25;14:143. doi: 10.1186/s12905-014-0143-4. — View Citation

Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18. — View Citation

Hagovska M, Svihra J, Bukova A, Horbacz A, Drackova D, Svihrova V, Kraus L. Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises. Int J Sports Med. 2017 Mar;38(3):210-216. doi: 10.1055/s-0042-123045. Epub 2017 Feb 17. Erratum In: Int J Sports Med. 2017 Mar;38(3):e1. — View Citation

Leitner M, Moser H, Eichelberger P, Kuhn A, Radlinger L. Evaluation of pelvic floor muscle activity during running in continent and incontinent women: An exploratory study. Neurourol Urodyn. 2017 Aug;36(6):1570-1576. doi: 10.1002/nau.23151. Epub 2016 Oct 29. — View Citation

Luginbuehl H, Naeff R, Zahnd A, Baeyens JP, Kuhn A, Radlinger L. Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study. Arch Gynecol Obstet. 2016 Jan;293(1):117-124. doi: 10.1007/s00404-015-3816-9. Epub 2015 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change %MVC	Change % of Maximun voluntary contraction	Prior and after intervention, an average of 12 weeks
Primary	Change of Base Tone of Pelvic Floor Muscles (EMG)	Electromyography of base tone of Pelvic Floor Muscles	baseline, prior and after intervention, an average of 12 weeks
Primary	Change of step length	Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.	Prior and after intervention, an average of 12 weeks
Primary	Change of cadence	steps/secons. It will measure with two cinematic shimmers wich will be placed on both tibias.It will measure with a cinematic shimmer wich will be placed on both tibias.	Prior and after intervention, an average of 12 weeks
Primary	Change of ground reaction force	Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.	Prior and after intervention, an average of 12 weeks
Primary	Change of acceleration	Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.	Prior and after intervention, an average of 12 weeks
Primary	Change of displacement	metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.	Prior and after intervention, an average of 12 weeks
Primary	Change of accumulated fatigue	Using Lactate Pro 2. Mmol/Litres	Prior and after intervention, an average of 12 weeks
Primary	Change of heart rate	Heart Rate	Prior and after intervention, an average 12 weeks
Primary	Perineometry of MCV	perineometry of MCV using PFX	baseline, prior and after intervention, an average of 12 weeks
Primary	Intravaginal manual palpation	manual testing of the levator ani muscles using scale of Daniels	baseline, prior and after intervention, an average of 12 weeks
Primary	Change of electromyography of Pelvic Floor Muscles	Change of electromyography of Pelvic Floor Muscles	Prior and after intervention, an average of 12 weeks
Secondary	Change Pelvic floor functional capacity	Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)	Prior and after intervention, an average of 12 weeks
Secondary	Quality of life score	Using SF-12 health survey scoring demonstration. It provides a profile of the state of health and is one of the most commonly used generic scales in the evaluation of clinical outcomes. It is a self-administered instrument of 12 items from the 8 dimensions of the SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1) ), Corporal Pain (1), General Health (1). For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health). Validated by Ware J Jr, Kosinki M, Meller SD. and the Spanish version by Vilagut et al., 2008, who obtained an internal consistency coefficient of about 0.9 for Sf-36 and lower light for SF-12. The Cronbach alpha coefficients of the summary components of the SF-12 exceeded the proposed minimum of 0.7 for group comparisons.	Prior and after intervention, an average of 12 weeks