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Pelvic Floor Muscle Training in Gymnasts With Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT04122898
Recruitment Status : Terminated (Due to covid-19)
First Posted : October 10, 2019
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Kari Bø, Norwegian School of Sport Sciences

Brief Summary:

There is a high prevalence of urinary incontinence (UI) among female athletes participating in high impact sports, such as artistic gymnastics, trampoline jumping and ball games. UI is defined as "the complaint of involuntary loss of urine". Stress urinary incontinence (SUI) is the most common type of UI and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or or sneezing or coughing". Urinary leakage during sport activities may affect the athletes' performance, cause bother, frustration and embarrassment and furthermore lead to avoidance and cessation of sport activities. Pelvic floor muscle (PFM) training is highly effective in treating SUI in the general female population. However, evidence of the effect of PFM training in elite athletes in high impact sports is sparse.

The purpose of this assessor-blinded randomized controlled trial (RCT) is to assess the effect of PFM training on symptoms, bother and amount of SUI in female artistic gymnasts, team gymnasts and cheerleaders.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Stress Urinary Incontinence Other: Pelvic Floor Muscle Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pelvic Floor Muscles Training on Symptoms, Bother and Amount of Stress Urinary Incontinence in Female Gymnasts, Team Gymnasts and Cheerleaders. An Assessor Blinded Randomized Controlled Trial
Actual Study Start Date : January 20, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Three months home-based PFM training program with weekly follow-up by a physiotherapist
Other: Pelvic Floor Muscle Training
The intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the gymnasts in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (inward lift of the pelvic floor assessed with suprapubic 2D ultrasound) and instructions on how to perform the training program. The athletes will be offered at least one individual follow-up session with the same physiotherapist during the intervention period. The program will consist of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The athletes will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 3 months and the exercises will take approximately 10 minutes per day to perform.
Other Name: Pelvic Floor Muscle Training in Elite Gymnasts

No Intervention: Control Group
No intervention



Primary Outcome Measures :
  1. Pad-weight Stress Test for Stress Urinary Incontinence [ Time Frame: Change from baseline pad-test at three months ]
    The test will be modified from the descriptions by Mørkved & Bø, Eliasson, Larsson & Mattson and Ferreira et al. The athletes will be requested to void 30 minutes before the test, to drink 0.5 liter of water and thereafter not empty their bladder. A pre-weighted pad will be applied, and the athletes will perform a 10 minutes intensive warm-up followed by 5 minutes of high impact gymnast- or cheerleading routines.


Secondary Outcome Measures :
  1. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) [ Time Frame: Change in total score from baseline at three months ]
    A reliable and valid questionnaire assessing self-reported prevalence, amount of leakage, bother and type of UI. A change in ICIQ-UI-SF score of 1.58 points will be considered as between-treatment minimum important difference.

  2. Patient Global Impression of Improvement (PGI-I) Scale [ Time Frame: Post-test after a 3-months intervention period ]
    The gymnasts will be asked to rate their perceived change of the condition. A validated 7-point scale with response choices ranging from "very much better" to "very much worse" will be used.

  3. Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE) [ Time Frame: At baseline in both groups. Athletes in the intervention group will also be asked to answer the questionnaire again within the first month of the intervention period. ]
    The gymnasts will be asked to rate their self-efficacy (from 0-100) on 16 different items regarding PFM training. The scale have been tested to have good internal consistency (α = 0.92) and acceptable reliability (rho = 0.89).



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female artistic gymnasts, team gymnasts and cheerleaders
  • competed in the Norwegian National Championship in 2018 and/or 2019 or competitions of higher levels
  • > 12 years of age
  • total score on ICIQ-UI-SF of >3
  • positive pad weight-test: >1 gram of leakage
  • self-reported SUI with ICIQ-UI-SF (urinary leakage during physical activity, exercise, sneezing or coughing)

Exclusion Criteria:

  • history of pregnancy, pelvic surgery, pelvic trauma, inflammatory bowel diseases or respiratory diseases/symptoms
  • male gymnasts
  • < 12 years of age
  • not competed in the Norwegian National Championship in 2018 and/or 2019 or competitions of higher levels
  • athletes who are unable to correctly contract the PFM, examined by suprapubic transabdominal 2D ultrasound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122898


Locations
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Norway
Norwegian School of Sport Sciences, Department of Sport Medicine
Oslo, Norway, 0863
Sponsors and Collaborators
Norwegian School of Sport Sciences
Investigators
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Study Chair: Kari Bø, PhD Norwegian School of School of Sport Sciences
Publications:
Ruiz-Zapata, A. M., Feola, A. J., Heesakkers, J., de Graaf, P., Blaganje, M., & Sievert, K. D. (2018). Biomechanical Properties of the Pelvic Floor and its Relation to Pelvic Floor Disorders. European Urology Supplements, 17(3), 80-90.
Milsom, I., Altman, D., Cartwright, R., Lapitan, M. C. M., Nelson, R., Sjöström, S., & Tikkinen, K. A. O. (2017). Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. In P. C. Abrams, L.; Wagg, A.; Wein, A. (Ed.), Incontinence (Vol. 1, pp. 1-141). Tokyo: 6th International Consultation on Incontinence.
Bø, K. (2015). Pelvic floor dysfunction, prevention and treatment in elite athletes. In K. Bø, B. Berghmans, S. Mørkved, & M. Van Kampen (Eds.), Evidence based Physical Therapy for the Pelvic Floor - Bridging science and clinical practice (pp. 397-407). Edinburgh London New York Oxford Philadelphia St Louis Sydney Toronto: Elsevier Churchilll Livingstone.
Carls, C. (2006). The prevalence of stress urinary incontinence in high school- and college-age female athletes in the midwest: Evidence of stigma and implications for education and prevention. Journal of Wound Ostomy and Continence Nursing, 33(3), S40-S41.
Ferreira, S., Ferreira, M., Carvalhais, A., Santos, P. C., Rocha, P., & Brochado, G. (2014). Reeducation of pelvic floor muscles in volleyball athletes. Rev Assoc Med Bras, 60(5), 428-433.

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Responsible Party: Kari Bø, Professor, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT04122898    
Other Study ID Numbers: KLS2019
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders