Pelvic Floor Muscle Training in Gymnasts With Stress Urinary Incontinence

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04122898
• Other study ID #: KLS2019
• Status: Terminated
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: August 19, 2020

Study information

• Verified date: April 2022
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND:

Physical activity and exercise have well-known beneficial effects on several physical and psychological health outcomes. However, it has been proposed that regular participation in physical activity and exercise may lead to greater risk of developing pelvic floor dysfunctions (PFD) in women. The pelvic floor consists of muscles, fascia and ligaments and forms a hammock-like support at the base of the abdomino-pelvic cavity. The function of the pelvic floor is to provide support to the pelvic organs (the bladder, urethra, vagina, uterus and rectum) and to counteract all increases in intra-abdominal pressure and ground reactions forces during daily activities. Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic floor can lead to urinary and anal incontinence, pelvic organ prolapse, sexual problems and chronic pain syndromes. UI is the most common PFD, defined as "the complaint of involuntary loss of urine". SUI, urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) are common subtypes of UI. In women, SUI accounts for approximately half of all incontinence types and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or on sneezing or coughing". UUI is defined as the "complaint of involuntary loss of urine associated with urgency" and MUI as "complaints of both stress and urgency urinary incontinence".

High prevalence rates of UI among both parous and nulliparous female athletes and exercisers have been reported in several cross-sectional studies. The prevalence rates varies between 0-80% with the highest prevalence found in high impact sports such as trampoline jumping, gymnastics and ball games. Leakage during sport activities may affect the athletes' performance and cause bother, frustration and embarrassment. Some athletes have reported that UI issues have also led to avoidance or cessation of sport or exercise.

To date, there is level 1 evidence and grade A recommendation for PFM training alone to be first line treatment for SUI, MUI and pelvic organ prolapse in the general female population. In addition, PFM training is highly effective as primary prevention; pregnant continent women who exercise the PFM are at 62% less risk of UI in late pregnancy and 29% less risk of UI 3-6 months postpartum. Evidence of the effect of PFM training in athletes or strenuous exercisers is sparse.

In one study on female soldiers and two small case series in female athletes and exercisers, PFM training led to reduced symptoms of UI. However, none of these studies included a non-treated control group and the internal validity is therefore low. To our knowledge, only one RCT has assessed effects of PFM training on SUI in athletes. Female volleyball players (n=16) who followed a PFM training program had significant improvements of SUI compared to a control group (n=16).

Based on today's knowledge we do not know whether PFM training is effective in elite athletes exposed to excessive impact in sports including elements of acrobatics and jumping. Given the high impact on the pelvic floor in these athletes, it is presumed that they need much better pelvic floor muscle function than non-exercisers. On the other hand, elite athletes are highly motivated for regular training. Strength training of the PFM, if proven effective, may be easily incorporated in their basic training regimens both as prevention and treatment strategies of SUI.

AIMS:

The aim of this RCT is to assess the effect of PFM training on symptoms, bother and amount of SUI among female artistic gymnasts, team gymnasts and cheerleaders.

STUDY DESIGN AND METHODS:

A cross-sectional study will be conducted to assess prevalence of SUI among female artistic gymnasts, team gymnasts and cheerleaders from 12 years of age competing on high national levels in Norway. Athletes reporting symptoms of SUI will be asked to participate in the RCT.

The study is an assessor-blinded RCT evaluating the effect of PFM training on SUI in elite female gymnasts, team gymnasts and cheerleaders. At baseline, all athletes will perform a pad weight-test, measuring the amount of leakage during gymnastic and acrobatic activities. In addition, the athletes will respond to a standardized questionnaire, measuring self-reported symptoms of UI and bother. The athletes will be randomly assigned to either a PFM training group (EG) or a control group (CG) with no intervention. The intervention consists of a daily home-based PFM training program with weekly follow-up by a physiotherapist. After a three-months intervention period, all athletes will perform a post-test including the same previous mentioned outcome measures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• female artistic gymnasts, team gymnasts and cheerleaders

• eligible to compete in the Norwegian National Championship 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 eligible to competed in the Norwegian National Championship or competitions of higher levels

• athletes who are unable to correctly contract the PFM, examined by suprapubic transabdominal 2D ultrasound

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Norwegian School of Sport Sciences, Department of Sport Medicine	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (26)

Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. — View Citation

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.

Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. Review. — View Citation

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.

Da Roza T, Brandão S, Mascarenhas T, Jorge RN, Duarte JA. Volume of training and the ranking level are associated with the leakage of urine in young female trampolinists. Clin J Sport Med. 2015 May;25(3):270-5. doi: 10.1097/JSM.0000000000000129. — View Citation

de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19. — View Citation

Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10:CD005654. doi: 10.1002/14651858.CD005654.pub4. — View Citation

Eliasson K, Edner A, Mattsson E. Urinary incontinence in very young and mostly nulliparous women with a history of regular organised high-impact trampoline training: occurrence and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):687-96. doi: 10.1007/s00192-007-0508-4. Epub 2008 Jan 26. — View Citation

Eliasson K, Larsson T, Mattsson E. Prevalence of stress incontinence in nulliparous elite trampolinists. Scand J Med Sci Sports. 2002 Apr;12(2):106-10. — View Citation

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.

Hagovska M, Ján Š, Buková A, Horbacz A, Dracková D, Švihrová V, Kraus L. Correction: Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises. Int J Sports Med. 2017 Mar;38(3):e1. doi: 10.1055/s-0043-120578. Epub 2018 Jan 22. — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25. Review. — View Citation

Jácome C, Oliveira D, Marques A, Sá-Couto P. Prevalence and impact of urinary incontinence among female athletes. Int J Gynaecol Obstet. 2011 Jul;114(1):60-3. doi: 10.1016/j.ijgo.2011.02.004. Epub 2011 May 14. — View Citation

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.

Mørkved S, Bø K. The effect of postpartum pelvic floor muscle exercise in the prevention and treatment of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1997;8(4):217-22. — View Citation

Nygaard IE, Shaw JM. Physical activity and the pelvic floor. Am J Obstet Gynecol. 2016 Feb;214(2):164-171. doi: 10.1016/j.ajog.2015.08.067. Epub 2015 Sep 6. Review. — View Citation

Nygaard IE, Thompson FL, Svengalis SL, Albright JP. Urinary incontinence in elite nulliparous athletes. Obstet Gynecol. 1994 Aug;84(2):183-7. Erratum in: Obstet Gynecol 1994 Sep;84(3):342. — View Citation

Nyström E, Sjöström M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2015 Nov;34(8):747-51. doi: 10.1002/nau.22657. Epub 2014 Aug 22. — View Citation

Piercy KL, Troiano RP. Physical Activity Guidelines for Americans From the US Department of Health and Human Services. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e005263. doi: 10.1161/CIRCOUTCOMES.118.005263. — View Citation

Poswiata A, Socha T, Opara J. Prevalence of stress urinary incontinence in elite female endurance athletes. J Hum Kinet. 2014 Dec 30;44:91-6. doi: 10.2478/hukin-2014-0114. eCollection 2014 Dec 9. — View Citation

Rivalta M, Sighinolfi MC, Micali S, De Stefani S, Torcasio F, Bianchi G. Urinary incontinence and sport: first and preliminary experience with a combined pelvic floor rehabilitation program in three female athletes. Health Care Women Int. 2010 May;31(5):435-43. doi: 10.1080/07399330903324254. — View Citation

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.

Sacomori C, Cardoso FL, Porto IP, Negri NB. The development and psychometric evaluation of a self-efficacy scale for practicing pelvic floor exercises. Braz J Phys Ther. 2013 Jul-Aug;17(4):336-42. doi: 10.1590/S1413-35552013005000104. Epub 2013 Aug 30. English, Portuguese. — View Citation

Sherman RA, Davis GD, Wong MF. Behavioral treatment of exercise-induced urinary incontinence among female soldiers. Mil Med. 1997 Oct;162(10):690-4. — View Citation

Woodley SJ, Boyle R, Cody JD, Mørkved S, Hay-Smith EJC. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2017 Dec 22;12:CD007471. doi: 10.1002/14651858.CD007471.pub3. Review. Update in: Cochrane Database Syst Rev. 2020 May 6;5:CD007471. — View Citation

Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pad-weight Stress Test for Stress Urinary Incontinence	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.	Change from baseline pad-test at three months
Secondary	The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)	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.	Change in total score from baseline at three months
Secondary	Patient Global Impression of Improvement (PGI-I) Scale	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.	Post-test after a 3-months intervention period
Secondary	Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)	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 (a = 0.92) and acceptable reliability (rho = 0.89).	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.