Stress Urinary Incontinence Physiotherapy

Urinary Incontinence, Stress Clinical Trial

Official title:

Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02318251
• Other study ID #: SUIP
• Status: Active, not recruiting
• Phase: N/A
• First received: December 4, 2014
• Last updated: February 7, 2018
• Start date: January 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2018
• Source: Bern University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence.

Description:

Stress urinary incontinence (SUI), the most prevalent type of urinary incontinence, is defined as involuntary loss of urine during effort, or physical exertion (e.g. sporting activities), or upon sneezing, or coughing (Haylen et al, 2010). The overall prevalence of stress, urge, mixed, and any UI was 23.7%, 9.9%, 14.5%, and 49.2%, respectively (Minassian et al, 2008).

Numerous epidemiologic studies show that parity is a risk factor for SUI. Other significant risk factors are age, weight, obesity, chronic pulmonary diseases, ethnic background, and menopause. (Minassian et al, 2008; Matthews et al, 2013) Urinary incontinence affects four times more women (51.1%) than men (13.9%) (Markland et al, 2011). It has an impact on the physical, psychosocial, social, personal, and economic well-being of the affected individuals and of their families. It is associated with a concomitant impairment of activities and participation, and a higher risk of suffering from anxiety disorders has been shown. (Goldstick & Constantini, 2014; Hunskaar et al, 2003).

SUI is increasingly recognized as a health and economic problem, which not only troubles the affected women, but also implies a substantial economic burden on the health and social services (Hampel et al, 2004).

Consequently, as physiotherapy has proven to be good value for the money, its effectiveness could contribute to a reduction in the cost of health care.

Pelvic floor muscles (PFM) have to be able to contract strongly (Shishido et al, 2008), rapidly and reflexively (Deffieux et al; 2008; Morin et al, 2004) to guarantee continence. The ability of PFM to generate rapid and strong contractions results in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage (Miller et al, 1994). Rapid and reflexive PFM contractions are crucial for maintaining continence, preceding an abrupt rise in the intra-abdominal pressure associated with coughing, sneezing, running, or jumping (Morin et al., 2004). Studies have shown that the PFM function regarding power (rate of force development) was impaired in incontinent women compared to continent women (Deffieux et al, 2008; Morin et al, 2004).

PFM training - defined as a program of repeated voluntary PFM contractions taught and supervised by a health care professional - is the most commonly used physiotherapy treatment for women with SUI and is effective in the treatment of female stress and mixed urinary incontinence and, therefore, is recommended as a first-line therapy (Dumoulin et al, 2014; Bø, 2012). As recommended by the International Consultation on Incontinence (ICI) PFM training should generally be the first step of treatment before surgery (Abrams et al, 2010). However, standard SUI physiotherapy concentrates on voluntary contractions even though the situations provoking SUI such as sneezing, coughing, jumping and running (Haylen et al, 2010) require involuntary fast reflexive pelvic floor muscle contractions. Although training procedures following the concepts of training science and sports medicine are generally well known and widely implemented in rehabilitation and sports (ACSM, 2009; Schmidtbleicher & Gollhofer, 1991), the optimal, and well standardized training protocol for involuntary, fast, and reflexive PFM contractions still remains unknown.

Consequently, the research group developed a standardized therapy program, which includes the standard therapy and additionally focuses on involuntary fast reflexive PFM contractions. The additional exercises are well known and applied in physiotherapy, however not yet regarding SUI.

Therefore, the aim of the present study is to compare two different physiotherapy programs for women suffering from SUI. Both programs include standard physiotherapy. Both follow the concepts of training science (periodization/ exercise sequence and training of specific muscle strength components). One program focuses on voluntary fast contractions (standard physiotherapy; control group), the other one focuses on involuntary fast reflexive PFM contractions (experimental group).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature

• Stress urinary incontinence (based on the patient's history)

• Mixed incontinence (with dominant SUI)

• 1 year post-partal, parous, nulliparous, pre- or post-menopausal

• BMI 18-30

• Participants must be medically and physically fit for the exercises (running, jumps)

• Stable on systemic or local estrogen treatment for the past 3 months prior to inclusion

Exclusion Criteria:

• Urge incontinence or predominant urgency in incontinence

• Prolapse > grade 1 POP-Q (Bump et al., 1996) (uterus, cystocele, rectocele during Valsalva maneuver)

• Pregnancy (test to accomplish)

• Current urinary tract or vaginal infection

• Menstruation on the day of examination

• Lactation period not yet finished

• Contraindications for measurements, e.g. acute inflammatory or infectious disease, tumor, fracture

• De novo systemic or local estrogen treatment (< 3 months)

• De novo drug treatment with anticholinergics or other bladder active substances (tricyclic antidepressants, Selective Serotonin Reuptake Inhibitor etc.)

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Involuntary muscle contractions
Physiotherapy program focusing on involuntary pelvic floor muscle fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day). This program includes the standard physiotherapy.
• Voluntary muscle contractions
Physiotherapy program (physiotherapy standard program) focusing on voluntary fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day).

Locations

Country	Name	City	State
Switzerland	University Hospital, Inselspital, Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Bern University of Applied Sciences	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

Abrams P, Avery K, Gardener N, Donovan J; ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006 Mar;175(3 Pt 1):1063-6; discussion 1066. — View Citation

American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670. Review. — View Citation

Bø K. Pelvic floor muscle training in treatment of female stress urinary incontinence, pelvic organ prolapse and sexual dysfunction. World J Urol. 2012 Aug;30(4):437-43. doi: 10.1007/s00345-011-0779-8. Epub 2011 Oct 9. Review. — View Citation

Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. — View Citation

Dumoulin C, Hay-Smith EJ, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3. Review. — 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. Review. — View Citation

Hampel C, Artibani W, Espuña Pons M, Haab F, Jackson S, Romero J, Gavart S, Papanicolaou S. Understanding the burden of stress urinary incontinence in Europe: a qualitative review of the literature. Eur Urol. 2004 Jul;46(1):15-27. Review. — 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; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. Review. — View Citation

Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjälmås K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003 Oct;62(4 Suppl 1):16-23. Review. — View Citation

Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114. — View Citation

Matthews CA, Whitehead WE, Townsend MK, Grodstein F. Risk factors for urinary, fecal, or dual incontinence in the Nurses' Health Study. Obstet Gynecol. 2013 Sep;122(3):539-45. doi: 10.1097/AOG.0b013e31829efbff. — View Citation

Miller J, Kasper C, Sampselle C. Review of muscle physiology with application to pelvic muscle exercise. Urol Nurs. 1994 Sep;14(3):92-7. — View Citation

Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17. — View Citation

Morin M, Bourbonnais D, Gravel D, Dumoulin C, Lemieux MC. Pelvic floor muscle function in continent and stress urinary incontinent women using dynamometric measurements. Neurourol Urodyn. 2004;23(7):668-74. — View Citation

Schmidtbleicher D, Gollhofer A. [Specific methods of strength training also in rehabilitation]. Sportverletz Sportschaden. 1991 Sep;5(3):135-41. Review. German. — View Citation

Shishido K, Peng Q, Jones R, Omata S, Constantinou CE. Influence of pelvic floor muscle contraction on the profile of vaginal closure pressure in continent and stress urinary incontinent women. J Urol. 2008 May;179(5):1917-22. doi: 10.1016/j.juro.2008.01.020. Epub 2008 Mar 18. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pelvic floor manual muscle testing	Pelvic floor muscle strength will be digitally assessed by the Oxford grading scale.	up to 6 months follow up
Other	Home exercise adherence	Adherence to the home exercise program will be assessed, i.e. how many of the total of therapy sessions will be completed individually	up to 6 months follow up
Primary	International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))	The ICIQ-UIsf provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment	up to 6 months follow up
Secondary	Pelvic floor muscle electromyography	Electromyography (EMG) activity measurements during rest, during maximal Voluntary contraction, fast voluntary contractions and during involuntary contractions (squat jumps, counter movement jumps, drop jumps), and during running at 7,9,11 km/h)	up to 6 months follow up
Secondary	20-minute PAD-test	The 20 min Pad Test assesses urine loss and leakage volume of the participant	up to 6 months follow up
Secondary	International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)	The ICIQ-LUTSqol questionnaire evaluates the impact the participant's quality of life, with reference also to social effects	up to 6 months follow up
Secondary	International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))	See primary outcome	At the 6 months follow up