Clinical trial NCT02318251: Stress Urinary Incontinence Physiotherapy
Official title: Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: Power, rate of force development
involuntary
reflexive
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2014-12-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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.)

Primary outcomes:
measure: International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
timeFrame: up to 6 months follow up
Secondary outcomes:
measure: Pelvic floor muscle electromyography
timeFrame: up to 6 months follow up
measure: 20-minute PAD-test
timeFrame: up to 6 months follow up
measure: International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
timeFrame: up to 6 months follow up
measure: International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
timeFrame: At the 6 months follow up
Other outcomes:
measure: Pelvic floor manual muscle testing
timeFrame: up to 6 months follow up
measure: Home exercise adherence
timeFrame: up to 6 months follow up
Locations:
city: Bern
country: Switzerland
facility: University Hospital, Inselspital, Bern
Study officials:
affiliation: Bern University of Applied Sciences
name: Lorenz Radlinger, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Kuhn Annette, PD Dr. med.
role: STUDY_DIRECTOR
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