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Clinical Trials/NCT02318251
NCT02318251UnknownNot Applicable

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

Bern University of Applied Sciences1 site in 1 country96 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.)

Arms & Interventions

Involuntary muscle contractions

Experimental

Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)

Intervention: Involuntary muscle contractions (Other)

Voluntary muscle contractions

Active Comparator

Physiotherapy program (focus on voluntary pelvic floor muscle contractions)

Intervention: Voluntary muscle contractions (Other)

Outcomes

Primary Outcomes

International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))

Time Frame: up to 6 months follow up

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

Secondary Outcomes

  • International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)(up to 6 months follow up)
  • International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))(At the 6 months follow up)
  • Pelvic floor muscle electromyography(up to 6 months follow up)
  • 20-minute PAD-test(up to 6 months follow up)

Investigators

Sponsor
Bern University of Applied Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lorenz Radlinger

Prof. Dr. Lorenz Radlinger

Bern University of Applied Sciences

Study Sites (1)

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