Stress Urinary Incontinence Physiotherapy

February 7, 2018 updated by: Lorenz Radlinger, Bern University of Applied Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital, Inselspital, Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Involuntary muscle contractions
Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)
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.
Active Comparator: Voluntary muscle contractions
Physiotherapy program (focus on voluntary pelvic floor muscle contractions)
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor muscle electromyography
Time Frame: up to 6 months follow up
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
20-minute PAD-test
Time Frame: up to 6 months follow up
The 20 min Pad Test assesses urine loss and leakage volume of the participant
up to 6 months follow up
International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time Frame: up to 6 months follow up
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
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Time Frame: At the 6 months follow up
See primary outcome
At the 6 months follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor manual muscle testing
Time Frame: up to 6 months follow up
Pelvic floor muscle strength will be digitally assessed by the Oxford grading scale.
up to 6 months follow up
Home exercise adherence
Time Frame: up to 6 months follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bern University of Applied Sciences

Collaborators

University Hospital Inselspital, Berne

Investigators

  • Study Director: Lorenz Radlinger, Prof. Dr., Bern University of Applied Sciences
  • Study Director: Kuhn Annette, PD Dr. med., University Hospital Inselspital, Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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