Stress Urinary Incontinence Physiotherapy
Primary Purpose
Urinary Incontinence, Stress
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Involuntary muscle contractions
Voluntary muscle contractions
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Power, rate of force development, involuntary, reflexive
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.)
Sites / Locations
- University Hospital, Inselspital, Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Involuntary muscle contractions
Voluntary muscle contractions
Arm Description
Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)
Physiotherapy program (focus on voluntary pelvic floor muscle contractions)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
20-minute PAD-test
The 20 min Pad Test assesses urine loss and leakage volume of the participant
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
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
See primary outcome
Full Information
NCT ID
NCT02318251
First Posted
December 4, 2014
Last Updated
February 7, 2018
Sponsor
Bern University of Applied Sciences
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02318251
Brief Title
Stress Urinary Incontinence Physiotherapy
Official Title
Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bern University of Applied Sciences
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
Power, rate of force development, involuntary, reflexive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Involuntary muscle contractions
Arm Type
Experimental
Arm Description
Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)
Arm Title
Voluntary muscle contractions
Arm Type
Active Comparator
Arm Description
Physiotherapy program (focus on voluntary pelvic floor muscle contractions)
Intervention Type
Other
Intervention Name(s)
Involuntary muscle contractions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Voluntary muscle contractions
Intervention Description
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).
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Description
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
Time Frame
up to 6 months follow up
Secondary Outcome Measure Information:
Title
Pelvic floor muscle electromyography
Description
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)
Time Frame
up to 6 months follow up
Title
20-minute PAD-test
Description
The 20 min Pad Test assesses urine loss and leakage volume of the participant
Time Frame
up to 6 months follow up
Title
International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Description
The ICIQ-LUTSqol questionnaire evaluates the impact the participant's quality of life, with reference also to social effects
Time Frame
up to 6 months follow up
Title
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Description
See primary outcome
Time Frame
At the 6 months follow up
Other Pre-specified Outcome Measures:
Title
Pelvic floor manual muscle testing
Description
Pelvic floor muscle strength will be digitally assessed by the Oxford grading scale.
Time Frame
up to 6 months follow up
Title
Home exercise adherence
Description
Adherence to the home exercise program will be assessed, i.e. how many of the total of therapy sessions will be completed individually
Time Frame
up to 6 months follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Radlinger, Prof. Dr.
Organizational Affiliation
Bern University of Applied Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kuhn Annette, PD Dr. med.
Organizational Affiliation
University Hospital Inselspital, Bern
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital, Inselspital, Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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19941278
Citation
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Stress Urinary Incontinence Physiotherapy
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