Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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This study examines the effect of adding so called Kaatsu training to pelvic floor muscle training. Half the participants will perform Kaatsu training on their thigh muscles followed by pelvic floor muscle training. The other half will receive pelvic floor muscle training alone.

Detailed Description
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Stress urinary incontinence (SU) is a common problem among adult women . Pelvic floor muscle training (PFMT) is recommended as first line treatment but PFMT is not always efficient and some women cannot comply with the intensive PFMT needed to obtain effect because of weakened or damaged muscles caused by vaginal delivery and age related changes. Hypothetically alternative methods could be used to enhance the effect of a strength-training program. A low intensity training program with a simultaneous partial occlusion of the blood supply for the training muscle, so called Kaatsu training has been found to increase muscle strength faster than ordinary strength training but with much less effort. It seems difficult to make occlusion of the pelvic floor muscles during PFMT but a study found that low intensity training of the quadriceps femoris with partial occlusion of the blood supply did not only increase muscle strength of the quadriceps femoris muscle but also of the biceps humeri muscle if that muscle was trained with low-load training and no occlusion in the same training session. The specific reason for this this cross-transfer effect could not be fully explained but it was believed to be caused by a systemic effect caused by growth hormones. The aim of this study is therefore to examine if Kaatsu training offered in relation to a low-load PFMT program can increase the effect of PFMT in women with SUI

Official Title
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The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training and Kaatsu
* Behavioral: Pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICIQ-SF ≥ 12 Urinary stress incontinence Ability to contract pelvic floor muscles Normal bladder capacity and normal flow during micturition with at least one micturition of > 350 ml Exclusion Criteria: Urgency urinary incontinence Cognitive problems Physical inability to perform Kaatsu program Inability to understand and read Danish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic floor muscle training and Kaatsu<br>Participants are instructed in the PFMT program by primary investigator and instructed in Kaatsu training by a research nurse. The Kaatsu training is performed 4 times a week before PFMT. The program includes 2 x 15 knee extensions with partly occlusion of the blood supply to the thigh. Training level is >12 RM. Training is performed sitting on a chair and rubber bands are used to increase resistance. Training adherence and bother with the training is reported in a training diary. At week 6 the research nurse adjusts the training program. The PFMT program includes three sets of 10 contractions with an intensity of >12 RM and is to be performed 4 times a week. Training adherence and any bother with the training is reported in a training diary. | Behavioral: Pelvic floor muscle training and Kaatsu<br>* The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training<br>|
| Active Comparator: pelvic floor muscle training<br>Participants perform the same PFMT program as the intervention group. The PFMT program includes three sets of 10 contractions with an intensity of >12 RM and is to be performed 4 times a week. Training adherence and any bother with the training is reported in a training diary. | Behavioral: Pelvic floor muscle training<br>* The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form ) | Subjective measure of severity of urinary loss and impact on quality of life | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICIQ-SF | Subjective measure of severity of urinary loss and impact on quality of life | 6 weeks | 
| UPR (Urethral Pressure Reflectometry) | UPR is a novel method measuring the pressure and the cross-sectional area of the female urethra. The difference in urethral opening pressure during pelvic floor muscle contraction before and after intervention is measured in cm H2O | 12 weeks | 
| PGI-I (Patient Global Index of Improvement scale) | Global scale | 6 and 12 weeks | 
| Three days bladder diary | Diary to report number of incontinence episodes | 6 and 12 weeks | 
| VAS (Visual Analog Scale) | Scale used to report bother with performing the interventions | 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary stress incontinence, pelvic floor muscle, Kaatsu training