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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Behavioral: Pelvic floor muscle training and Kaatsu; Behavioral: Pelvic floor muscle training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pelvic floor muscle training and Kaatsu; 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; The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training
ACTIVE_COMPARATOR: pelvic floor muscle training; 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; The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Ulla Due, PT, Ph.D, Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital; Study Director: Soren Gräs, MD, Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital; Study Director: Niels Klarskov, MD, lecturer, Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital; Study Director: Anders Vinther, PT, Ph.D., Herlev-Gentofte Hospital; Study Director: Gunnar Lose, MD, Prof, Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Publications and helpful links

General Publications

• Madarame H, Neya M, Ochi E, Nakazato K, Sato Y, Ishii N. Cross-transfer effects of resistance training with blood flow restriction. Med Sci Sports Exerc. 2008 Feb;40(2):258-63. doi: 10.1249/mss.0b013e31815c6d7e.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (ESTIMATE): February 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pelvic floor muscle; Urinary stress incontinence; Kaatsu training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: H-2-2013-125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO