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

Not Applicable

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Behavioral: Pelvic floor muscle training; Behavioral: Pelvic floor muscle training and Kaatsu

• Registration Number: NCT02676700
• Lead Sponsor: Herlev Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-01-31
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Primary Completion: 2017-07-01
• Study Completion: 2017-08-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pelvic floor muscle training	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.
Pelvic floor muscle training and Kaatsu	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.

Primary Outcome Measures

Name	Time	Method
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )	12 weeks	Subjective measure of severity of urinary loss and impact on quality of life

Secondary Outcome Measures

Name	Time	Method
PGI-I (Patient Global Index of Improvement scale)	6 and 12 weeks	Global scale
ICIQ-SF	6 weeks	Subjective measure of severity of urinary loss and impact on quality of life
UPR (Urethral Pressure Reflectometry)	12 weeks	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
Three days bladder diary	6 and 12 weeks	Diary to report number of incontinence episodes
VAS (Visual Analog Scale)	6 and 12 weeks	Scale used to report bother with performing the interventions

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital; 🇩🇰 Herlev, Denmark