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

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676700
• Other study ID #: H-2-2013-125
• Status: Completed
• Phase: N/A
• First received: January 31, 2016
• Last updated: February 20, 2018
• Start date: February 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: February 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ICIQ-SF	Subjective measure of severity of urinary loss and impact on quality of life	6 weeks
Secondary	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
Secondary	PGI-I (Patient Global Index of Improvement scale)	Global scale	6 and 12 weeks
Secondary	Three days bladder diary	Diary to report number of incontinence episodes	6 and 12 weeks
Secondary	VAS (Visual Analog Scale)	Scale used to report bother with performing the interventions	6 and 12 weeks