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Completed

NCT Number: NCT02676700

Pelvic Floor Muscle Training and 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle training and Kaatsu

Behavioral

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

Behavioral

The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training

Primary outcomes

  1. ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )

    Time frame: 12 weeks

    Subjective measure of severity of urinary loss and impact on quality of life

Secondary outcomes

  1. ICIQ-SF

    Time frame: 6 weeks

    Subjective measure of severity of urinary loss and impact on quality of life

  2. UPR (Urethral Pressure Reflectometry)

    Time frame: 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

  3. PGI-I (Patient Global Index of Improvement scale)

    Time frame: 6 and 12 weeks

    Global scale

  4. Three days bladder diary

    Time frame: 6 and 12 weeks

    Diary to report number of incontinence episodes

  5. VAS (Visual Analog Scale)

    Time frame: 6 and 12 weeks

    Scale used to report bother with performing the interventions

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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