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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02676700
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ulla Due, 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.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Behavioral: Pelvic floor muscle training and Kaatsu Behavioral: Pelvic floor muscle training Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence
Study Start Date : February 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676700


Locations
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Denmark
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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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:
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Responsible Party: Ulla Due, Physiotherapist, M.Sc, Ph.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT02676700    
Other Study ID Numbers: H-2-2013-125
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ulla Due, Herlev Hospital:
Urinary stress incontinence
pelvic floor muscle
Kaatsu training
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders