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

NCT ID: NCT02676700

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-08-01

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

Conditions

Urinary Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training and Kaatsu

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ulla Due

Physiotherapist, M.Sc, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulla Due, PT, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Soren Gräs, MD

Role: STUDY_DIRECTOR

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Niels Klarskov, MD, lecturer

Role: STUDY_DIRECTOR

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Anders Vinther, PT, Ph.D.

Role: STUDY_DIRECTOR

Herlev-Gentofte hospital

Gunnar Lose, MD, Prof

Role: STUDY_DIRECTOR

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Locations

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 18202577 (View on PubMed)

Other Identifiers

H-2-2013-125

Identifier Type: -

Identifier Source: org_study_id