Clinical trial NCT02676700: Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence
Official title: The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: Urinary stress incontinence
pelvic floor muscle
Kaatsu training
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )
timeFrame: 12 weeks
Secondary outcomes:
measure: ICIQ-SF
timeFrame: 6 weeks
measure: UPR (Urethral Pressure Reflectometry)
timeFrame: 12 weeks
measure: PGI-I (Patient Global Index of Improvement scale)
timeFrame: 6 and 12 weeks
measure: Three days bladder diary
timeFrame: 6 and 12 weeks
measure: VAS (Visual Analog Scale)
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Study officials:
affiliation: Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
name: Ulla Due, PT, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
name: Soren Gräs, MD
role: STUDY_DIRECTOR
affiliation: Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
name: Niels Klarskov, MD, lecturer
role: STUDY_DIRECTOR
affiliation: Herlev-Gentofte hospital
name: Anders Vinther, PT, Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
name: Gunnar Lose, MD, Prof
role: STUDY_DIRECTOR
References:
citation: 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.