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

Primary Purpose

Urinary Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pelvic floor muscle training and Kaatsu
Pelvic floor muscle training
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Urinary stress incontinence, pelvic floor muscle, Kaatsu training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pelvic floor muscle training and Kaatsu

pelvic floor muscle training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )
Subjective measure of severity of urinary loss and impact on quality of life

Secondary Outcome Measures

ICIQ-SF
Subjective measure of severity of urinary loss and impact on quality of life
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
PGI-I (Patient Global Index of Improvement scale)
Global scale
Three days bladder diary
Diary to report number of incontinence episodes
VAS (Visual Analog Scale)
Scale used to report bother with performing the interventions

Full Information

First Posted
January 31, 2016
Last Updated
February 20, 2018
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02676700
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Urinary stress incontinence, pelvic floor muscle, Kaatsu training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training and Kaatsu
Arm Type
Active Comparator
Arm Description
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.
Arm Title
pelvic floor muscle training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training and Kaatsu
Intervention Description
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
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training
Primary Outcome Measure Information:
Title
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )
Description
Subjective measure of severity of urinary loss and impact on quality of life
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ICIQ-SF
Description
Subjective measure of severity of urinary loss and impact on quality of life
Time Frame
6 weeks
Title
UPR (Urethral Pressure Reflectometry)
Description
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
Time Frame
12 weeks
Title
PGI-I (Patient Global Index of Improvement scale)
Description
Global scale
Time Frame
6 and 12 weeks
Title
Three days bladder diary
Description
Diary to report number of incontinence episodes
Time Frame
6 and 12 weeks
Title
VAS (Visual Analog Scale)
Description
Scale used to report bother with performing the interventions
Time Frame
6 and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Due, PT, Ph.D
Organizational Affiliation
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soren Gräs, MD
Organizational Affiliation
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Niels Klarskov, MD, lecturer
Organizational Affiliation
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anders Vinther, PT, Ph.D.
Organizational Affiliation
Herlev-Gentofte hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gunnar Lose, MD, Prof
Organizational Affiliation
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18202577
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.
Results Reference
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Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence

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