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

NCT02676700 | Completed DMC

• 1 other identifier: H-2-2013-125
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence

Keywords

Urinary stress incontinence; pelvic floor muscle; Kaatsu training

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Secondary Outcomes (5)

• ICIQ-SF

  6 weeks

• UPR (Urethral Pressure Reflectometry)

  12 weeks

• PGI-I (Patient Global Index of Improvement scale)

  6 and 12 weeks

• Three days bladder diary

  6 and 12 weeks

• VAS (Visual Analog Scale)

  6 and 12 weeks

Study Arms (2)

Pelvic floor muscle training and Kaatsu

ACTIVE COMPARATOR

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

pelvic floor muscle training

ACTIVE COMPARATOR

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

Interventions

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 and Kaatsu

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

pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Urgency urinary incontinence
• Cognitive problems
• Physical inability to perform Kaatsu program
• Inability to understand and read Danish

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 18202577 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulla Due, PT, Ph.D

  Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, M.Sc, Ph.D.

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 8, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)