Urinary Stress IncontinenceNCT02676700
Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence
A study testing Pelvic floor muscle training and Kaatsu and Pelvic floor muscle training in people with Urinary Stress Incontinence, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Pelvic floor muscle training and Kaatsu and Pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Urgency urinary incontinence
- Cognitive problems
- Physical inability to perform Kaatsu program
- Inability to understand and read Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Herlev, 2730
About this study
Official title: The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence
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.
Read the 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
- Being tested
- Pelvic floor muscle training and Kaatsu, Pelvic floor muscle training
- Keywords
- Urinary stress incontinence, pelvic floor muscle, Kaatsu training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training and KaatsuBehavioural
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 trainingBehavioural
The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )
Subjective measure of severity of urinary loss and impact on quality of life
Measured: 12 weeks
Secondary outcomes (5)
ICIQ-SF
Subjective measure of severity of urinary loss and impact on quality of life
Measured: 6 weeks
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
Measured: 12 weeks
PGI-I (Patient Global Index of Improvement scale)
Global scale
Measured: 6 and 12 weeks
Three days bladder diary
Diary to report number of incontinence episodes
Measured: 6 and 12 weeks
VAS (Visual Analog Scale)
Scale used to report bother with performing the interventions
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion1 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Due, Herlev Hospital
- Investigators
- Ulla Due, PT, Ph.D, Principal investigator, Department of Gynecology and Obstetrics, Herlev-Gentofte HospitalSoren Gräs, MD, Study director, Department of Gynecology and Obstetrics, Herlev-Gentofte HospitalNiels Klarskov, MD, lecturer, Study director, Department of Gynecology and Obstetrics, Herlev-Gentofte HospitalAnders Vinther, PT, Ph.D., Study director, Herlev-Gentofte hospitalGunnar Lose, MD, Prof, Study director, Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676700
- Sponsor's protocol ID
- H-2-2013-125
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18202577
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02676700
- Acronym / sponsor ID
- H-2-2013-125
- Conditions
- Urinary Stress Incontinence
- Keywords
- Urinary stress incontinence, pelvic floor muscle, Kaatsu training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training and Kaatsu | Active comparator | Behavioral: Pelvic floor muscle training and KaatsuParticipants 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. |
| pelvic floor muscle training | Active comparator | Behavioral: Pelvic floor muscle trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Urgency urinary incontinence
- Cognitive problems
- Physical inability to perform Kaatsu program
- Inability to understand and read Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training and KaatsuThe intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training | Behavioural | Pelvic floor muscle training and Kaatsu |
| Pelvic floor muscle trainingThe intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training | Behavioural | pelvic floor muscle training |
Primary outcome
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
5 secondary outcomes
ICIQ-SF
Time frame: 6 weeks
UPR (Urethral Pressure Reflectometry)
Time frame: 12 weeks
PGI-I (Patient Global Index of Improvement scale)
Time frame: 6 and 12 weeks
Three days bladder diary
Time frame: 6 and 12 weeks
VAS (Visual Analog Scale)
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 18202577Madarame 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Due, PT, Ph.D principal investigator
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Soren Gräs, MD study director
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
Niels Klarskov, MD, lecturer study director
Department of Gynecology and Obstetrics, Herlev-Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and Kaatsu and Pelvic floor muscle training in people with Urinary Stress Incontinence, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form ) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.