Pelvic Floor Muscle WeaknessNCT03400540
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
A study testing verbal instruction in people with Pelvic Floor Muscle Weakness, run by University of Haifa at 1 site in Israel.
Trial summary
The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness
- What is being tested?
- verbal instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jan 2018to 1 Jun 2018
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing to participate in the study
Who cannot join
- pregnancy
- previous abdominal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound.
Read the detailed description
This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment.
A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort.
The participants will be divided into 2 groups randomly. Both groups will be given three different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound.
To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.
- Conditions
- Pelvic Floor Muscle Weakness
- Being tested
- verbal instruction
- Keywords
- verbal instruction, pelvic diaphragm, muscle contraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verbal instructionDiagnostic test
Also called diagnostic ultrasound assesment
Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:
1. "squeeze the pelvic floor muscles"
2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"
3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."
4. "contract all of the above together" Receives: Diagnostic Test: verbal instruction |
| Group B | Experimental | The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:
1. "squeeze the pelvic floor muscles"
2. "squeeze the anus"
3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."
4. "contract all of the above together" Receives: Diagnostic Test: verbal instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary bladder displacement in millimeters during first verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: up to 6 months
urinary bladder displacement in millimeters during second verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: up to 6 months
urinary bladder displacement in millimeters during third verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: up to 6 months
Secondary outcomes (6)
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction in each instruction
Measured: up to 6 months
demographic self reported questionnaire regarding height
height in meters
Measured: baseline
demographic self reported questionnaire regarding weight
weight in kilograms
Measured: baseline
self reported questionnaire regarding physical activity
number of practice per week
Measured: baseline
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
scale range 0-21 points. higher values represent worse outcome
Measured: baseline
BMI
measured in kg/m^2 and calculated from the reported values of weight and height
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start22 Jan 2018
- Primary completion23 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies 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
- Model description
- 2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, PHd, Study director, University of HaifaNoa Ben-Ami, PhD, Study director, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400540
- Sponsor's protocol ID
- AU-NBA-20171221
- Status last verified
- Jun 2018
- First submitted
- 29 Dec 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
Publications
Bo K, Sherburn M, Allen T. Transabdominal ultrasound measurement of pelvic floor muscle activity when activated directly or via a transversus abdominis muscle contraction. Neurourol Urodyn. 2003;22(6):582-8. doi: 10.1002/nau.10139.
PubMed 12951667Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.
PubMed 26215905
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
- ClinicalTrials.gov ID
- NCT03400540
- Acronym / sponsor ID
- AU-NBA-20171221
- Conditions
- Pelvic Floor Muscle Weakness
- Keywords
- verbal instruction, pelvic diaphragm, muscle contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound.
Detailed description
This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment.
A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort.
The participants will be divided into 2 groups randomly. Both groups will be given three different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound.
To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: verbal instructionThe participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: 1. "squeeze the pelvic floor muscles" 2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine" 3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." 4. "contract all of the above together" |
| Group B | Experimental | Diagnostic Test: verbal instructionThe participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: 1. "squeeze the pelvic floor muscles" 2. "squeeze the anus" 3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." 4. "contract all of the above together" |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- willing to participate in the study
Key exclusion criteria (2 listed)
- pregnancy
- previous abdominal surgeries
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 |
|---|---|---|
| verbal instructionAlso: diagnostic ultrasound assesmentVerbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function. | Diagnostic test | Group A, Group B |
Primary outcome
urinary bladder displacement in millimeters during first verbal instruction
Time frame: up to 6 months
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
urinary bladder displacement in millimeters during second verbal instruction
Time frame: up to 6 months
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
urinary bladder displacement in millimeters during third verbal instruction
Time frame: up to 6 months
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
6 secondary outcomes
pelvic floor muscles endurance of contraction in seconds
Time frame: up to 6 months
demographic self reported questionnaire regarding height
Time frame: baseline
demographic self reported questionnaire regarding weight
Time frame: baseline
self reported questionnaire regarding physical activity
Time frame: baseline
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
Time frame: baseline
BMI
Time frame: baseline
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 6 Jun 2018.
- Results publication: PubMed 12951667Bo K, Sherburn M, Allen T. Transabdominal ultrasound measurement of pelvic floor muscle activity when activated directly or via a transversus abdominis muscle contraction. Neurourol Urodyn. 2003;22(6):582-8. doi: 10.1002/nau.10139.
- Results publication: PubMed 26215905Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.
- Individual participant dataSharing planned: Yes. the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
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.
Gali Dar, PHd study director
University of Haifa
Noa Ben-Ami, PhD study director
Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verbal instruction in people with Pelvic Floor Muscle Weakness, run by University of Haifa at 1 site in Israel.
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 1 inclusion and 2 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 6 Jun 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 Israel. 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?
urinary bladder displacement in millimeters during first verbal instruction (time frame: up to 6 months). The study lists 3 primary outcomes in all. 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 NCT03400540, which also lists 2 linked publications.
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 6 Jun 2018.