Urinary IncontinenceNCT03940794
Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence
A study testing Verbal instruction in people with Urinary Incontinence, run by Ariel University at 1 site in Israel.
Trial summary
The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence. and to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Verbal instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Jul 2019to 1 Mar 2020
- 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
- Diagnosis of urinary incontinence
- Understand the language and simple instruction
- Willing to participate in the study
Who cannot join
- Has been treated before for pelvic floor rehabilitation by a physiotherapist
- Received medication or surgery for the problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial
The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence.
and to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback.
Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Read the detailed description
A self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the Meuhedet Institutes' physiotherapy clinics.
Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as biofeedback.
The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer 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
- Urinary Incontinence
- Being tested
- Verbal instruction
- Keywords
- Urinary incontinence, Pelvic floor muscle contraction, Transabdominal ultrasound, Verbal instructions
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal instructionOther
Also called Trans abdominal Ultrasound examination for pelvic floor contraction
Verbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
| Study group | Role | What they receive |
|---|---|---|
| Verbal instruction | Experimental | The participants will be instructed to contract the pelvic floor muscle with the following verbal instruction: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating".Those who will not be able to contract will be taught by the ultrasound as biofeedback. Receives: Other: 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 verbal instructions
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: baseline
Secondary outcomes (2)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points.
higher values represent worse outcome
Measured: Baseline
Pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction in each instruction
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start17 Jul 2019
- Primary completion23 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment all participants will receive the same verbal instruction
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noa Ben Ami, PhD, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940794
- Sponsor's protocol ID
- ArielU
- Status last verified
- Jun 2020
- First submitted
- 5 May 2019
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.
Publications
Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.
PubMed 30152550Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.
PubMed 15733051Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
PubMed 28977091
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03940794
- Acronym / sponsor ID
- ArielU
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, Pelvic floor muscle contraction, Transabdominal ultrasound, Verbal instructions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 7 May 2019 (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 investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence.
and to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback.
Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Detailed description
A self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the Meuhedet Institutes' physiotherapy clinics.
Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as biofeedback.
The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment all participants will receive the same verbal instruction
| Arm | Type | Receives |
|---|---|---|
| Verbal instruction | Experimental | Other: Verbal instructionThe participants will be instructed to contract the pelvic floor muscle with the following verbal instruction: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating".Those who will not be able to contract will be taught by the ultrasound as biofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of urinary incontinence
- Understand the language and simple instruction
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Has been treated before for pelvic floor rehabilitation by a physiotherapist
- Received medication or surgery for the problem
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: Trans abdominal Ultrasound examination for pelvic floor contractionVerbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function. | Other | Verbal instruction |
Primary outcome
urinary bladder displacement in millimeters during verbal instructions
Time frame: baseline
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
2 secondary outcomes
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: Baseline
Pelvic floor muscles endurance of contraction in seconds
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 24 Jun 2020.
- Results publication: PubMed 30152550Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.
- Results publication: PubMed 15733051Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.
- Results publication: PubMed 28977091Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
- Individual participant dataSharing planned: No. the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.
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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.
Noa Ben Ami, PhD principal investigator
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 Urinary Incontinence, run by Ariel University 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 3 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 24 Jun 2020. 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 verbal instructions (time frame: baseline). 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 NCT03940794, which also lists 3 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 24 Jun 2020.