Pelvic Floor Muscle WeaknessNCT03903627
Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients
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 investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles in post stroke patients. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 77 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Apr 2019to 1 Feb 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- one to 6 months post first stroke
- understand the language and simple instruction
- willing to participate in the study
- mini mental assessment >21
Who cannot join
- Aphasia
- side neglect
- active urinary tract infection
- has been treated before for pelvic floor rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles in post stroke patients. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound.
Read the detailed description
Sub-acute stroke patients during the rehabilitation period in the rehabilitation hospital will be examined. 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 a 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
- Pelvic Floor Muscle Weakness
- Being tested
- verbal instruction
- Keywords
- verbal cue, pelvic diaphragm, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verbal instructionOther
Also called transabdominal 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 |
|---|---|---|
| Verbal instruction | Experimental | The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:
(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 a 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 (3)
International Consultation on Incontinence Questionnaire
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
Functional Independence Measurement (FIM) tool
assess and grade the functional status of a person based on the level of assistance he or she requires
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start8 Apr 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 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 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
- Not applicable
- Intervention model
- Single group
- Model description
- all participants will receive the same verbal instruction
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Sponsor
- Investigators
- Noa Ben-Ami, PhD, Principal investigator, Ariel UniversityGali Dar, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903627
- Sponsor's protocol ID
- 0026-18-LOE
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 19 May 2020
- 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
Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.
PubMed 15014939Shin DC, Shin SH, Lee MM, Lee KJ, Song CH. Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial. Clin Rehabil. 2016 Mar;30(3):259-67. doi: 10.1177/0269215515578695. Epub 2015 Apr 10.
PubMed 25862769Ben 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 30152550
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT03903627
- Acronym / sponsor ID
- 0026-18-LOE
- Conditions
- Pelvic Floor Muscle Weakness
- Keywords
- verbal cue, pelvic diaphragm, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Apr 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 in post stroke patients. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound.
Detailed description
Sub-acute stroke patients during the rehabilitation period in the rehabilitation hospital will be examined. 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 a 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
- all participants will receive the same verbal instruction
| Arm | Type | Receives |
|---|---|---|
| Verbal instruction | Experimental | Other: verbal instructionThe participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: (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 a biofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- one to 6 months post first stroke
- understand the language and simple instruction
- willing to participate in the study
- mini mental assessment >21
Key exclusion criteria (4 listed)
- Aphasia
- side neglect
- active urinary tract infection
- has been treated before for pelvic floor rehabilitation
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: transabdominal 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. | 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
3 secondary outcomes
International Consultation on Incontinence Questionnaire
Time frame: baseline
pelvic floor muscles endurance of contraction in seconds
Time frame: baseline
Functional Independence Measurement (FIM) tool
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 19 May 2020.
- Results publication: PubMed 15014939Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.
- Results publication: PubMed 25862769Shin DC, Shin SH, Lee MM, Lee KJ, Song CH. Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial. Clin Rehabil. 2016 Mar;30(3):259-67. doi: 10.1177/0269215515578695. Epub 2015 Apr 10.
- 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.
- 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.
Noa Ben-Ami, PhD principal investigator
Ariel University
Gali Dar, PhD principal investigator
University of Haifa
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 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 19 May 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 NCT03903627, 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 19 May 2020.