Pelvic Floor Muscle WeaknessNCT03917615
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
A study testing pelvic floor contraction in people with Pelvic Floor Muscle Weakness, run by University of Haifa at 1 site in Israel.
Trial summary
The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness
- What is being tested?
- pelvic floor contraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Apr 2019to 1 Jun 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy students
- willing to participate in the study
Who cannot join
- has been treated before for pelvic floor rehabilitation
- active urinary tract infection
- pregnancy
- previous abdominal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Read the detailed description
Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.
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. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.
- Conditions
- Pelvic Floor Muscle Weakness
- Being tested
- pelvic floor contraction
- Keywords
- pelvic diaphragm, Physiotherapy students, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor contractionOther
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
| Study group | Role | What they receive |
|---|---|---|
| after "women health" course | Experimental | The participants will be instructed to contract the pelvic floor muscle Receives: Other: pelvic floor contraction |
| before "women health" course | Active comparator | The participants will be instructed to contract the pelvic floor muscle Receives: Other: pelvic floor contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
direction of urinary bladder displacement during contraction
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
Measured: baseline
urinary bladder displacement in millimeters
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: baseline
Secondary outcomes (1)
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction
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 Apr 2019
- Study start8 Apr 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups according to the year of physiotherapy school.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gali Dar, PhD, Study director, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917615
- Sponsor's protocol ID
- 123/19
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2019
- Last updated
- 30 Jul 2019
- 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
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 30152550
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
- ClinicalTrials.gov ID
- NCT03917615
- Acronym / sponsor ID
- 123/19
- Conditions
- Pelvic Floor Muscle Weakness
- Keywords
- pelvic diaphragm, Physiotherapy students, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 17 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 study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Detailed description
Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.
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. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups according to the year of physiotherapy school.
| Arm | Type | Receives |
|---|---|---|
| after "women health" course | Experimental | Other: pelvic floor contractionThe participants will be instructed to contract the pelvic floor muscle |
| before "women health" course | Active comparator | Other: pelvic floor contractionThe participants will be instructed to contract the pelvic floor muscle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy students
- willing to participate in the study
Key exclusion criteria (4 listed)
- has been treated before for pelvic floor rehabilitation
- active urinary tract infection
- 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 |
|---|---|---|
| pelvic floor contractionUltrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function | Other | after "women health" course, before "women health" course |
Primary outcome
direction of urinary bladder displacement during contraction
Time frame: baseline
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
urinary bladder displacement in millimeters
Time frame: baseline
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
1 secondary outcome
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 30 Jul 2019.
- 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.
Gali Dar, PhD study director
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 pelvic floor contraction 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 2 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 30 Jul 2019. 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?
direction of urinary bladder displacement during contraction (time frame: baseline). The study lists 2 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 NCT03917615, 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 30 Jul 2019.