Incontinence StressNCT06470620
The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women
An observational study of Incontinence Stress and Incontinence, run by University of Haifa at 1 site in Israel.
Trial summary
This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength. In addition, it will examines the association between PFM function, and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence Stress, Incontinence, Hip Pain Chronic
- What is being tested?
- pelvic floor muscle assessment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2024to 15 Sep 2025
- Phase
- Observational
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with and without hip related pain
Who may be able to join
- complaints of hip related pain,
- Visual Analog Scale (VAS) >3 for three months,
- with one or more of the symptoms relevant to the syndrome - (1) hip or groin pain produced by a certain movement or position, stiffness and limitation of movement or clicks from the hip joint, (2) examination A positive FADIR performed by the researcher before conducting the study
Who cannot join
- the presence of additional diagnoses of the slipped capital femoral epiphysis,
- Perthes disease,
- avascular necrosis, and osteoarthritis-Calve-Legg,
- neurological or Metabolism,
- surgery/fracture in the hip joint of which the woman complains,
- pregnancy or childbirth in the last year,
- Treatment of the pelvic floor in the last year.
- control group - health women without any pain or symptoms in the spine and lower extremities
Trial locations and contacts
1 site in 1 country.
Israel1 site
Haifa University, Department of PHysical Therapy
Haifa, Haifa District, 31905
About this study
This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength.
In addition, it will examines the association between PFM function, and anxiety.
Read the detailed description
This cross-sectional study will include women with symptoms of hip-related pain persisting > three months(research group), and women without hip pain (control group). A single session will include various assessments as follows: abdominal ultrasound examination to evaluate PFM function and endurance, in addition, each participant will evaluate her ability to perform correct contraction of PFM, hand-held dynamometer testing for hip rotator muscle strength, the International Consultation on Incontinence Questionnaire (ICIQ) for evaluating symptoms and impact of urinary incontinence, the International Hip Outcome Tool 12 for assessing hip function and pain, the Hospital Anxiety \& Depression Scale (HADS), and a functional performance task involving the hip muscles - a single-leg squat.
- Conditions
- Incontinence Stress, Incontinence, Hip Pain Chronic
- Being tested
- pelvic floor muscle assessment
- Keywords
- pelvic floor, women health, ultrasound, incontinence
- 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 assessmentDiagnostic test
Also called abdominal ultrasound
no intervention will be performed - several diagnostic assessments tools
| Study group | Role | What they receive |
|---|---|---|
| research group | women with hip-related pain Receives: Diagnostic Test: pelvic floor muscle assessment | |
| control group | healthy women without hip pain Receives: Diagnostic Test: pelvic floor muscle assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire
evaluating the frequency, severity and impact on quality of life of urinary incontinence. The score ranges from 0-21, with a higher score indicating greater severity
Measured: baseline
pelvic floor muscle function assessed as correct movement of the urinary bladder
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound. Upward movement is considered the correct direction describing good function of pelvic floor muscles
Measured: baseline
urinary bladder displacement in millimeters
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: baseline
pelvic floor muscles endurance of contraction in seconds
The participant is instructed to contract pelvic floor muscle and hold the contraction as long as possible. bladder status on ultrasound is assessed. When the bladder starts to move downward from its position the examination ends. (measured in sec).
Measured: baseline
Secondary outcomes (5)
muscle strength
hip muscle abduction sill be measure via hand held dynamometer
Measured: baseline
hip function assessment
International Hip Outcome Tool 12 questionnaire. range 0-100, with a high score indicates a high quality of life
Measured: baseline
self-reporting of fear and anxiety of hip pain regarding quality of life
Hospital Anxiety \& Depression Scale
Measured: baseline
hip range of motion
range of motion will be assessed with goniometer
Measured: baseline
function assesment
single leg squat
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Sep 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
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 Incontinence StressStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, Prof., Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470620
- Sponsor's protocol ID
- 122/24
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following study completion, a paper will be submitted to international professional journal
Publications
Dar G, Saban TS. The Perception of Pelvic Floor Muscle Function amongst Exercising Women Who Are Repeatedly Instructed to Contract Their Pelvic Floor Muscles. Healthcare (Basel). 2022 Sep 14;10(9):1768. doi: 10.3390/healthcare10091768.
PubMed 36141380
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women
- ClinicalTrials.gov ID
- NCT06470620
- Acronym / sponsor ID
- 122/24
- Conditions
- Incontinence Stress, Incontinence, Hip Pain Chronic
- Keywords
- pelvic floor, women health, ultrasound, incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 24 Jun 2024 (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.
This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength.
In addition, it will examines the association between PFM function, and anxiety.
Detailed description
This cross-sectional study will include women with symptoms of hip-related pain persisting > three months(research group), and women without hip pain (control group). A single session will include various assessments as follows: abdominal ultrasound examination to evaluate PFM function and endurance, in addition, each participant will evaluate her ability to perform correct contraction of PFM, hand-held dynamometer testing for hip rotator muscle strength, the International Consultation on Incontinence Questionnaire (ICIQ) for evaluating symptoms and impact of urinary incontinence, the International Hip Outcome Tool 12 for assessing hip function and pain, the Hospital Anxiety \& Depression Scale (HADS), and a functional performance task involving the hip muscles - a single-leg squat.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| research group | – | Diagnostic Test: pelvic floor muscle assessmentwomen with hip-related pain |
| control group | – | Diagnostic Test: pelvic floor muscle assessmenthealthy women without hip pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with and without hip related pain
Key inclusion criteria (3 listed)
- complaints of hip related pain,
- Visual Analog Scale (VAS) >3 for three months,
- with one or more of the symptoms relevant to the syndrome - (1) hip or groin pain produced by a certain movement or position, stiffness and limitation of movement or clicks from the hip joint, (2) examination A positive FADIR performed by the researcher before conducting the study
Key exclusion criteria (8 listed)
- the presence of additional diagnoses of the slipped capital femoral epiphysis,
- Perthes disease,
- avascular necrosis, and osteoarthritis-Calve-Legg,
- neurological or Metabolism,
- surgery/fracture in the hip joint of which the woman complains,
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 assessmentAlso: abdominal ultrasoundno intervention will be performed - several diagnostic assessments tools | Diagnostic test | control group, research group |
Primary outcome
International Consultation on Incontinence Questionnaire
Time frame: baseline
evaluating the frequency, severity and impact on quality of life of urinary incontinence. The score ranges from 0-21, with a higher score indicating greater severity
pelvic floor muscle function assessed as correct movement of the urinary bladder
Time frame: baseline
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound. Upward movement is considered the correct direction describing good function of pelvic floor muscles
urinary bladder displacement in millimeters
Time frame: baseline
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
pelvic floor muscles endurance of contraction in seconds
Time frame: baseline
The participant is instructed to contract pelvic floor muscle and hold the contraction as long as possible. bladder status on ultrasound is assessed. When the bladder starts to move downward from its position the examination ends. (measured in sec).
5 secondary outcomes
muscle strength
Time frame: baseline
hip function assessment
Time frame: baseline
self-reporting of fear and anxiety of hip pain regarding quality of life
Time frame: baseline
hip range of motion
Time frame: baseline
function assesment
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 26 Jan 2026.
- Results publication: PubMed 36141380Dar G, Saban TS. The Perception of Pelvic Floor Muscle Function amongst Exercising Women Who Are Repeatedly Instructed to Contract Their Pelvic Floor Muscles. Healthcare (Basel). 2022 Sep 14;10(9):1768. doi: 10.3390/healthcare10091768.
- Individual participant dataSharing planned: Yes. following study completion, a paper will be submitted to international professional journal
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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.
Gali Dar, Prof. 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?
An observational study of Incontinence Stress and Incontinence, 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 3 inclusion and 8 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 26 Jan 2026. 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?
International Consultation on Incontinence Questionnaire (time frame: baseline). The study lists 4 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 NCT06470620, 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 26 Jan 2026.