NCT06470620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

June 17, 2024

Last Update Submit

January 23, 2026

Conditions

Keywords

pelvic floorwomen healthultrasoundincontinence

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    baseline

  • urinary bladder displacement in millimeters

    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    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).

    baseline

Secondary Outcomes (5)

  • muscle strength

    baseline

  • hip function assessment

    baseline

  • self-reporting of fear and anxiety of hip pain regarding quality of life

    baseline

  • hip range of motion

    baseline

  • function assesment

    baseline

Study Arms (2)

research group

women with hip-related pain

Diagnostic Test: pelvic floor muscle assessment

control group

healthy women without hip pain

Diagnostic Test: pelvic floor muscle assessment

Interventions

no intervention will be performed - several diagnostic assessments tools

Also known as: abdominal ultrasound
control groupresearch group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe study examine pelvic floor muscle function among women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women with and without hip related pain

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University, Department of PHysical Therapy

Haifa, Haifa District, 31905, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gali Dar, Prof.

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, Prof.

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

September 1, 2024

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

following study completion, a paper will be submitted to international professional journal

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 months following end of study

Locations