NCT04288648

Brief Summary

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

February 26, 2020

Last Update Submit

November 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • direction of urinary bladder displacement during contraction

    upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

    baseline

Secondary Outcomes (3)

  • urinary bladder displacement in millimeters

    baseline

  • pelvic floor muscles endurance of contraction in seconds

    baseline

  • questioned about the degree of difficulty contracting the pelvic floor.

    baseline

Study Arms (2)

SUI group

Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction.

Diagnostic Test: ultrasound examination

control group

Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction.

Diagnostic Test: ultrasound examination

Interventions

ultrasound examinationDIAGNOSTIC_TEST

ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.

Also known as: transabdominal ultrasound assessment
SUI groupcontrol group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen only
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women, between ages 18-45 with and without USI.

You may qualify if:

  • willing to participate in the study
  • being able to squat for over 10 seconds.

You may not qualify if:

  • Other types of urinary leakage
  • receiving pelvic floor treatments in the past or present
  • active urinary or vaginal infections
  • neurological diseases
  • urologic, gynecologic or abdominal surgery
  • pelvic organ prolapse
  • pregnancy
  • chronic cough
  • constipation
  • unbalanced diabetes and the use of medication that affects urination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University, Department of PHysical Therapy

Haifa, 31905, Israel

Location

Related Publications (1)

  • Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.

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, PhD

    Gali Dar, Department of Physical Therapy, University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

May 17, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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

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

Locations