NCT03825653

Brief Summary

This study will be conducted to assess biomechanical alignment of lower limb as a predictor for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

January 29, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

January 30, 2019

Last Update Submit

January 30, 2019

Conditions

Keywords

stress urinary incontinencepelvic tiltankle position

Outcome Measures

Primary Outcomes (3)

  • Post-void residual volume PVR

    Transabdominal ultrasound it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition

    30 minutes for every patient

  • posterior urethrovesical angle

    perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman

    30 minutes for every patient

  • pelvic tilt

    lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt

    30 minutes for every patient

Secondary Outcomes (2)

  • ankle range of motion

    10 minutes for every patient

  • BMI

    10 minutes for every patient

Study Arms (1)

one group

This study will be carried out on three hundred postmenopausal.They will be selected from gynecological outpatient clinic of (Oum El Masryn Hospital). their age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. They are complaining from stress urinary incontinence.

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2

You may qualify if:

  • Subjects will be 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2

You may not qualify if:

  • previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index \>30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

yara n zaki, M sc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of biomechanics

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

January 29, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 31, 2019

Record last verified: 2018-12