NCT03256565

Brief Summary

Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be partly responsible for pathogenesis of women with stress urinary incontinence (SUI). Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this study was to search a surrogate for assessment of urethral hypermobility by correlating the Q-tip angle and the urodynamic variables in women with SUI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

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

Study Start

First participant enrolled

June 30, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

August 13, 2017

Last Update Submit

October 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlations of Q-tip angle with pressure transmission ratio

    Correlations of Q-tip angle with pressure transmission ratio at maximum urethral pressure during stress urethral pressure profile testing

    Between 2014 and 2020

Secondary Outcomes (3)

  • Correlations of Q-tip angle with the other parameters of urodynamic studies

    Between 2014 and 2020

  • Correlations of Q-tip angle with pad weight

    Between 2014 and 2020

  • Correlations of Q-tip angle with symptoms

    Between 2014 and 2020

Interventions

Q-tip testDIAGNOSTIC_TEST

A Q-Tip lubricated with anesthetic gel is inserted into the urethra, woman is then asked to cough and strain, and the angle of the Q-tip rotates is recorded.

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with stress urinary incontinence

You may qualify if:

  • all women with stress urinary incontinence, who underwent both Q-tip testing and urodynamic study, and completed the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire

You may not qualify if:

  • women who had incomplete exam or questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

August 13, 2017

First Posted

August 22, 2017

Study Start

June 30, 2017

Primary Completion

October 2, 2019

Study Completion

October 5, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations