- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03256565
Q-tip Test and Urodynamic Study
October 19, 2019 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All women with SUI and underwent Q-tip testing were reviewed.
Patient characteristics, degree of prolapse determined by Pelvic Organ Prolapse Quantification system, Q-tip angle, the results of urodynamic studies, the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire were reviewed from their medical records.
Spearman correlation test, and univariate and multivariate backward stepwise linear regression analysis were performed as appropriate.
Study Type
Observational
Enrollment (Actual)
176
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Taipei
-
Banqiao, New Taipei, Taiwan, 22050
- Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
women with stress urinary incontinence
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- women who had incomplete exam or questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlations of Q-tip angle with pressure transmission ratio
Time Frame: Between 2014 and 2020
|
Correlations of Q-tip angle with pressure transmission ratio at maximum urethral pressure during stress urethral pressure profile testing
|
Between 2014 and 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlations of Q-tip angle with the other parameters of urodynamic studies
Time Frame: Between 2014 and 2020
|
clinical and urodynamic variables include maximum flow rate, voided volume, post-void residual, voiding time, strong desire, PdetQmax, MUCP, functional profile length
|
Between 2014 and 2020
|
|
Correlations of Q-tip angle with pad weight
Time Frame: Between 2014 and 2020
|
Correlations of Q-tip angle with 20 min pad testing result
|
Between 2014 and 2020
|
|
Correlations of Q-tip angle with symptoms
Time Frame: Between 2014 and 2020
|
Correlations of Q-tip angle with questionnaires of urinary symptoms
|
Between 2014 and 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2017
Primary Completion (Actual)
October 2, 2019
Study Completion (Actual)
October 5, 2019
Study Registration Dates
First Submitted
August 13, 2017
First Submitted That Met QC Criteria
August 17, 2017
First Posted (Actual)
August 22, 2017
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 19, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106060-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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