Q-tip Test and Urodynamic Study

Stress Urinary Incontinence Clinical Trial

Official title:

Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256565
• Other study ID #: 106060-E
• Status: Completed
• Start date: June 30, 2017
• Est. completion date: October 5, 2019

Study information

• Verified date: October 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 5, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Diagnostic Test:
• Q-tip 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.

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlations of Q-tip angle with the other parameters of urodynamic studies	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
Secondary	Correlations of Q-tip angle with pad weight	Correlations of Q-tip angle with 20 min pad testing result	Between 2014 and 2020
Secondary	Correlations of Q-tip angle with symptoms	Correlations of Q-tip angle with questionnaires of urinary symptoms	Between 2014 and 2020