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Completed

NCT Number: NCT03256565

Q-tip Test and Urodynamic Study

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q-tip test

Diagnostic 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Correlations of Q-tip angle with symptoms

    Time frame: Between 2014 and 2020

    Correlations of Q-tip angle with questionnaires of urinary symptoms

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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