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Q-tip Test and Urodynamic Study

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ClinicalTrials.gov Identifier: NCT03256565
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Diagnostic Test: Q-tip test

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.

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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : October 2, 2019
Actual Study Completion Date : October 5, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women with stress urinary incontinence
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256565


Locations
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Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao, New Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
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Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT03256565    
Other Study ID Numbers: 106060-E
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders