Stress Urinary IncontinenceNCT03256565
Q-tip Test and Urodynamic Study
An observational study of Stress Urinary Incontinence, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Q-tip test
- How many people
- 176 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jun 2017to 5 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women with stress urinary incontinence
Who may be able to join
- 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
Who cannot join
- women who had incomplete exam or questionnaires
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Q-tip test
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between 2014 and 2020
Secondary outcomes (3)
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
Measured: Between 2014 and 2020
Correlations of Q-tip angle with pad weight
Correlations of Q-tip angle with 20 min pad testing result
Measured: Between 2014 and 2020
Correlations of Q-tip angle with symptoms
Correlations of Q-tip angle with questionnaires of urinary symptoms
Measured: Between 2014 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start30 Jun 2017
- Primary completion2 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256565
- Sponsor's protocol ID
- 106060-E
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2017
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03256565
- Acronym / sponsor ID
- 106060-E
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women with stress urinary incontinence
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- women who had incomplete exam or questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-tip testA 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. | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
Correlations of Q-tip angle with the other parameters of urodynamic studies
Time frame: Between 2014 and 2020
Correlations of Q-tip angle with pad weight
Time frame: Between 2014 and 2020
Correlations of Q-tip angle with symptoms
Time frame: Between 2014 and 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations of Q-tip angle with pressure transmission ratio (time frame: Between 2014 and 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.