Urodynamic Stress IncontinenceNCT05205395
Relationship Between Q-tip Test and Urethral Hypermobility
An observational study of Urodynamic Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
Q-tip test was applied for evaluation of urethral hypermobility (UH) in stress-incontinent women. It is still unknown whether there is an alternative method for the assessment of UH in a less invasive way or not. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Urodynamic Stress Incontinence
- What is being tested?
- Transperineal ultrasound
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Jan 2014
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2009 and January 2014, a total of 258 women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. A retrospective chart review was performed. Women with more or equal to stage 2 pelvic organ prolapse (POP) defined by POP-quantification system (POP-Q) and received concomitant transvaginal mesh (TVM) surgery were excluded. Women with incomplete ultrasound records were also excluded.
Who may be able to join
- Women with urodynamic stress incontinence (USI)
- Scheduled for mid-urethral sling surgery
Who cannot join
- Women with more or equal to stage 2 pelvic organ prolapse (POP) defined by POP-quantification system (POP-Q) and received concomitant transvaginal mesh (TVM) surgery
- Women with incomplete ultrasound records
About this study
Official title: Relationship Between Q-tip Test and Urethral Hypermobility on Perineal Ultrasound for Women With Urodynamic Stress Incontinence
Q-tip test was applied for evaluation of urethral hypermobility (UH) in stress-incontinent women. It is still unknown whether there is an alternative method for the assessment of UH in a less invasive way or not.
We aim to assess the correlation between the overall rest-stress distance measured by transperineal ultrasound (TPUS) and Q-tip test angle in women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery (MUS), and determine a cut off value of rest-stress distance for predicting UH.
Read the detailed description
Between January 2009 and January 2014, women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. A retrospective chart review was performed. This study received approval from the Institutional Review Board of Kaohsiung Medical University Hospital (ID:KMUHIRB-E(I)-20210275), by which relevant guidelines and regulations were followed accordingly. Informed consent was obtained from all participants before surgeries. The Q-tip test was performed via a cotton swab with the patient in a 45-degree reclining. After lubricated with 2% lidocaine jelly, the cotton swab was inserted with the tip over bladder neck. The angle changes from rest to maximal straining were obtained for 3 times, and the maximum of angle change was recorded. The TPUS was performed by two experienced urogynecologist according to KMUH-TPUS protocol. The Voluson General Electric Sonography, expert 730 type (GE, Healthcare Ultrasound, Zipf, Austria) Ultrasonography was used with 3.5 MHZ curved linear-array transducer placed between the major labia and underneath the external urethral orifice. The measurement was done on the midsagittal plane to obtain the image of pubic symphysis, urethra, and bladder in a view. Ultrasonic measurement of the overall rest-stress distance was define as the linear distance of bladder neck position change from resting status to maximal strain. The rest-stress distance was obtained for 3 times, and the maximum of distance was recorded. The primary outcome of this study was the correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck in TPUS. The secondary outcome was the optimal cut off value of the rest-stress distance to predict UH.
- Conditions
- Urodynamic Stress Incontinence
- Being tested
- Transperineal ultrasound
- Keywords
- Urodynamic stress incontinence, Q-tip test, Transperineal ultrasound, Urethral hypermobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal ultrasoundDiagnostic test
Ultrasonography was used with curved linear-array transducer placed between the major labia and underneath the external urethral orifice. The measurement was done on the midsagittal plane to obtain the image of pubic symphysis, urethra, and bladder in a view. Ultrasonic measurement of the overall rest-stress distance was define as the linear distance of bladder neck position change from resting status to maximal strain.
| Study group | Role | What they receive |
|---|---|---|
| Women with stress incontinence | Women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. Receives: Diagnostic Test: Transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Q-tip test and therest-stress distance
The correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck
Measured: January 2009 to January 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jan 2009
- Primary completion31 Jan 2014
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Stress 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Yu Long, Principal investigator, Kaohsiung Municipal Siaogang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205395
- Sponsor's protocol ID
- KMUHIRB-E(I)20210275
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Publications
Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004 Sep;104(3):607-20. doi: 10.1097/01.AOG.0000137874.84862.94.
PubMed 15339776DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
PubMed 8203431Crystle CD, Charme LS, Copeland WE. Q-tip test in stress urinary incontinence. Obstet Gynecol. 1971 Aug;38(2):313-5. No abstract available.
PubMed 5105346Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
PubMed 20350640Walters MD, Shields LE. The diagnostic value of history, physical examination, and the Q-tip cotton swab test in women with urinary incontinence. Am J Obstet Gynecol. 1988 Jul;159(1):145-9. doi: 10.1016/0002-9378(88)90510-8.
PubMed 3394734Yun JH, Kim JH, Park S, Lee C. Changes in the Q-tip angle in relation to the patient position and bladder filling. BMC Urol. 2015 Oct 7;15:101. doi: 10.1186/s12894-015-0096-4.
PubMed 26446765Chen GD, Su TH, Lin LY. Applicability of perineal sonography in anatomical evaluation of bladder neck in women with and without genuine stress incontinence. J Clin Ultrasound. 1997 May;25(4):189-94. doi: 10.1002/(sici)1097-0096(199705)25:43.0.co;2-a.
PubMed 9142618Lin KL, Juan YS, Lo TS, Liu CM, Tsai EM, Long CY. Three-dimensional ultrasonographic assessment of compression effect on urethra following tension-free vaginal tape and transobturator tape procedures. Ultrasound Obstet Gynecol. 2012 Apr;39(4):452-7. doi: 10.1002/uog.9071.
PubMed 21656867
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Q-tip Test and Urethral Hypermobility on Perineal Ultrasound for Women With Urodynamic Stress Incontinence
- ClinicalTrials.gov ID
- NCT05205395
- Acronym / sponsor ID
- KMUHIRB-E(I)20210275
- Conditions
- Urodynamic Stress Incontinence
- Keywords
- Urodynamic stress incontinence, Q-tip test, Transperineal ultrasound, Urethral hypermobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 25 Jan 2022 (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.
Q-tip test was applied for evaluation of urethral hypermobility (UH) in stress-incontinent women. It is still unknown whether there is an alternative method for the assessment of UH in a less invasive way or not.
We aim to assess the correlation between the overall rest-stress distance measured by transperineal ultrasound (TPUS) and Q-tip test angle in women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery (MUS), and determine a cut off value of rest-stress distance for predicting UH.
Detailed description
Between January 2009 and January 2014, women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. A retrospective chart review was performed. This study received approval from the Institutional Review Board of Kaohsiung Medical University Hospital (ID:KMUHIRB-E(I)-20210275), by which relevant guidelines and regulations were followed accordingly. Informed consent was obtained from all participants before surgeries. The Q-tip test was performed via a cotton swab with the patient in a 45-degree reclining. After lubricated with 2% lidocaine jelly, the cotton swab was inserted with the tip over bladder neck. The angle changes from rest to maximal straining were obtained for 3 times, and the maximum of angle change was recorded. The TPUS was performed by two experienced urogynecologist according to KMUH-TPUS protocol. The Voluson General Electric Sonography, expert 730 type (GE, Healthcare Ultrasound, Zipf, Austria) Ultrasonography was used with 3.5 MHZ curved linear-array transducer placed between the major labia and underneath the external urethral orifice. The measurement was done on the midsagittal plane to obtain the image of pubic symphysis, urethra, and bladder in a view. Ultrasonic measurement of the overall rest-stress distance was define as the linear distance of bladder neck position change from resting status to maximal strain. The rest-stress distance was obtained for 3 times, and the maximum of distance was recorded. The primary outcome of this study was the correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck in TPUS. The secondary outcome was the optimal cut off value of the rest-stress distance to predict UH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with stress incontinence | – | Diagnostic Test: Transperineal ultrasoundWomen with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2009 and January 2014, a total of 258 women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. A retrospective chart review was performed. Women with more or equal to stage 2 pelvic organ prolapse (POP) defined by POP-quantification system (POP-Q) and received concomitant transvaginal mesh (TVM) surgery were excluded. Women with incomplete ultrasound records were also excluded.
Key inclusion criteria (2 listed)
- Women with urodynamic stress incontinence (USI)
- Scheduled for mid-urethral sling surgery
Key exclusion criteria (2 listed)
- Women with more or equal to stage 2 pelvic organ prolapse (POP) defined by POP-quantification system (POP-Q) and received concomitant transvaginal mesh (TVM) surgery
- Women with incomplete ultrasound records
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 |
|---|---|---|
| Transperineal ultrasoundUltrasonography was used with curved linear-array transducer placed between the major labia and underneath the external urethral orifice. The measurement was done on the midsagittal plane to obtain the image of pubic symphysis, urethra, and bladder in a view. Ultrasonic measurement of the overall rest-stress distance was define as the linear distance of bladder neck position change from resting status to maximal strain. | Diagnostic test | Women with stress incontinence |
Primary outcome
Q-tip test and therest-stress distance
Time frame: January 2009 to January 2014
The correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck
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 25 Jan 2022.
- Results publication: PubMed 15339776Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004 Sep;104(3):607-20. doi: 10.1097/01.AOG.0000137874.84862.94.
- Results publication: PubMed 8203431DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
- Results publication: PubMed 5105346Crystle CD, Charme LS, Copeland WE. Q-tip test in stress urinary incontinence. Obstet Gynecol. 1971 Aug;38(2):313-5. No abstract available.
- Results publication: PubMed 20350640Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
- Results publication: PubMed 3394734Walters MD, Shields LE. The diagnostic value of history, physical examination, and the Q-tip cotton swab test in women with urinary incontinence. Am J Obstet Gynecol. 1988 Jul;159(1):145-9. doi: 10.1016/0002-9378(88)90510-8.
- Results publication: PubMed 26446765Yun JH, Kim JH, Park S, Lee C. Changes in the Q-tip angle in relation to the patient position and bladder filling. BMC Urol. 2015 Oct 7;15:101. doi: 10.1186/s12894-015-0096-4.
- Results publication: PubMed 9142618Chen GD, Su TH, Lin LY. Applicability of perineal sonography in anatomical evaluation of bladder neck in women with and without genuine stress incontinence. J Clin Ultrasound. 1997 May;25(4):189-94. doi: 10.1002/(sici)1097-0096(199705)25:43.0.co;2-a.
- Results publication: PubMed 21656867Lin KL, Juan YS, Lo TS, Liu CM, Tsai EM, Long CY. Three-dimensional ultrasonographic assessment of compression effect on urethra following tension-free vaginal tape and transobturator tape procedures. Ultrasound Obstet Gynecol. 2012 Apr;39(4):452-7. doi: 10.1002/uog.9071.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Related trials for Urodynamic Stress Incontinence
Not yet recruiting
Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence
Stress Urinary Incontinence
Recruiting
Does Use of a Pre-Procedure Educational Video for Urodynamic Testing Reduces Anxiety?
Urinary Incontinence, Urinary Bladder Overactive
Enrolling by invitation
Urethral Vascularization and Urodynamics
Stress Urinary Incontinence, Ultrasound
Recruiting
Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study
Stress Incontinence Female, Urodynamic Exam
Not yet recruitingObservational study
PFU vs. UDS in SUI
Stress Urinary Incontinence (SUI)
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.
Cheng-Yu Long principal investigator
Kaohsiung Municipal Siaogang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Urodynamic Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 2 inclusion and 2 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Q-tip test and therest-stress distance (time frame: January 2009 to January 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205395, which also lists 8 linked publications.
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 25 Jan 2022.