Relationship Between Q-tip Test and Urethral Hypermobility

NCT ID: NCT05205395

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Urodynamic Stress Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Transperineal ultrasound

Intervention Type DIAGNOSTIC_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.

Interventions

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Transperineal ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women with urodynamic stress incontinence (USI)
* Scheduled for mid-urethral sling surgery

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Yu Long

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Municipal Siaogang Hospital

References

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Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004 Sep;104(3):607-20. doi: 10.1097/01.AOG.0000137874.84862.94.

Reference Type RESULT
PMID: 15339776 (View on PubMed)

DeLancey 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.

Reference Type RESULT
PMID: 8203431 (View on PubMed)

Crystle CD, Charme LS, Copeland WE. Q-tip test in stress urinary incontinence. Obstet Gynecol. 1971 Aug;38(2):313-5. No abstract available.

Reference Type RESULT
PMID: 5105346 (View on PubMed)

Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.

Reference Type RESULT
PMID: 20350640 (View on PubMed)

Walters 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.

Reference Type RESULT
PMID: 3394734 (View on PubMed)

Yun 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.

Reference Type RESULT
PMID: 26446765 (View on PubMed)

Chen 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.

Reference Type RESULT
PMID: 9142618 (View on PubMed)

Lin 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.

Reference Type RESULT
PMID: 21656867 (View on PubMed)

Other Identifiers

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KMUHIRB-E(I)20210275

Identifier Type: -

Identifier Source: org_study_id

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