NCT05205395

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
Last Updated

January 25, 2022

Status Verified

December 1, 2021

Enrollment Period

5.1 years

First QC Date

December 21, 2021

Last Update Submit

January 19, 2022

Conditions

Keywords

Urodynamic stress incontinenceQ-tip testTransperineal ultrasoundUrethral hypermobility

Outcome Measures

Primary Outcomes (1)

  • 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

    January 2009 to January 2014

Study Arms (1)

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.

Diagnostic Test: Transperineal ultrasound

Interventions

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.

Women with stress incontinence

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

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

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Cheng-Yu Long

    Kaohsiung Municipal Siaogang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 25, 2022

Study Start

January 1, 2009

Primary Completion

January 31, 2014

Study Completion

January 31, 2014

Last Updated

January 25, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

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.