Clinical trial NCT05205395: Relationship Between Q-tip Test and Urethral Hypermobility
Official title: Relationship Between Q-tip Test and Urethral Hypermobility on Perineal Ultrasound for Women With Urodynamic Stress Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urodynamic Stress Incontinence
Keywords: Urodynamic stress incontinence
Q-tip test
Transperineal ultrasound
Urethral hypermobility
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 258
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Q-tip test and therest-stress distance
timeFrame: January 2009 to January 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Municipal Siaogang Hospital
name: Cheng-Yu Long
role: PRINCIPAL_INVESTIGATOR
References:
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