Relationship Between Q-tip Test and Urethral Hypermobility

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05205395
• Collaborator: (none)
• Enrollment: 258
• Actual Duration (Months): 61

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urodynamic Stress Incontinence	Diagnostic Test: Transperineal ultrasound

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

• Study Type: Observational
• Actual Enrollment: 258 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Relationship Between Q-tip Test and Urethral Hypermobility on Perineal Ultrasound for Women With Urodynamic Stress Incontinence
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 31, 2014
• Actual Study Completion Date: Jan 31, 2014

Arms and Interventions

Arm

Intervention/Treatment

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; 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.

Outcome Measures

Primary Outcome Measures

1. Q-tip test and therest-stress distance [January 2009 to January 2014]

   The correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Principal Investigator: Cheng-Yu Long, Kaohsiung Municipal Siaogang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05205395
• Other Study ID Numbers: KMUHIRB-E(I)20210275
• First Posted: Jan 25, 2022
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: Urodynamic stress incontinence; Q-tip test; Transperineal ultrasound; Urethral hypermobility
• Additional relevant MeSH terms: Urinary Incontinence, Stress

Study Results

No Results Posted as of Jan 25, 2022