Comparison Between Positive and Negative sUPP

Completed

• Conditions: Urodynamic Stress Incontinence

• Registration Number: NCT06783699
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Urodynamic stress incontinence is a prevalent condition among women, characterized by involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing, sneezing, or physical exertion. Stress urethral pressure profile measurement is an important diagnostic tool used during urodynamic studies to assess urethral function. In some women with urodynamic stress incontinence, involuntary urine leakage occurs during this measurement, yet the clinical and urodynamic significance of this leakage remains unclear. This study aims to elucidate the differences in clinical and urodynamic findings between women with urodynamic stress incontinence who experience involuntary urine leakage during stress urethral pressure profile measurement and those who do not. Between July 2009 and December 2023, a total of 481 women with urodynamic stress incontinence were included and divided into positive and negative sUPP groups. The medical records, including urodynamic study, 3-day bladder dairy and questionnaires regarding lower urinary tract symptoms were reviewed.

Detailed Description

Hypothesis / aims of study Involuntary urine leakage has been observed during stress urethral pressure measurement in women with urodynamic stress incontinence (USI). However, to our knowledge, its clinical significance and urodynamic association remained undetermined. Therefore, the objective of this study is to elucidate the above differences between those with versus without involuntary urine leakage during the measurement of stress urethral pressure in women with USI.

Study design, materials and methods Between July 2009 and December 2023, medical records, including urodynamic data, bladder dairy data and questionnaires, including patient perception of bladder condition (PPBC), urgency severity scale (USS), overactive bladder symptom score (OABSS), urogenital distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), and King's Health Questionnaire (KHQ), of all women with USI were reviewed to see if there was any involuntary leakage of urine during stress urethral pressure measurement.

STATA software was used for statistical analysis. The Wilcoxon rank sum test or the Chi-square test were used for statistical analysis, as appropriate. A p \< 0.05 was considered statistically significant. Linear regression analysis was also performed with an adjustment of overactive bladder syndrome (OAB) to elucidate the real clinical and urodynamic associations about the leak during stress urethral pressure measurement.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-28
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-31
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 481

Inclusion Criteria

• >20 y/o
• Women with lower urinary tract symptoms
• Received urodynamic stress incontinence and was diagnosed with urodynamic stress incontinence

Exclusion Criteria

• Women who are pregnant
• With chronic pelvic inflammatory disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary incontinence in bladder diary	Between July 2009 and December 2023	Subjective urinary incontinence described in bladder diary

Secondary Outcome Measures

Name	Time	Method
Pad weight	Between July 2009 and December 2023	Pad weight in pad test

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan