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OpenTrials
Completed

NCT Number: NCT06783699

Comparison Between Positive and Negative sUPP

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urinary incontinence in bladder diary

    Time frame: Between July 2009 and December 2023

    Subjective urinary incontinence described in bladder diary

Secondary outcomes

  1. Pad weight

    Time frame: Between July 2009 and December 2023

    Pad weight in pad test

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparisons of Urodynamic and Clinical Findings Between Those Positive and Negative sUPP in Women With Urodynamic Stress Incontinence

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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