NCT06783699

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 28, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
Last Updated

January 20, 2025

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Keywords

Urodynamic stress incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence in bladder diary

    Subjective urinary incontinence described in bladder diary

    Between July 2009 and December 2023

Secondary Outcomes (1)

  • Pad weight

    Between July 2009 and December 2023

Study Arms (2)

Positive sUPP

Involuntary urine leak during cough stress test in urethral pressure profile

Negative sUPP

No urine leak during cough stress test in urethral pressure profile

Eligibility Criteria

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

Women aged more than 20-year-old with lower urinary tract symptoms underwent urodynamic study and were diagnosed with urodynamic stress incontinence.

You may qualify if:

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

You may not qualify if:

  • Women who are pregnant
  • With chronic pelvic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

  • Wu PC, Hsiao SM, Lin HH. Prevalence and predictors of nocturnal polyuria in females with overactive bladder syndrome. World J Urol. 2022 Feb;40(2):519-527. doi: 10.1007/s00345-021-03865-5. Epub 2021 Nov 11.

  • Hsiao SM, Wu PC, Chang TC, Chen CH, Lin HH. Urodynamic and Bladder Diary Factors Predict Overactive Bladder-wet in Women: A Comparison With Overactive Bladder-dry. Int Neurourol J. 2019 Mar;23(1):69-74. doi: 10.5213/inj.1836212.106. Epub 2019 Mar 31.

  • Hsiao SM, Hsiao CF, Chen CH, Chang TC, Wu WY, Lin HH. Evaluation of bladder diary parameters based on correlation with the volume at strong desire to void in filling cystometry. PLoS One. 2013 Jul 29;8(7):e69946. doi: 10.1371/journal.pone.0069946. Print 2013.

  • Rosier PFWM, Schaefer W, Lose G, Goldman HB, Guralnick M, Eustice S, Dickinson T, Hashim H. International Continence Society Good Urodynamic Practices and Terms 2016: Urodynamics, uroflowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. 2017 Jun;36(5):1243-1260. doi: 10.1002/nau.23124. Epub 2016 Dec 5.

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

Study Officials

  • Ho-Hsiung Lin, M.D. Ph.D

    National Taiwan University 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

January 14, 2025

First Posted

January 20, 2025

Study Start

June 28, 2024

Primary Completion

July 31, 2024

Study Completion

August 31, 2024

Last Updated

January 20, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Data will be shared under request.

Locations