Urodynamic Stress IncontinenceNCT06783699
Comparison Between Positive and Negative sUPP
An observational study of Urodynamic Stress Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urodynamic Stress Incontinence
- How many people
- 481 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged more than 20-year-old with lower urinary tract symptoms underwent urodynamic study and were diagnosed with urodynamic stress incontinence.
Who may be able to join
- >20 y/o
- Women with lower urinary tract symptoms
- Received urodynamic stress incontinence and was diagnosed with urodynamic stress incontinence
Who cannot join
- Women who are pregnant
- With chronic pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Urodynamic and Clinical Findings Between Those Positive and Negative sUPP in Women With Urodynamic Stress Incontinence
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.
Read the 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.
- Conditions
- Urodynamic Stress Incontinence
- Keywords
- Urodynamic stress incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence in bladder diary
Subjective urinary incontinence described in bladder diary
Measured: Between July 2009 and December 2023
Secondary outcomes (1)
Pad weight
Pad weight in pad test
Measured: Between July 2009 and December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start28 Jun 2024
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, M.D. Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783699
- Sponsor's protocol ID
- 202406048RINC
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared under request.
Publications
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.
PubMed 34762173Hsiao 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.
PubMed 30943696Hsiao 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.
PubMed 23922866Rosier 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.
PubMed 27917521Haylen 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.
PubMed 19941278
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Urodynamic and Clinical Findings Between Those Positive and Negative sUPP in Women With Urodynamic Stress Incontinence
- ClinicalTrials.gov ID
- NCT06783699
- Acronym / sponsor ID
- 202406048RINC
- Conditions
- Urodynamic Stress Incontinence
- Keywords
- Urodynamic stress incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged more than 20-year-old with lower urinary tract symptoms underwent urodynamic study and were diagnosed with urodynamic stress incontinence.
Key inclusion criteria (3 listed)
- >20 y/o
- Women with lower urinary tract symptoms
- Received urodynamic stress incontinence and was diagnosed with urodynamic stress incontinence
Key exclusion criteria (2 listed)
- Women who are pregnant
- With chronic pelvic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary incontinence in bladder diary
Time frame: Between July 2009 and December 2023
Subjective urinary incontinence described in bladder diary
1 secondary outcome
Pad weight
Time frame: Between July 2009 and December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Results publication: PubMed 34762173Wu 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.
- Results publication: PubMed 30943696Hsiao 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.
- Results publication: PubMed 23922866Hsiao 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.
- Results publication: PubMed 27917521Rosier 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.
- Results publication: PubMed 19941278Haylen 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.
- Individual participant dataSharing planned: No. Data will be shared under request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, M.D. Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urodynamic Stress Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence in bladder diary (time frame: Between July 2009 and December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783699, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.