- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793046
Comparisons of Phasic and Terminal DO
Comparisons of Phasic and Terminal Detrusor Overactivity in Women with Lower Urinary Tract Dysfunction
Study Overview
Status
Conditions
Detailed Description
Hypothesis / aims of study Detrusor overactivity (DO) can be classified into phasic or terminal ones. However, to our knowledge, clinical and urodynamic differences between phasic or terminal DO have never been reported. Therefore, the objective of this study is to elucidate the above differences.
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, urgency severity scale, overactive bladder symptom score, urogenital distress inventory, incontinence impact questionnaire and King's health questionnaire, of all women with lower urinary tract symptoms who underwent urodynamic studies in the urogynecological department of a medical center were reviewed. The medical records of phasic or terminal DO were selected for comparison. Those with phasic and terminal DO were excluded.
STATA software was used for statistical analysis. Wilcoxon rank sum test or chi-square test were used for statistical analysis, as appropriate. A p < 0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 20 y/o
- Women with lower urinary tract symptoms
- Complete urodynamic study with a diagnosis of detrusor overactivity
- Complete the questionnaires
Exclusion Criteria:
- Woman who was pregnant
- Chronic pelvic inflammatory disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Phasic DO
Detrusor involuntary contraction during filling cystometry before strong-desire to void volume
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Terminal DO
Detrusor involuntary contraction at the end of filling cystometry
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Life quality
Time Frame: Between July 2009 and December 2023
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Use King's health questionnaire Question 2 to evaluate the life quality of the 2 cohort (score 1-4, higher score indicates worse life quality)
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Between July 2009 and December 2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strong-desire to void volume (mL) in urodynamic study
Time Frame: Between July 2009 and December 2023
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Use urodynamic study to evaluate the bladder capacity of the 2 cohort
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Between July 2009 and December 2023
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Collaborators and Investigators
Investigators
- Principal Investigator: Ho-Hsiung Lin, M.D. Ph.D, National Taiwan University Hospital
Publications and helpful links
General Publications
- 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.
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42. Erratum In: Nat Rev Dis Primers. 2017 Nov 16;3:17097. doi: 10.1038/nrdp.2017.97.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202406143RINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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