Detrusor OveracitivityNCT06793046
Comparisons of Phasic and Terminal DO
An observational study of Detrusor Overacitivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Overactive bladder is a common issue among women of childbearing age, regardless of their childbirth experience. Some of these women may exhibit detrusor overactivity in urodynamic studies. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Detrusor Overacitivity
- How many people
- 290 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jul 2024to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women more than 20-year-old with lower urinary tract symptoms, received urodynamic study and was diagnosed with detrusor overactivity.
Who may be able to join
- > 20 y/o
- Women with lower urinary tract symptoms
- Complete urodynamic study with a diagnosis of detrusor overactivity
- Complete the questionnaires
Who cannot join
- Woman who was pregnant
- Chronic pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Phasic and Terminal Detrusor Overactivity in Women With Lower Urinary Tract Dysfunction
Overactive bladder is a common issue among women of childbearing age, regardless of their childbirth experience. Some of these women may exhibit detrusor overactivity in urodynamic studies. Excluding detrusor overactivity caused by neurogenic bladder, the International Continence Society defines two types of idiopathic detrusor overactivity: phasic and terminal. Although many studies have explored overactive bladder and detrusor overactivity under different conditions, no literature directly compares these two types of detrusor contractions. Therefore, we aim to compare phasic and terminal detrusor overactivity in women with lower urinary tract dysfunction. Between July 2009 and December 2023, medical records 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 detrusor overactivity were selected for comparison (N=290). Those with phasic and terminal detrusor overactivity were excluded (N=21).
Read the 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.
- Conditions
- Detrusor Overacitivity
- Keywords
- Detrusor overactivity
- Medical subject headings
- Urinary Bladder, Overactive
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 |
|---|---|---|
| Phasic DO | Detrusor involuntary contraction during filling cystometry before strong-desire to void volume | |
| Terminal DO | Detrusor involuntary contraction at the end of filling cystometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
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)
Measured: Between July 2009 and December 2023
Secondary outcomes (1)
Strong-desire to void volume (mL) in urodynamic study
Use urodynamic study to evaluate the bladder capacity of the 2 cohort
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 posted27 Jan 2025
- Study start17 Jul 2024
- Primary completion31 Aug 2024
- Study completion30 Sep 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 Detrusor OveracitivityStudies 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Ho-Hsiung Lin, M.D. Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793046
- Sponsor's protocol ID
- 202406143RINE
- Status last verified
- Jul 2024
- First submitted
- 14 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be provided under request.
Publications
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.
PubMed 30943696Wu 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 34762173Abrams 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.
PubMed 12559262Aoki 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.
PubMed 28681849Haylen 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Phasic and Terminal Detrusor Overactivity in Women With Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT06793046
- Acronym / sponsor ID
- 202406143RINE
- Conditions
- Detrusor Overacitivity
- Keywords
- Detrusor overactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 27 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.
Overactive bladder is a common issue among women of childbearing age, regardless of their childbirth experience. Some of these women may exhibit detrusor overactivity in urodynamic studies. Excluding detrusor overactivity caused by neurogenic bladder, the International Continence Society defines two types of idiopathic detrusor overactivity: phasic and terminal. Although many studies have explored overactive bladder and detrusor overactivity under different conditions, no literature directly compares these two types of detrusor contractions. Therefore, we aim to compare phasic and terminal detrusor overactivity in women with lower urinary tract dysfunction. Between July 2009 and December 2023, medical records 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 detrusor overactivity were selected for comparison (N=290). Those with phasic and terminal detrusor overactivity were excluded (N=21).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phasic DO | – | –Detrusor involuntary contraction during filling cystometry before strong-desire to void volume |
| Terminal DO | – | –Detrusor involuntary contraction at the end of filling cystometry |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women more than 20-year-old with lower urinary tract symptoms, received urodynamic study and was diagnosed with detrusor overactivity.
Key inclusion criteria (4 listed)
- > 20 y/o
- Women with lower urinary tract symptoms
- Complete urodynamic study with a diagnosis of detrusor overactivity
- Complete the questionnaires
Key exclusion criteria (2 listed)
- Woman who was pregnant
- 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
Life quality
Time frame: Between July 2009 and December 2023
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)
1 secondary outcome
Strong-desire to void volume (mL) in urodynamic study
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 10 Feb 2025.
- 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 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 12559262Abrams 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.
- Results publication: PubMed 28681849Aoki 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.
- 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. The data will be provided under request.
Related trials for Detrusor Overacitivity
Recruiting
Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury
Spinal Cord Injury, Detrusor Overacitivity
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 Detrusor Overacitivity, 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 4 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 10 Feb 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?
Life quality (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 NCT06793046, 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 10 Feb 2025.