Urinary Bladder, OveractiveNCT06210477
Association With Low Compliance Bladder in Women With LUTS
An observational study of Urinary Bladder, Overactive and Urinary Bladder Neck Obstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction, Pelvic Organ Prolapse
- What is being tested?
- medical treatment for lower urinary tract symptoms
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2024to 31 Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with lower urinary tract symptoms
Who may be able to join
- Urodynamic finding with low bladder compliance
Who cannot join
- Nil.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Comparisons of Clinical and Urodynamic Parameters and Persistence in the Treatment for Women With Different Types of Low Bladder Compliance
Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.
Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.
- Conditions
- Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction, Pelvic Organ Prolapse, Urinary Incontinence
- Being tested
- medical treatment for lower urinary tract symptoms
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction, Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical treatment for lower urinary tract symptomsDrug
Also called antimuscarinics
The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.
| Study group | Role | What they receive |
|---|---|---|
| Low compliance | Low urinary tract symptoms with low bladder compliance Receives: Drug: medical treatment for lower urinary tract symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder capacity (mL)
To compare the bladder capacity (mL) between the groups with and without low bladder compliance. The bladder capacity will be derived from the filling cystometry of urodynamic studies.
Measured: 1996/1/1~2021/12/31
Secondary outcomes (1)
Persistence rates of treatment (%)
To compare the persistence rates of treatment (%) between the groups with and without low bladder compliance. The persistent rate of treatment will be checked from outpatient medical records about prescription.
Measured: 1996/1/1~2021/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, MD, PhD, Principal investigator, Department of Obstetrics and Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210477
- Sponsor's protocol ID
- 202303086RINC
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Clinical and Urodynamic Parameters and Persistence in the Treatment for Women With Different Types of Low Bladder Compliance
- ClinicalTrials.gov ID
- NCT06210477
- Acronym / sponsor ID
- 202303086RINC
- Conditions
- Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction, Pelvic Organ Prolapse, Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jan 2024 (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.
Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.
Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low compliance | – | Drug: medical treatment for lower urinary tract symptomsLow urinary tract symptoms with low bladder compliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with lower urinary tract symptoms
Key inclusion criteria (1 listed)
- Urodynamic finding with low bladder compliance
Key exclusion criteria (1 listed)
- Nil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical treatment for lower urinary tract symptomsAlso: antimuscarinicsThe clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association. | Drug | Low compliance |
Primary outcome
Bladder capacity (mL)
Time frame: 1996/1/1~2021/12/31
To compare the bladder capacity (mL) between the groups with and without low bladder compliance. The bladder capacity will be derived from the filling cystometry of urodynamic studies.
1 secondary outcome
Persistence rates of treatment (%)
Time frame: 1996/1/1~2021/12/31
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 19 Feb 2025.
- Individual participant dataSharing planned: No
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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, MD, PhD principal investigator
Department of Obstetrics and Gynecology, 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 Urinary Bladder, Overactive and Urinary Bladder Neck Obstruction, 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 1 inclusion and 1 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 19 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?
Bladder capacity (mL) (time frame: 1996/1/1~2021/12/31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.