Overactive Bladder SyndromeNCT01627145
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
A study testing Solifenacin in people with Overactive Bladder Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Solifenacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Jul 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patients within 18 years old to 99 years old with overactive bladder syndrome
Who cannot join
- unwilling or unable to perform testing procedure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
No 8, Chung-Shan South Road,
Taipei, Taiwan, 100
Ho-Hsiung Lin, MD, PhD, +88623123456 ext. 71557, hhlin@ntuh.gov.tw
Ho-Hsiung Lin, MD, PhD
About this study
Official title: Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympto
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Solifenacin
- Keywords
- overactive bladder syndrome, derusor overactivity, urodynamic studies, bladder oversensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Solifenacin 5 mg qd,
| Study group | Role | What they receive |
|---|---|---|
| antimuscariniz drug | Experimental | Not described Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of normalized urodynamic pattern after treatment
Measured: 12 weeks
Secondary outcomes (1)
The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627145
- Sponsor's protocol ID
- 201012024RC
- Status last verified
- Nov 2012
- First submitted
- 21 Jun 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympto
- ClinicalTrials.gov ID
- NCT01627145
- Acronym / sponsor ID
- 201012024RC
- Conditions
- Overactive Bladder Syndrome
- Keywords
- overactive bladder syndrome, derusor overactivity, urodynamic studies, bladder oversensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 25 Jun 2012 (estimated)
- 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.
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antimuscariniz drug | Experimental | Drug: Solifenacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients within 18 years old to 99 years old with overactive bladder syndrome
Key exclusion criteria (1 listed)
- unwilling or unable to perform testing procedure
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 |
|---|---|---|
| SolifenacinSolifenacin 5 mg qd, | Drug | antimuscariniz drug |
Primary outcome
The percentage of normalized urodynamic pattern after treatment
Time frame: 12 weeks
1 secondary outcome
The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin in people with Overactive Bladder Syndrome, 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: status not confirmed, as of the sponsor's last update on 15 Nov 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Hsiung Lin, PhD (+886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of normalized urodynamic pattern after treatment (time frame: 12 weeks). 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 15 Nov 2012.