Overactive Bladder SyndromePhase 4NCT01876186
Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients
A Phase 4 study testing Solifenacin for 12 weeks and Solifenacin for 24 weeks in people with Overactive Bladder Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Solifenacin for 12 weeks and Solifenacin for 24 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Women who have overactive bladder syndrome
Who cannot join
- Women who are less than 20 year-old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, 100
Ho-Hsiung Lin, MD, PhD, +886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw
Ho-Hsiung Lin, MD, PhD
About this study
Official title: Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study
To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.
Read the detailed description
Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.
The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Solifenacin for 12 weeks, Solifenacin for 24 weeks
- Keywords
- antimuscarinic treatment, urodynamic studies, nerve growth factor
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin for 12 weeksDrug
Also called Vesicare
Solifenacin 5 mg one a day for 12 weeks
Solifenacin for 24 weeksDrug
Also called Vesicare
Solifenacin 5 mg once a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin for 12 weeks group | Experimental | Solifenacin (5 mg qd) for 12 weeks Receives: Drug: Solifenacin for 12 weeks |
| Solifenacin for 24 weeks group | Active comparator | Solifenacin (5 mg qd) for 24 weeks Receives: Drug: Solifenacin for 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of normalized urodynamic findings
The rate of normalized urodynamic finding after antimuscarinics
Measured: 6 months
Secondary outcomes (3)
The cure rate of overactive bladder
The cure rate of overactive bladder after antimuscarinics
Measured: 24 weeks
The recurrence rate of overactive bladder
The recurrence rate of overactive bladder after antimuscarinics
Measured: 2.5 years
The difference of urine nerve growth factor level
The difference of urine nerve growth factor level after antimuscarinics
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876186
- Sponsor's protocol ID
- 201212143RINB
- Status last verified
- Jul 2015
- First submitted
- 10 Jun 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT01876186
- Acronym / sponsor ID
- 201212143RINB
- Conditions
- Overactive Bladder Syndrome
- Keywords
- antimuscarinic treatment, urodynamic studies, nerve growth factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jun 2013 (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.
To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.
Detailed description
Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.
The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin for 12 weeks group | Experimental | Drug: Solifenacin for 12 weeksSolifenacin (5 mg qd) for 12 weeks |
| Solifenacin for 24 weeks group | Active comparator | Drug: Solifenacin for 24 weeksSolifenacin (5 mg qd) for 24 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who have overactive bladder syndrome
Key exclusion criteria (1 listed)
- Women who are less than 20 year-old
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 |
|---|---|---|
| Solifenacin for 12 weeksAlso: VesicareSolifenacin 5 mg one a day for 12 weeks | Drug | Solifenacin for 12 weeks group |
| Solifenacin for 24 weeksAlso: VesicareSolifenacin 5 mg once a day for 24 weeks | Drug | Solifenacin for 24 weeks group |
Primary outcome
The rate of normalized urodynamic findings
Time frame: 6 months
The rate of normalized urodynamic finding after antimuscarinics
3 secondary outcomes
The cure rate of overactive bladder
Time frame: 24 weeks
The recurrence rate of overactive bladder
Time frame: 2.5 years
The difference of urine nerve growth factor level
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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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
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?
A Phase 4 study testing Solifenacin for 12 weeks and Solifenacin for 24 weeks 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 7 Jul 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD, 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 rate of normalized urodynamic findings (time frame: 6 months). 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 7 Jul 2015.