Overactive BladderPhase 4NCT00884104
A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
A Phase 4 study testing Solifenacin in people with Overactive Bladder, run by KYU-SUNG LEE at 9 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Mar 2009to Dec 2010
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IPSS ≥ 12
- Symptoms of OAB as verified by the V8 (≥8)
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Mean urinary frequency ≥8 times/24 hours
- Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)
Who cannot join
- Treatment within the 14 days preceding treatment with any alpha blocker drugs
- A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Cheonju
Study site
Choongju
Study site
Daegu
Study site
Daejeon
Study site
Kangneung
Study site
Kwangju
Study site
Pusan
Study site
Seoul
Study site
Suwon
About this study
Official title: A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.
The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.
Read the detailed description
This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin
- Keywords
- Solifenacin, Tamsulosin, OAB
- 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.
SolifenacinDrug
Also called Vesicare
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1.tamsulosin + solifenacin | Experimental | Not described Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with "add-on" solifenacin treatment
Measured: Weeks of 12, 24 and 52 of combination therapy
Secondary outcomes (1)
Change from baseline in micturition efficacy parameters
Measured: Weeks of 12, 24 and 52 of combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- KYU-SUNG LEE
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor-investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, MD, Principal investigator, University School of Medicine, Kangnan-ku, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884104
- Sponsor's protocol ID
- SMK-3
- Status last verified
- Jan 2016
- First submitted
- 25 Mar 2009
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee HN, Lee KS, Kim JC, Chung BH, Kim CS, Lee JG, Kim DK, Park CH, Park JK, Hong SJ. Rate and associated factors of solifenacin add-on after tamsulosin monotherapy in men with voiding and storage lower urinary tract symptoms. Int J Clin Pract. 2015 Apr;69(4):444-53. doi: 10.1111/ijcp.12581. Epub 2014 Nov 1.
PubMed 25363606
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.
- ClinicalTrials.gov ID
- NCT00884104
- Acronym / sponsor ID
- SMK-3
- Conditions
- Overactive Bladder
- Keywords
- Solifenacin, Tamsulosin, OAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- KYU-SUNG LEEUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Apr 2009 (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.
The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.
Detailed description
This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1.tamsulosin + solifenacin | Experimental | Drug: Solifenacin |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IPSS ≥ 12
- Symptoms of OAB as verified by the V8 (≥8)
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
Key exclusion criteria (2 listed)
- Treatment within the 14 days preceding treatment with any alpha blocker drugs
- A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
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 |
|---|---|---|
| SolifenacinAlso: VesicareOral | Drug | 1.tamsulosin + solifenacin |
Primary outcome
Percentage of patients with "add-on" solifenacin treatment
Time frame: Weeks of 12, 24 and 52 of combination therapy
1 secondary outcome
Change from baseline in micturition efficacy parameters
Time frame: Weeks of 12, 24 and 52 of combination therapy
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 7 Jan 2016.
- Derived from this study: PubMed 25363606Lee HN, Lee KS, Kim JC, Chung BH, Kim CS, Lee JG, Kim DK, Park CH, Park JK, Hong SJ. Rate and associated factors of solifenacin add-on after tamsulosin monotherapy in men with voiding and storage lower urinary tract symptoms. Int J Clin Pract. 2015 Apr;69(4):444-53. doi: 10.1111/ijcp.12581. Epub 2014 Nov 1.
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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.
Kyu-Sung Lee, MD principal investigator
University School of Medicine, Kangnan-ku, Seoul, Korea
9 sites 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 in people with Overactive Bladder, run by KYU-SUNG LEE at 9 sites in South Korea.
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 5 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. 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?
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?
Percentage of patients with "add-on" solifenacin treatment (time frame: Weeks of 12, 24 and 52 of combination therapy). 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 NCT00884104, which also lists 1 linked publication.
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 Jan 2016.