Overactive BladderPhase 4NCT01533597
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)
A Phase 4 study testing Solifenacin and Solifenacin plus Tamsulosin in people with Overactive Bladder, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB). Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin and Solifenacin plus Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 20 ≤ and < 70 years
- History of OAB symptoms for ≥ 3 months
- International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
- An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
Who cannot join
- Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
- Any condition that would contraindicate their usage of anticholinergics or alpha blockers
- History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
- History of stress urinary incontinence or urinary retention
- History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
- Pregnant or nursing women
Show all 11Show fewer
- Current urinary tract infection
- Neurological bladder dysfunction
- Treatment with drugs that may interfere with CYP3A4 metabolic function
- Significant hepatic or renal disease
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
About this study
Official title: Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).
Read the detailed description
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.
The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.
Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin, Solifenacin plus Tamsulosin
- Keywords
- Overactive bladder, Solifenacin succinate, Tamsulosin
- 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
Solifenacin (5mg, qd, oral)
Solifenacin plus TamsulosinDrug
Also called Vesicare, Harnal
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin | Active comparator | Not described Receives: Drug: Solifenacin |
| Solifenacin plus Tamsulosin | Experimental | Not described Receives: Drug: Solifenacin plus Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Number of Micturition Episodes Per 24 Hours
Measured: at week 24 relative to baseline
Secondary outcomes (5)
Numeric Change of Urgency Episodes Per 24 Hours
Measured: at week 24 relative to baseline
Change in Total Score of OABSS
Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)
Measured: at week 24 relative to baseline
Change in Score of IPSS
Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.
Measured: at week 24 relative to baseline
Change of PVR
Change from baseline in Post-Void Residual (PVR) volume
Measured: at week 24 relative to baseline
Change of Qmax
maximal urinary flow rate (Qmax) assessed by uroflowmetry
Measured: at week 24 relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang-Woo Lee, MD, Soonchunhyang University Hospital
- Investigators
- Kwang Woo Lee, Ph.D, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533597
- Sponsor's protocol ID
- Bomnal study
- Status last verified
- Jan 2015
- First submitted
- 2 Feb 2012
- Last updated
- 27 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT01533597
- Acronym / sponsor ID
- Bomnal study
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Solifenacin succinate, Tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 27 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).
Detailed description
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.
The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.
Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin | Active comparator | Drug: Solifenacin |
| Solifenacin plus Tamsulosin | Experimental | Drug: Solifenacin plus Tamsulosin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female aged 20 ≤ and < 70 years
- History of OAB symptoms for ≥ 3 months
- International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
- An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
Key exclusion criteria (11 listed)
- Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
- Any condition that would contraindicate their usage of anticholinergics or alpha blockers
- History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
- History of stress urinary incontinence or urinary retention
- History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
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: VesicareSolifenacin (5mg, qd, oral) | Drug | Solifenacin |
| Solifenacin plus TamsulosinAlso: Vesicare, HarnalSolifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral) | Drug | Solifenacin plus Tamsulosin |
Primary outcome
Change in Mean Number of Micturition Episodes Per 24 Hours
Time frame: at week 24 relative to baseline
5 secondary outcomes
Numeric Change of Urgency Episodes Per 24 Hours
Time frame: at week 24 relative to baseline
Change in Total Score of OABSS
Time frame: at week 24 relative to baseline
Change in Score of IPSS
Time frame: at week 24 relative to baseline
Change of PVR
Time frame: at week 24 relative to baseline
Change of Qmax
Time frame: at week 24 relative to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kwang Woo Lee, Ph.D principal investigator
Soonchunhyang 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 and Solifenacin plus Tamsulosin in people with Overactive Bladder, run by Soonchunhyang University Hospital at 1 site 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 4 inclusion and 11 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 27 Jan 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 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?
Yes. Results are posted in the registry (first posted 27 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Number of Micturition Episodes Per 24 Hours (time frame: at week 24 relative to baseline). 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 27 Jan 2015.