Lower Urinary Tract SymptomsPhase 2NCT00507455
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
A Phase 2 study testing solifenacin succinate and tamsulosin hydrochloride in people with Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, run by Astellas Pharma Inc at 33 sites in 6 countries.
Trial summary
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
- What is being tested?
- solifenacin succinate and tamsulosin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Jun 2007to Aug 2008
- Phase
- Phase 2
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
- BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
- Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
- Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.
Who cannot join
- History of urinary retention in preceding 12 months
- Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months.
- Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
- Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
- Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States17 sites
Study site
Austin, Texas, 78705
Study site
Charlottesville, Virginia, 22908
Study site
Coeur d'Alene, Idaho, 83814
Study site
Des Moines, Iowa, 50309
Study site
Greensboro, North Carolina, 27403
Study site
Homewood, Alabama, 35209
Study site
Iowa City, Iowa, 52242
Study site
La Mesa, California, 91942
Study site
Las Vegas, Nevada, 89148
Study site
Long Beach, California, 90806
Study site
Middlebury, Connecticut, 06762
Study site
New Port Richey, Florida, 34655
Study site
New York, New York, 10021
Study site
San Antonio, Texas, 78229
Study site
San Bernardino, California, 92404
Study site
San Diego, California, 92108
Study site
Watertown, Massachusetts, 02472
Germany4 sites
Study site
Aachen
Study site
Hagenow
Study site
Landshut
Study site
Mülheim
Poland4 sites
Study site
Bialystok
Study site
Mysłowice
Study site
Szczecin
Study site
Warsaw
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
- Being tested
- solifenacin succinate, tamsulosin hydrochloride, Placebo to solifenacin, Placebo to tamsulosin
- Keywords
- Lower Urinary Tract Symptoms, Bladder Outlet Obstruction, Treatment, Solifenacin Succinate, Tamsulosin hydrochloride
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinateDrug
Also called YM905, VESIcare
Solifenacin succinate tablets
tamsulosin hydrochlorideDrug
Also called Omnic Ocas, Flomax CR
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Placebo to solifenacinDrug
Placebo to tamsulosinDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. Receives: Drug: Placebo to solifenacin; Drug: Placebo to tamsulosin |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Experimental | Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. Receives: Drug: solifenacin succinate; Drug: tamsulosin hydrochloride |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Experimental | Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. Receives: Drug: solifenacin succinate; Drug: tamsulosin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.
Measured: Baseline and Week 12
Secondary outcomes (16)
Change From Baseline in Post Void Residual Volume (PVR)
Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.
End-of-treatment is the last post-baseline assessment during the treatment period.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:
BCI = pdetQmax + 5Qmax.
Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.
LS means were adjusted for pooled center and Baseline value.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:
Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.
A higher number indicates a higher voiding efficiency.
LS means were adjusted for pooled center and Baseline value.
Measured: Baseline and Week 12
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.
Measured: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Change From Baseline in International Prostate Symptoms Score (IPSS)
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:
- Sensation of incomplete emptying
- Repeat urinating after 2 hours (frequency)
- Start and stop several times (intermittency)
- Urgency
- Weak stream
- Straining
- Nocturia
Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in IPSS Voiding Score
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in IPSS Storage Score
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Micturitions Per 24 Hours
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Urgency Episodes Per 24 Hours
For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.
The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Volume Voided Per Micturition
The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 4, 8 and 12
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 4, 8 and 12
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 4, 8 and 12
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).
Least squares (LS) means were adjusted for pooled center and the Baseline value.
Measured: Baseline and Weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507455
- Sponsor's protocol ID
- 905-CL-058
- Other IDs
- 2007-001268-57
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2007
- Last updated
- 6 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.
PubMed 22831853
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
- ClinicalTrials.gov ID
- NCT00507455
- Acronym / sponsor ID
- 905-CL-058
- Keywords
- Lower Urinary Tract Symptoms, Bladder Outlet Obstruction, Treatment, Solifenacin Succinate, Tamsulosin hydrochloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to solifenacin, Drug: Placebo to tamsulosinParticipants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Experimental | Drug: solifenacin succinate, Drug: tamsulosin hydrochlorideParticipants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Experimental | Drug: solifenacin succinate, Drug: tamsulosin hydrochlorideParticipants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
- BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
- Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
- Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.
Key exclusion criteria (5 listed)
- History of urinary retention in preceding 12 months
- Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months.
- Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
- Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
- Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
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 succinateAlso: YM905, VESIcareSolifenacin succinate tablets | Drug | 6 mg Solifenacin + 0.4 mg Tamsulosin, 9 mg Solifenacin + 0.4 mg Tamsulosin |
| tamsulosin hydrochlorideAlso: Omnic Ocas, Flomax CRTamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets | Drug | 6 mg Solifenacin + 0.4 mg Tamsulosin, 9 mg Solifenacin + 0.4 mg Tamsulosin |
| Placebo to solifenacin | Drug | Placebo |
| Placebo to tamsulosin | Drug | Placebo |
Primary outcome
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Time frame: Baseline and Week 12
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Time frame: Baseline and Week 12
The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.
16 secondary outcomes
Change From Baseline in Post Void Residual Volume (PVR)
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
Time frame: Baseline and Week 12
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Time frame: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Change From Baseline in International Prostate Symptoms Score (IPSS)
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in IPSS Voiding Score
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in IPSS Storage Score
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Micturitions Per 24 Hours
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in Volume Voided Per Micturition
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Time frame: Baseline and Weeks 4, 8 and 12
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
Time frame: Baseline and Weeks 4, 8 and 12
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Time frame: Baseline and Weeks 4, 8 and 12
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Time frame: Baseline and Weeks 4, 8 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22831853Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solifenacin succinate and tamsulosin hydrochloride in people with Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, run by Astellas Pharma Inc at 33 sites in 6 countries.
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 5 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Poland, Czechia, Hungary and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 Aug 2014). 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 From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 NCT00507455, 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 6 Aug 2014.