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Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Primary Purpose

Lower Urinary Tract Symptoms, Bladder Outlet Obstruction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
solifenacin succinate
tamsulosin hydrochloride
Placebo to solifenacin
Placebo to tamsulosin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Bladder Outlet Obstruction, Treatment, Solifenacin Succinate, Tamsulosin hydrochloride

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

6 mg Solifenacin + 0.4 mg Tamsulosin

9 mg Solifenacin + 0.4 mg Tamsulosin

Arm Description

Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.

Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 25, 2007
Last Updated
July 14, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00507455
Brief Title
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
Keywords
Lower Urinary Tract Symptoms, Bladder Outlet Obstruction, Treatment, Solifenacin Succinate, Tamsulosin hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
Arm Title
6 mg Solifenacin + 0.4 mg Tamsulosin
Arm Type
Experimental
Arm Description
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
Arm Title
9 mg Solifenacin + 0.4 mg Tamsulosin
Arm Type
Experimental
Arm Description
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Other Intervention Name(s)
YM905, VESIcare
Intervention Description
Solifenacin succinate tablets
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride
Other Intervention Name(s)
Omnic Ocas, Flomax CR
Intervention Description
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Intervention Type
Drug
Intervention Name(s)
Placebo to solifenacin
Intervention Type
Drug
Intervention Name(s)
Placebo to tamsulosin
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Post Void Residual Volume (PVR)
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
Description
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.
Time Frame
Baseline and Week 12
Title
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Description
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.
Time Frame
From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Title
Change From Baseline in International Prostate Symptoms Score (IPSS)
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in IPSS Voiding Score
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in IPSS Storage Score
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in Number of Micturitions Per 24 Hours
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in Volume Voided Per Micturition
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8 and 12
Title
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Description
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.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
Description
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.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Description
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.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Description
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.
Time Frame
Baseline and Weeks 4, 8 and 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Kortrijk
Country
Belgium
City
Olomouc
Country
Czech Republic
City
Pilsen
Country
Czech Republic
City
Prague
Country
Czech Republic
City
Aachen
Country
Germany
City
Hagenow
Country
Germany
City
Landshut
Country
Germany
City
Muelheim
Country
Germany
City
Budapest
Country
Hungary
City
Szeged
Country
Hungary
City
Szekszard
Country
Hungary
City
Bialystok
Country
Poland
City
Myslowice
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22831853
Citation
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.
Results Reference
result

Learn more about this trial

Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

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