Phase 2
N=222
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Lower Urinary Tract Symptoms · Bladder Outlet Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT00507455 ↗Enrolled (actual)
222
Serious AEs
2.3%
Results posted
Aug 2014
Primary outcome: Primary: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) — -1.69; -7.84; -6.69 cmH2O
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- solifenacin succinate (Drug); tamsulosin hydrochloride (Drug); Placebo to solifenacin (Drug); Placebo to tamsulosin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) |
-1.69; -7.84; -6.69 | — |
| PRIMARY Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
0.17; 1.85; 2.35 | — |
| SECONDARY Change From Baseline in Post Void Residual Volume (PVR) |
-10.21; 16.78; 8.97; -7.86; 14.92; 9.65 | — |
| SECONDARY Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) |
-1.63; 1.84; 3.86 | — |
| SECONDARY Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) |
-0.67; -1.38; -3.79 | — |
| SECONDARY Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests |
29; 38; 37; 21; 21; 20 | — |
| SECONDARY Change From Baseline in International Prostate Symptoms Score (IPSS) |
-3.8; -4.5; -4.7; -5.3; -6.4; -6.2 | — |
| SECONDARY Change From Baseline in IPSS Voiding Score |
-2.2; -2.9; -2.6; -3.2; -3.8; -3.6 | — |
| SECONDARY Change From Baseline in IPSS Storage Score |
-1.5; -1.6; -2.1; -2.1; -2.6; -2.5 | — |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
-0.5; -0.3; -0.5; -0.7; -0.5; -0.9 | — |
| SECONDARY Change From Baseline in Number of Micturitions Per 24 Hours |
-0.44; -1.25; -1.19; -1.03; -1.32; -1.72 | — |
| SECONDARY Change From Baseline in Number of Urgency Episodes Per 24 Hours |
-0.59; -0.89; -0.95; -1.18; -1.39; -1.34 | — |
| SECONDARY Change From Baseline in Number of Incontinence Episodes Per 24 Hours |
-0.81; -1.45; -1.01; -1.00; -1.45; -0.81 | — |
| SECONDARY Change From Baseline in Volume Voided Per Micturition |
9.36; 31.46; 18.25; 10.40; 35.27; 30.34 | — |
| SECONDARY Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score |
-3.9; -4.5; -4.6; -5.5; -5.6; -5.8 | — |
| SECONDARY Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score |
-14.6; -11.0; -17.0; -20.7; -19.4; -20.7 | — |
| SECONDARY Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score |
-2.7; -2.4; -5.1; -3.6; -4.3; -6.7 | — |
| SECONDARY Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score |
-1.2; -1.2; -1.3; -1.7; -1.7; -1.8 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT00507455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.