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Completed

NCT Number: NCT00507455

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

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).

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Key information

Conditions

Lower Urinary Tract Symptoms Bladder Outlet Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solifenacin succinate

Drug

Solifenacin succinate tablets

Other names: YM905, VESIcare

Tamsulosin Hydrochloride

Drug

Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets

Other names: Omnic Ocas, Flomax CR

Placebo to solifenacin

Drug

Placebo to tamsulosin

Drug

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change From Baseline in Post Void Residual Volume (PVR)

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  2. Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)

    Time frame: Baseline and Week 12

    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.

  3. Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)

    Time frame: Baseline and Week 12

    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.

  4. 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).

    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.

  5. Change From Baseline in International Prostate Symptoms Score (IPSS)

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  6. Change From Baseline in IPSS Voiding Score

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  7. Change From Baseline in IPSS Storage Score

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  8. Change From Baseline in Patient Perception of Bladder Condition (PPBC)

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  9. Change From Baseline in Number of Micturitions Per 24 Hours

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  10. Change From Baseline in Number of Urgency Episodes Per 24 Hours

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  11. Change From Baseline in Number of Incontinence Episodes Per 24 Hours

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  12. Change From Baseline in Volume Voided Per Micturition

    Time frame: Baseline and Weeks 2, 4, 8 and 12

    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.

  13. 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

    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.

  14. Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score

    Time frame: Baseline and Weeks 4, 8 and 12

    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.

  15. 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

    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.

  16. Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score

    Time frame: Baseline and Weeks 4, 8 and 12

    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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 26, 2007
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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