Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tadalafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1. Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study. Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2. Have had BPH-LUTS for greater than 6 months prior to Visit 1. Exclusion Criteria: Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. History of urethral obstruction due to stricture, valves, sclerosis, or tumor. Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis). History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. History of angina requiring treatment with nitrates. Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo tablet taken by mouth once a day for 12 weeks.<br>|
| Active Comparator: 2<br>tadalafil | Drug: Tadalafil<br>* 20 mg tadalafil tablet taken by mouth once a day for 12 weeks.<br>* Other names: IC351;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Qmax was measured during free-flow tests using a standard calibrated flow meter. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Qave was measured during free-flow tests using a standard calibrated flow meter. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies |  | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full). | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full). | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Qmax was measured duirng pressure-flow tests. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Qave was measured during pressure-flow tests. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Vcomp was defined as the volume of voided urine measured during pressure-flow tests. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Max Pdet was defined as the maximum detrusor pressure observed during voiding. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement). | Baseline and 12 weeks | 
| Presence of Involuntary Detrusor Contractions During Bladder Filling |  | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | 12 weeks | 
| Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | Laboratory tests that were statistically significant and clinically adverse would be reported for safety. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy