Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).
This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatic Lift | Active Comparator | Treatment with the UroLift System |
|
| Medication | Active Comparator | Treatment with Tamsulosin HCl 0.4mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroLift System | Device | Prostatic lift |
| |
| Tamsulosin Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Paired comparison of International Prostate Symptom Score (IPSS) percent change | The primary study analysis compares the change in BPH symptoms in the PUL Arm to the change in BPH symptoms in the MED Arm measured 3 months after BPH therapy initiation. This will be measure by International Prostate Symptom Score (IPSS) percent change. IPSS ranges from 0-35, healthier patients have lower scores than patients more effected by BPH symptoms. | 3 Months after Therapy Initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QoL) | The secondary analysis assesses the change in quality of life (QoL) due to urinary symptoms between the PUL and MED Arms measured 3 months after initiation of BPH therapy. This will be measured by change in QoL, ranging from 0-6. Healthier patients have lower scores than patients more effected by BPH symptoms. | 3 months after BPH Therapy Initiation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogers Mitchell | Contact | 805-403-7107 | rogers.mitchell@neotract.com |
| Name | Affiliation | Role |
|---|---|---|
| Claus Roehrborn, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neotract | Recruiting | Pleasanton | California | 94588 | United States |
Not provided
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Tamsulosin HCl 0.4mg |
|
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |