Clinical Trials Logo

Clinical Trial Summary

This study is for individuals electing to have GreenLight Photoselective Vaporization of the Prostate (PVP) to treat symptoms from an enlarged prostate gland. The purpose of this research study is to evaluate the safety and effectiveness of the medication dutasteride as compared to placebo (an inactive substance) for improving surgical and long-term outcomes of PVP. Dutasteride is approved by the United States Food and Drug Administration (FDA) for the treatment of symptoms from an enlarged prostate gland. The use of dutasteride to improve the outcomes of PVP is investigational. The study will last for approximately 15 months and will involve 6 visits.


Clinical Trial Description

The purpose of the study is to assess the effects of dutasteride on the outcomes and QoL of patients undergoing GreenLight Photoselective Vaporization of the Prostate. PVP is a growing, outpatient surgical treatment for BPH. The addition of dutasteride may potentially improve both the short and long term outcomes. Use peri-operatively may improve visibility during surgery, shorten operative time, lessen bleeding both intra and post-operatively and hasten post-op recovery. Continued use long-term (12 months following the procedure) may improve overall symptomatic scores as combination therapy with PVP. The addition of dutasteride to PVP may decrease the occasional occurrence of continued post-op irritative symptoms and lessen the likelihood of the need for re-catheterization with overall improvement in quality of life. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00274417
Study type Interventional
Source Urology of Virginia
Contact
Status Active, not recruiting
Phase N/A
Start date January 2006
Completion date May 2009

See also
  Status Clinical Trial Phase
Recruiting NCT04807296 - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP) N/A
Recruiting NCT05574244 - Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
Completed NCT03246880 - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients Phase 3
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Completed NCT02283684 - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT Phase 4
Completed NCT02206243 - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed NCT01438775 - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
Completed NCT01152190 - A Study in Benign Prostatic Hyperplasia Phase 3
Completed NCT01139762 - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms Phase 3
Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A