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Treatment Options for Benign Prostatic Hyperplasia (BPH) How do you balance the challenges of providing a good in-office experience versus long-term symptom relief for your patients? What’s Your BPH Treatment Algorithm? Treating BPH • Minor symptoms usually do not require treatment. • Moderate to severe symptoms tend to interfere with sleep and daily activities and usually require treatment. Treatment Options Three categories • Drug therapy • In-office procedures • Surgical procedures Three Categories of Treatment Options Drug Therapy Office Procedure Surgical -blocker 5- reductase inhibitor Combination Radio Frequency High energy TUMT Low energy TUMT TURP TUIP PVP HoLAP Drug Therapy Advantages • No surgery • Effective for mild to moderate symptoms Drug Therapy Disadvantages • • • Lifelong commitment to therapy Effectiveness may decrease over time Drug therapy can cause multiple side effects – • Impotence, dizziness, headaches, fatigue, and decreased libido Must take a daily pill for the rest of your life to maintain symptom relief and costs approximately $1,000 per year http://www.drugstore.com, 2006. Drug Therapy • Alpha-blockers (-blockers) • 5-alpha Reductase Inhibitors (5- reductase inhibitors) -Blockers -Blockers make urination easier by relaxing smooth muscle tissue in the prostate and outlet of the bladder Brand / Generic Name Flomax® (tamsulosin) Hytrin® (terazosin) Cardura® (doxazosin) Uroxatral® (alfuzosin) Type Selective -blocker -blocker -blocker Selective -blocker Company Name Boehringer Ingelheim Abbott Laboratories Pfizer, Inc. Sanofi-Aventis -Blockers: Rationale and Sites of Action Rationale Possible Sites of Action • Blockade of motorsympathetic adrenergic nerve supply to the prostate reduces urethral pressure • Functional predominance of 1-adrenoreceptors in human prostatic muscle • Prostatic stroma • Detrusor, trigone, urethra • Ganglia • Spinal and/or supraspinal structures Andersson K-E et al. BJU Int. 2000, Caine M et al. Br J Urol. 1975. -Blockers • Act by relaxing smooth muscle cells of the prostate and bladder neck – Improve urine flow – Reduce bladder outlet obstruction • Two categories – Nonuroselective alpha-blockers • Hytrin® and Cardura® target the -1 adrenoreceptors in the prostate – Uroselective alpha blocker • Flomax® targets -1a adrenoreceptor • Uroxatral® achieves its uroselectivity by its ability to attain higher tissue concentration -Blockers Adverse effects may include • • • • • Dizziness Fatigue Postural hypotension Nasal congestion Abnormal ejaculation 5- Reductase Inhibitors 5- reductase inhibitors suppress blood flow and the accompanying hormones that stimulate prostate growth Brand / Generic Name Avodart® (dutasteride) Proscar® (finasteride) Type 5- Reductase Inhibitor 5- Reductase Inhibitor Company Name GlaxoSmith Kline Merck & Co., Inc. 5- Reductase Inhibitors Overview • Prevention of progression over time • Prostate volume decreases by approximately 20% through reduction of dihydrotestosterone (DHT) stimulation • Slower onset of action than with -blockers • Only used in men with prostate >40 g McConnell JD et al. N Engl J Med, 1998. Nickel JC et al. Urology, 1998. 5- Reductase Inhibitors • Inhibit production of the hormone DHT (DHT is involved with prostate enlargement) • Have two isoforms: type 1 and type 2 – Both are found in normal prostate – Activity of both is increased with BPH • Drug examples – Proscar® inhibits type 2 isoenzyme – Avodart® inhibits both type 1 and type 2 5- reductase isoenzymes 5- Reductase Inhibitors Adverse effects may include – Impotence – Decreased libido – Decreased ejaculate volume Hospital or Ambulatory Surgery Center Setting • Surgical – Transurethral Resection of the Prostate (TURP) • Greenlight PVP™ System • HoLAP Surgical – Transurethral Resection of the Prostate (TURP) • A urologist passes a thin tube through the urethra into the center of the prostate, then scrapes away tissue with an instrument inserted through the tube • Considered “Gold Standard” for treating BPH Surgical – Transurethral Resection of the Prostate (TURP) Advantages Disadvantages • Availability of long-term outcomes data • Good clinical results • Treats prostates <150 g • Low retreatment rate • Low mortality • Requires two to four days hospitalization • Requires general or spinal anesthesia • Potential surgical risks include: – – – – – Impotence Retrograde ejaculation Incontinence Infection Excessive blood loss Borth CS et al, Urology, 2001. Mebust WK et al, J Urol, 1989. Wagner JR et al, Semin Surg Oncol, 2000. GreenLight PVP™ • • • • Hospital-based procedure Requires general anesthesia Better for smaller prostates TURP-like results HoLAP • Holmium laser ablation of the prostate (HoLAP) • Performed as an outpatient procedure • Tissue ablation is roughly equivalent to GreenLight PVP™ • Versatility of performing across multiple specialties and treating other urology conditions including strictures, tumors and stones Office Procedures • Avoid the need to take daily medication • Avoid some of the risks and complications associated with surgery Office Procedures • Radio Frequency Therapy (PROSTIVA®) • Microwave Thermotherapy (TUMT) Office Procedure - TUMT • Microwaves used to heat and destroy excess prostate tissue • Procedure takes about one hour • Some require 2 to 14 days of catheterization which can result in urinary tract infection Office Procedure PROSTIVA® RF Therapy • Safe and effective • A single office visit, treatment of less than one hour • Fewer side effects and adverse events when compared to traditional surgical treatments • Covered by Medicare and Medicaid in all 50 states and many private insurance companies PROSTIVA® RF Therapy • Delivers low-level radio frequency energy into the middle of the prostate and relieves obstruction without causing damage to the urethra • Can be performed with a sedative and local anesthetic in a urologist’s office • Procedure takes less than one hour • Catheterization, if required, is zerotwo days on average • Intended for men over age 50 Indication for Use PROSTIVA® radio frequency therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3. PROSTIVA® RF Therapy System User Guide. What Side Effects are Associated with PROSTIVA® RF Therapy? • Possible side effects include: – – – – – – – – Obstruction Catheterization (for urinary retention) Bleeding/blood in urine Pain/discomfort Urgency to urinate Increased frequency of urination Urinary tract infection Patients may also experience a minor burning sensation when urinating for one to two weeks following the treatment • Compared to traditional surgical treatments, fewer side effects and adverse events PROSTIVA® RF Therapy System User Guide. Temperature Chart Prolieve, Prostatron, Thermatrx, Targis Instructions for Use. PROSTIVA RF Therapy System User Guide. References • • • • • • • • • • • • • http://www.drugstore.com. Accessed March 7, 2006. PROSTIVA® RF Therapy System User Guide. Safety information from System User Guide is available at www.prostiva.com. Hytrin, Flomax, Avodart, Proscar, Uroxatral prescribing information. Lepor H et al., Proscar Peak Flow rate from “The impact of medical therapy on bother due to symptoms, quality of life and global outcome, and factors predicting response,” J Urol, 1998. van Kerrebroeck P, Jardin A, van Cangh P, Laval K.U., "Long-term safety and efficacy of a once-daily formulation of alfuzosin 10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study,” Euro Urol 2002; 41:54-61. Caine M, Raz S, Zeigler M, “Adrenergic and cholinergic receptors in the human prostate, prostatic capsule and bladder neck,” Br J Urol, 1975;47:193-202. Andersson K-E, “Mode of action of a1-adrenoreceptor antagonists in the treatment of lower urinary tract symptoms,” BJU International, 2000;85(suppl 2):12-18. McConnell JD, Bruskewitz RC, Walsh P, et al., for the Finasteride Long-term Efficacy and Safety Study Group. “The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia,” N Engl J Med, 1998;338:557-563. Nickel JC, “Long-term implications of medical therapy on benign prostatic hyperplasia end points,” Urology, 1998;51(suppl 4A):50-57. Borth CS, Beiko DT, Nickel JC, “Impact of medical therapy on transurethral resection of the prostate: a decade of change,” Urology, 001;57:1082-1086. Debruyne FMJ, Djavan B, DeLaRosette J, et al., “Interventional therapy for benign prostatic hyperplasia. Benign Prostatic Hyperplasia. 5th International Consultation on Benign Prostatic Hyperplasia (BPH). Eds: Chatelain C, Denis L, Foo KT, et al. World Health Organization–International Union Against Cancer. Paris, France. June 25-28, 2000:397-421. Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC, for the Writing Committee. “Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients,” J Urol, 1989;141:243-247. Wagner JR, Russo P, “Urologic complications of major pelvic surgery,” Semin Surg Oncol, 2000;18:216-228. For more information about PROSTIVA® RF Therapy, call (800) 643-9099, x6000; or visit www.prostiva.com CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.