Minimally Invasive Therapies

Minimally invasive therapies are designed to destroy excess prostate tissue using lasers, microwave energy, or other sources of energy with the goal of reducing prostate size. Reducing the size of the prostate can help reduce the mechanical obstruction of and pressure on the urethra, thereby relieving BPH symptoms. The most common minimally invasive therapies are:

Transurethral microwave thermotherapy (TUMT)

In these procedures, microwaves are delivered through a catheter to select portions of the prostate to achieve temperatures up to 45°C (111°F).4  The procedure can be performed on an outpatient basis without general anesthesia and takes ~1 hour.4 In most TUMT procedures, a cooling device is used to prevent urethral necrosis and sloughing.12  If a cooling device is not used, prolonged catheterization may be necessary after the procedure. Irritative BPH symptoms may persist for weeks and temporary urinary retention may occur.12 These procedures are effective in partially relieving symptoms in men with BPH. Approved devices include12:

  • Prostatron®
  • Targis™
  • CoreTherm™
  • ThermMatrx™

Precautions12:

  • Ensure that the patient meets the device’s indications, including criteria for eligible prostate sizes
  • Discuss risks and benefits of procedure with the patients, duration of the procedure, level of pain or discomfort, importance of telling physician about unusual pain during treatment
  • Inform patient of the need to remain as still as possible during the procedure
  • Ensure proper placement and condition of urethral catheter and rectal temperature sensor
  • Do not oversedate the patient as this will make it difficult for him to inform you of any unusual pain or heat
  • Do not use general or spinal anesthesia
  • Closely monitor patient and equipment throughout the procedure

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Transurethral Needle Ablation

This technique uses radiofrequency waves (490 kHz) administered through two 18-gauge needles at the tip of a catheter to heat prostate tissue up to 100°C. The needles have insulating sheaths to protect the urethra from heat damage. As with TUMT, irritative symptoms may persist for weeks and temporary urinary retention may occur. The TUNA procedure is appropriate for patients with obstructive BPH, prostate weight of ≤60, and enlargement primarily of the lateral lobes of the prostate.12
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Water-induced thermotherapy

In this technique, a catheter containing multiple shafts is inserted into the urethra such that a treatment balloon rests in the middle of the prostate. Heated water is then passed through the balloon and heats select areas of the surrounding prostate tissue. Tissue in the urethra and bladder is protected.4
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Treatment Issues

  • Patients usually have to wear a catheter for hours or days after minimally invasive procedures.12
  • Temporary urinary retention may occur in a significant portion of patients.12
  • Irritative voiding symptoms may persist for weeks.12

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References
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  2. RAPAFLO® (silodosin) Capsules full Prescribing Information, November 2009.
  3. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181:2634-2640.
  4. National Institute of Diabetes and Digestive and Kidney Diseases. Prostate enlargement: benign prostatic hyperplasia. NIH Publication No. 07-3012. June 2006.
  5. Bruskewitz RC. Quality of life and sexual function in patients with benign prostatic hyperplasia. Rev Urol. 2003;5:72-80.
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  9. Data on file, Watson Laboratories, Inc.
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  11. Agency for Healthcare Quality and Research (U.S. Dept Health and Human Services): Quick Tips When Talking With Your Doctor. Available at: http://www.ahrq.gov/consumer/quicktips/doctalk.htm. Accessed July 28, 2010.
  12. American Urological Association. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:530-547.
  13. Fagelman E, Lowe FC. Herbal medications in the treatment of benign prostatic hyperplasia (BPH). Urol Clin N Am. 2002;29:23-29, vii.
  14. National Institute on Aging: Talking With Your Doctor: A Guide For Older People. NIH Publication No. 05-3452. August 2005 (Reprinted April 2010). Available at: http://www.nia.nih.gov/NR/rdonlyres/90DF996C-DF5F-4245-B7CA-B2E1B993D8C7/0/TWYD_0521_web.pdf. Accessed July 29, 2010.
  15. Medline Plus Medical Encyclopedia from NIH: Enlarged Prostate. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000381.htm. Accessed July 29, 2010.
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  20. Ponholzer A, Madersbacher S. Lower urinary tract symptoms and erectile dysfunction; links for diagnosis, management and treatment. Int J Impot Res. 2007;19:544-550.
  21. MacDiarmid SA, Hill LA, Volinn W, Hoel G. Lack of pharmacodynamic interaction of silodosin, a highly selective α1a-adrenoceptor antagonist, with the phosphodiesterase-5 inhibitors sildenafil and tadalafil in healthy men. Urology. 2010;75:520-525.
  22. Marks LS. Reply to editorial comment. Urology. 2009;74:1323-1324.
  23. Schwinn DA, Roehrborn CG. α1-Adrenoceptor subtypes and lower urinary tract symptoms. Int J Urol. 2008;15:193-199.
  24. Straus SM, Kors JA, De Bruin ML, et al. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol. 2006;47:362-367.
  25. Carbone DJ, Hodges S. Medical therapy for benign prostatic hyperplasia: sexual dysfunction and impact on quality of life. Int J Impot Res. 2003;15:299-306.
  26. Nomiya M, Yamaguchi O. A quantitative analysis of mRNA expression of alpha 1 and beta-adrenoceptor subtypes and their functional roles in human normal and obstructed bladders. J Urol. 2003;170(2 Pt 1):649-653.
  27. Murata S, Taniguchi T, Takahashi M, et al. Tissue selectivity of KMD-3213, an α1-adrenoreceptor antagonist, in human prostate and vasculature. J Urol. 2000;164:578-583.
  28. Stafford-Smith M, Bartz R, Wilson K, et al. Alpha-adrenergic mRNA subtype expression in the human nasal turbinate. Can J Anesth. 2007;54:549-555.
  29. Wei JT, Calhoun E, Jacobsen SJ. Urologic Diseases in America Project: benign prostatic hyperplasia. J Urol. 2008;179(5 Suppl.):S75-S80.
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  31. Berry SJ, Coffey DS, Walsh PC, et al. The development of human benign prostatic hyperplasia with age. J Urol. 1984;132:474.
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RAPAFLO® is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO® is not indicated for the treatment of hypertension.

Important Safety Information

RAPAFLO® is contraindicated in patients with severe renal impairment (CCr <30 mL/min), severe hepatic impairment (Child-Pugh score ≥10), and with use of strong CYP3A4 inhibitors. Postural hypotension with or without symptoms (eg, dizziness) may develop when beginning treatment with RAPAFLO®. As with all alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrences of such events and should avoid situations where injury could result. RAPAFLO® should be used with caution in patients with moderate renal impairment. Patients should be assessed to rule out the presence of prostate cancer prior to starting treatment with RAPAFLO®. Patients planning cataract surgery should inform their ophthalmologist that they are taking RAPAFLO®.

The most common side effects are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.