Definitions of the strength of the recommendations (standard, recommendation and option) are defined at the end of the "Major Recommendations" field.
Diagnostic Evaluation
The Panel decided that the diagnostic section of the 2003 Guideline required updating. After review of the recommendations for diagnosis published by the 2005 International Consultation of Urologic Diseases and reiterated in 2009 in an article by Abrams et al. (2009), the Panel unanimously agreed that the contents were valid and reflected "best practices." The diagnostic guidelines by Abrams et al. (2009) are revisited in Appendix A7 of the original guideline document. Two treatment algorithms, one on the basic management of lower urinary tract symptoms (LUTS) in men and one on the detailed management for persistent bothersome LUTS, were adapted for this Guideline and are included in Appendix A7 of the original guideline document.
Basic Management
Not Recommended: The routine measurement of serum creatinine levels is not indicated in the initial evaluation of men with LUTS secondary to benign prostatic hyperplasia (BPH). [Based on review of the data and Panel consensus]
Detailed Management
If storage symptoms predominate, an overactive bladder due to idiopathic detrusor overactivity is the most likely cause if there is no indication of bladder outlet obstruction (BOO) from flow study. The treatment options of lifestyle intervention (fluid intake alteration), behavioral modification and pharmacotherapy (anticholinergic drugs) should be discussed with the patient.
It is the expert opinion of the Panel that some patients may benefit using a combination of all three modalities. Should improvement be insufficient and symptoms severe, then newer modalities of treatment such as botulinum toxin and sacral neuromodulation can be considered.
The patient should be followed to assess treatment success or failure and possible adverse events according to the section on basic management above.
Treatment Alternatives
Standard: Information on the benefits and harms of treatment alternatives for LUTS secondary to BPH should be explained to patients with moderate to severe symptoms (American Urological Association Symptom Index [AUA-SI] score ≥8) who are bothered enough to consider therapy. [Based on Panel consensus]
Table. Treatment Alternatives for Patients with Moderate to Severe Symptoms of BPH
Watchful Waiting
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Medical Therapies
Alpha-blockers
- Alfuzosin
- Doxazosin
- Tamsulosin
- Terazosin
- Silodosin*
5-Alpha-reductase Inhibitors (5-ARIs)
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Combination Therapy
- Alpha blocker and 5-alpha-reductase inhibitor
- Alpha blocker and anticholinergics
Anticholinergic Agents
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Complementary and Alternative Medicines (CAM)
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Minimally Invasive Therapies
- Transurethral needle ablation (TUNA)
- Transurethral microwave thermotherapy (TUMT)
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Surgical Therapies
- Open prostatectomy
- Transurethral holmium laser ablation of the prostate (HoLAP)
- Transurethral holmium laser enucleation of the prostate (HoLEP)
- Holmium laser resection of the prostate (HoLRP)
- Photoselective vaporization of the prostate (PVP)
- Transurethral incision of the prostate (TUIP)
- Transurethral vaporization of the prostate (TUVP)
- Transurethral resection of the prostate (TURP)
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*Silodosin was approved by the U.S. Food and Drug Administration (FDA), but there were no published articles in the peer reviewed literature prior to the cut-off date for the literature search.
Watchful Waiting
Standard: Patients with mild symptoms of LUTS secondary to BPH (AUA-SI score <8) and patients with moderate or severe symptoms (AUA-SI score ≥8) who are not bothered by their LUTS should be managed using a strategy of watchful waiting (active surveillance). [Based on review of the data and Panel consensus]
Medical Management
Alpha-adrenergic Blockers (Alpha-blockers)
Option: Alfuzosin, doxazosin, tamsulosin, and terazosin are appropriate and effective treatment alternatives for patients with bothersome, moderate to severe LUTS secondary to BPH (AUA-SI score ≥8). Although there are slight differences in the adverse events profiles of these agents, all four appear to have equal clinical effectiveness. As stated in the 2003 Guideline, the effectiveness and efficacy of the four alpha blockers under consideration appear to be similar. Although studies directly comparing these agents are currently lacking, the available data support this contention.* [Based on review of the data and Panel consensus]
*Silodosin was approved by the FDA, but there were no relevant published articles in the peer-reviewed literature prior to the cut-off date for the literature search.
Option: The older, less costly, generic alpha blockers remain reasonable choices. These require dose titration and blood pressure monitoring. [Based on Panel consensus]
Recommendation: As prazosin and the nonselective alpha-blocker phenoxybenzamine were not reviewed in the course of this Guideline revision, the 2003 Guideline statement indicating that the data were insufficient to support a recommendation for the use of these two agents as treatment alternatives for LUTS secondary to BPH has been maintained. [Based on Panel consensus]
Option: The combination of an alpha-blocker and a 5-alpha reductase inhibitor (5-ARIs) (combination therapy) is an appropriate and effective treatment for patients with LUTS associated with demonstrable prostatic enlargement based on volume measurement, prostate-specific antigen (PSA) level as a proxy for volume, and/or enlargement on digital rectal exam (DRE). [Based on review of the data and Panel consensus]
Intraoperative Floppy Iris Syndrome
Recommendation: Men with LUTS secondary to BPH for whom alpha-blocker therapy is offered should be asked about planned cataract surgery. Men with planned cataract surgery should avoid the initiation of alpha-blockers until their cataract surgery is completed. [Based on review of the data and Panel consensus]
Recommendation: In men with no planned cataract surgery, there are insufficient data to recommend withholding or discontinuing alpha-blockers for bothersome LUTS secondary to BPH. [Based on review of the data and Panel consensus]
5-ARIs
Option: 5-ARIs may be used to prevent progression of LUTS secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgery. [Based on review of the data and Panel consensus]
Recommendation: 5-ARIs should not be used in men with LUTS secondary to BPH without prostatic enlargement. [Based on review of the data and Panel consensus]
Option: The 5-ARIs are appropriate and effective treatment alternatives for men with LUTS secondary to BPH who have demonstrable prostate enlargement. [Based on review of the data and Panel consensus]
5-ARIs for Other Indications
Hematuria
Option: Finasteride is an appropriate and effective treatment alternative in men with refractory hematuria presumably due to prostatic bleeding (i.e., after exclusion of any other causes of hematuria). A similar level of evidence concerning dutasteride was not reviewed; it is the expert opinion of the Panel that dutasteride likely functions in a similar fashion. [Based on review of the data and Panel consensus]
Prevention of Bleeding During Transurethral Resection of the Prostate (TURP)
Option: Overall, there is insufficient evidence to recommend using 5-ARIs preoperatively in the setting of a scheduled TURP to reduce intraoperative bleeding or reduce the need for blood transfusions. [Based on review of the data and Panel consensus]
Anticholinergic Agents
Option: Anticholinergic agents are appropriate and effective treatment alternatives for the management of LUTS secondary to BPH in men without an elevated post-void residual and when LUTS are predominantly irritative. [Based on Panel consensus]
Recommendation: Prior to initiation of anticholinergic therapy, baseline PVR urine should be assessed. Anticholinergics should be used with caution in patients with a post-void residual greater than 250 to 300 mL. [Based on Panel consensus]
Complementary and Alternative Medicines (CAM)
Recommendation: No dietary supplement, combination phytotherapeutic agent or other nonconventional therapy is recommended for the management of LUTS secondary to BPH. [Based on review of the data and Panel consensus]
Recommendation: At this time, the available data do not suggest that saw palmetto has a clinically meaningful effect on LUTS secondary to BPH. Further clinical trials are in progress and the results of these studies will elucidate the potential value of saw palmetto extracts in the management of patients with BPH. [Based on review of the data and Panel consensus]
Recommendation: The paucity of published high quality, single extract clinical trials of Urtica dioica do not provide a sufficient evidence base with which to recommend for or against its use for the treatment of LUTS secondary to BPH. [Based on review of the data and Panel consensus]
Minimally Invasive Therapies
Standard: Safety recommendations for the use of transurethral needle ablation of the prostate (TUNA) and transurethral microwave thermotherapy (TUMT) published by the FDA should be followed: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/default.htm . [Based on review of the data]
TUNA of the Prostate
Option: TUNA of the prostate is an appropriate and effective treatment alternative for bothersome moderate or severe LUTS secondary to BPH. [Based on review of the data and Panel consensus]
TUMT
Option: TUMT is effective in partially relieving LUTS secondary to BPH and may be considered in men with moderate or severe symptoms. [Based on review of the data and Panel consensus]
Surgical Procedures
Recommendation: Surgery is recommended for patients who have renal insufficiency secondary to BPH, who have recurrent UTIs, bladder stones or gross hematuria due to BPH, and those who have LUTS refractory to other therapies. The presence of a bladder diverticulum is not an absolute indication for surgery unless associated with recurrent UTI or progressive bladder dysfunction. [Based on review of the data and Panel consensus.]
Open Prostatectomy
Option: Open prostatectomy is an appropriate and effective treatment alternative for men with moderate to severe LUTS and/or who are significantly bothered by these symptoms. The choice of approach should be based on the patient's individual presentation including anatomy, the surgeon's experience, and discussion of the potential benefit and risks for complications. The Panel noted that there is usually a longer hospital stay and a larger loss of blood associated with open procedures. [Based on review of the data and Panel consensus.]
Laser Therapies
Option: Transurethral laser enucleation (holmium laser resection of the prostate [HoLRP], holmium laser enucleation of the prostate [HoLEP]), transurethral side firing laser ablation (holmium laser ablation of the prostate [HoLAP], and photoselective vaporization [PVP]) are appropriate and effective treatment alternatives to transurethral resection of the prostate and open prostatectomy in men with moderate to severe LUTS and/or those who are significantly bothered by these symptoms. The choice of approach should be based on the patient's presentation, anatomy, the surgeon's level of training and experience, and a discussion of the potential benefit and risks for complications. Generally, transurethral laser approaches have been associated with shorter catheterization time and length of stay, with comparable improvements in LUTS. There is a decreased risk of the perioperative complication of transurethral resection syndrome. Information concerning certain outcomes, including retreatment and urethral strictures, is limited due to short follow-up. As with all new devices, comparison of outcomes between studies should be considered cautiously given the rapid evolution in technologies and power levels. Emerging evidence suggests a possible role of transurethral enucleation and laser vaporization as options for men with very large prostates (>100 g). There are insufficient data on which to base comments on bleeding. [Based on review of the data and Panel consensus.]
Transurethral Incision of the Prostate (TUIP)
Option: TUIP is an appropriate and effective treatment alternative in men with moderate to severe LUTS and/or who are significantly bothered by these symptoms when prostate size is less than 30 mL. The choice of approach should be based on the patient's individual presentation including anatomy, the surgeon's experience and discussion of the potential benefits and risks for complications. [Based on review of the data and Panel consensus.]
Transurethral Electrovaporization of the Prostate (TUVP)
Option: TUVP is an appropriate and effective treatment alternative in men with moderate to severe LUTS and/or who are significantly bothered by these symptoms. The choice of approach should be based on the patient's individual presentation including anatomy, the surgeon's experience and discussion of the potential benefit and risks for complications. [Based on review of the data and Panel consensus.]
TURP
Option: TURP is an appropriate and effective primary alternative for surgical therapy in men with moderate to severe LUTS and/or who are significantly bothered by these symptoms. The choice of a monopolar or bipolar approach should be based on the patient's presentation, anatomy, the surgeon's experience and discussion of the potential risks and likely benefits. [Based on review of the data and Panel consensus]
Option: Overall, there is insufficient evidence to recommend using 5-ARIs in the setting of a pre-TURP to reduce intraoperative bleeding or reduce the need for blood transfusions. [Based on review of the data and Panel consensus]
Laparoscopic and Robotic Prostatectomy
Option: Men with moderate to severe LUTS and/or who are significantly bothered by these symptoms can consider a laparoscopic or robotic prostatectomy. There are insufficient published data on which to base a treatment recommendation. [Based on review of the data and Panel consensus]
Definitions:
Standard: A guideline statement is a standard if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions and (2) there is virtual unanimity about which intervention is preferred.
Recommendation: A guideline statement is a recommendation if: (1) the health outcomes of the alternative intervention are sufficiently well known to permit meaningful decisions, and (2) an appreciable but not unanimous majority agrees on which intervention is preferred.
Option: A guideline statement is an option if: (1) the health outcomes of the interventions are not sufficiently well known to permit meaningful decisions, or (2) preferences are unknown or equivocal. Options can exist because of insufficient evidence or because patient preferences are divided and may/should influence choices made.