American Urological Association -

advertisement

Home Guidelines Clinical Guidelines Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018)

Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (2018)

Published 2018

The goal of this revised guideline is to provide a useful reference on the effective evidence-based surgical management of male lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH).

Unabridged version of this guideline [pdf]
Algorithm associated with this guideline [pdf]
Access the 2010 guideline on Management of Benign Prostatic Hyperplasia

Panel Members

Harris E. Foster, MD; Michael J. Barry, MD; Manhar C. Gandhi, MD; Steven A. Kaplan, MD; Tobias S. Kohler, MD; Lori B. Lerner, MD; Deborah J. Lightner, MD; J. Kellogg Parsons, MD; Claus G. Roehrborn, MD; Charles Welliver, MD; Kevin T. McVary, MD.

Introduction

Purpose

Benign prostatic hyperplasia (BPH) is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and the severity of lower urinary tract symptoms (LUTS) in the aging male can be progressive and is an important diagnosis in the healthcare of patients and the welfare of society. In the management of bothersome LUTS, it is important that healthcare providers recognize the complex dynamics of the bladder, bladder neck, prostate, and urethra, in addition to the fact that symptoms may result from interactions of these organs as well as with the central nervous system or other systemic diseases (e.g., metabolic syndrome, congestive heart failure). Despite the more prevalent (and often first line) use of medical therapy for men suffering from LUTS attributed to BPH, there still remain clinical scenarios where surgery is indicated as the initial intervention for LUTS/BPH and should be recommended, providing other medical comorbidities do not preclude this approach. It is the hope that this revised guideline will provide a useful reference on the effective evidence-based surgical management of male LUTS secondary to BPH (LUTS/BPH). Please see the accompanying algorithm for a summary of the surgical procedures detailed in the guideline.

Methodology

The American Urological Association (AUA) Guideline: Management of Benign Prostatic Hyperplasia was last revised in 2010.1 In preparation for an update of the guideline, the Panel provided the Minnesota Evidence-based Practice Center with key questions, interventions, comparators, and outcomes to be addressed. The review team worked closely with the Panel to refine the scope, key questions, and inclusion/exclusion criteria. The key questions were divided into three topics: 1. Preoperative parameters that are necessary before surgical intervention is instituted, 2. Surgical management of bladder outlet obstruction (BOO) secondary to BPH, and 3. Acute urinary retention.

Panel Formation. The LUTS/BPH Panel was created in 2016 by the American Urological Association Education and Research, Inc. (AUAER). The Practice Guidelines Committee (PGC) of the AUA selected the Panel Chairs who in turn appointed the additional panel members with specific expertise in this area. The AUA conducted a thorough peer review process. The draft guideline document was distributed to 130 peer reviewers. The panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the guideline was submitted for approval to the PGC and Science and Quality Council (SQC) and subsequently to the AUA Board of Directors for final approval. Funding of the panel was provided by the AUA; panel members received no remuneration for their work.

Searches and Article Selection. The evidence review team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify randomized controlled trials (RCTs), clinical controlled trials (CCTs), systematic reviews/meta-analyses, and observational studies published and indexed between January 2007 and September 2017. Note, additional studies published outside of this date range may be included to inform background sections or provide historical context. A unique search strategy was used for each of the three topics. Systematic reviews and meta-analyses were searched to identify additional eligible studies. The review team also reviewed articles for inclusion identified by the Panel. Search terms included Medical Subject Headings (MeSH) and keywords for procedures, devices, and conditions related to LUTS or BPH. Limits were used to restrict the search to English language publications.

Abstract review was completed independently by two investigators to determine if citations were eligible for full text review. Two investigators independently reviewed full text articles to identify studies that met inclusion criteria. Conflicts between investigators on inclusion status were resolved through discussion or by a third investigator when necessary.

Risk of Bias (ROB) and Data Extraction. The review team used the Cochrane Collaboration's tool for assessing risk of bias (ROB).2 A bias is a systematic error in results or inferences that can lead to underestimation or overestimation of the true intervention effect. Differences in ROB can help explain heterogeneity in the results of studies included in a systematic review. ROB domains include random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Reviewers assessed ROB for the following outcomes: change in International Prostate Symptom Score (I-PSS), percent responders based on I-PSS (e.g., percentage achieving a minimally detectable difference [MDD] such as a 30-50% reduction in score from baseline or achieving an I-PSS score of ≤7 points following treatment), change from baseline in quality of life (I-PSS-QoL), perioperative adverse events, and other adverse events (e.g., symptom recurrence, need for reoperation). For blinding of outcome assessment and incomplete outcome data the review team assessed ROB for short-, intermediate-, and long-term follow-up. The overall ROB judgement for each outcome across domains was determined using an approach suggested in the Cochrane Handbook version 5.1.3 ROB was assessed by a single reviewer and quality checked by a subject expert. Discrepancies were resolved by consensus.

Data Synthesis and Analysis. Reviewers assessed clinical and methodological heterogeneity to determine appropriateness of pooling data. Data were analyzed in RevMan4 using DerSimonian-Laird random effects to calculate risk ratios (RR) with corresponding 95 percent confidence intervals (CI) for binary outcomes and weighted mean differences (WMD) with the corresponding 95 percent CIs for continuous outcomes. Statistical heterogeneity was assessed with the I2 statistic. If substantial heterogeneity was present (i.e., I2 ≥70%), reviewers stratified the results to assess treatment effects based on patient or study characteristics and/or explored sensitivity analyses. For I-PSS and I-PSS-QoL, reviewers determined the statistical significance of the effect of interventions versus control but defined clinical efficacy based on whether the mean or median effect between intervention and control exceeded thresholds for clinical significance (i.e., the MDD). For I-PSS this is a difference of > 3 points. For QoL reviewers defined this as greater than 1 point.

Overall quality of evidence for the primary outcomes within each comparison was evaluated using GRADEprobased on give assessed domains.6,7 The quality of evidence levels range from high to very low. The five domains include 1. Study limitations (ROB), 2. Directness (single, direct link between intervention and outcome), 3. Consistency (similarity of effect direction and size among studies), 4. Precision (degree of certainty around an estimate assessed in relationship to MDD), and 5. Reporting bias.

Determination of Evidence Strength. The categorization of evidence strength is conceptually distinct from the quality of individual studies. Evidence strength refers to the body of evidence available for a particular question and includes not only individual study quality but consideration of study design, consistency of findings across studies, adequacy of sample sizes, and generalizability of samples, settings, and treatments for the purposes of the guideline. The AUA categorizes body of evidence strength as Grade A (well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings), Grade B (RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings), or Grade C (RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data). By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty.

AUA Nomenclature: Linking Statement Type to Evidence Strength. The AUA nomenclature system explicitly links statement type to body of evidence strength, level of certainty, magnitude of benefit or risk/burdens, and the Panel's judgment regarding the balance between benefits and risks/burdens (See Table 1 below). Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial. Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate. Conditional Recommendations are non-directive statements used when the evidence indicates that there is no apparent net benefit or harm or when the balance between benefits and risks/burdens is unclear. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence. Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence is likely to change confidence. Body of evidence strength Grade C is only rarely used in support of a Strong Recommendation. Conditional Recommendations also can be supported by any evidence strength. When body of evidence strength is Grade A in support of a Conditional Recommendation, the statement indicates that benefits and risks/burdens appear balanced, the best action depends on patient circumstances, and future research is unlikely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual patient circumstances, and better evidence could change confidence. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.

Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinions with consensus achieved using a modified Delphi technique if differences of opinion emerged. A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature. Expert Opinion refers to a statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence.

TABLE 1: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength
 Evidence Strength A (High Certainty)Evidence Strength B (Moderate Certainty)Evidence Strength C (Low Certainty)
Strong Recommendation    (Net benefit or harm substantial)Benefits > Risks/Burdens (or vice versa) Net benefit (or net harm) is substantial Applies to most patients in most circumstances and future research is unlikely to change confidenceBenefits > Risks/Burdens (or vice versa) Net benefit (or net harm) is substantial Applies to most patients in most circumstances but better evidence could change confidence  Benefits > Risks/Burdens (or vice versa) Net benefit (or net harm) appears substantial Applies to most patients in most circumstances but better evidence is likely to change confidence (rarely used to support a Strong Recommendation)
Moderate Recommendation   (Net benefit or harm moderate)Benefits > Risks/Burdens (or vice versa) Net benefit (or net harm) is moderate Applies to most patients in most circumstances and future research is unlikely to change confidenceBenefits > Risks/Burdens (or vice versa) Net benefit (or net harm) is moderate Applies to most patients in most circumstances but better evidence could change confidenceBenefits > Risks/Burdens (or vice versa) Net benefit (or net harm) appears moderate Applies to most patients in most circumstances but better evidence is likely to change confidence
Conditional Recommendation   (No apparent net benefit or harm)Benefits = Risks/Burdens Best action depends on individual patient circumstances Future research unlikely to change confidenceBenefits = Risks/Burdens Best action appears to depend on individual patient circumstances Better evidence could change confidenceBalance between Benefits & Risks/Burdens unclear Alternative strategies may be equally reasonable Better evidence likely to change confidence
Clinical PrincipleA statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature
Expert OpinionA statement, achieved by consensus of the Panel, that is based on members clinical training, experience, knowledge, and judgment for which there is no evidence

Guideline Statements

Evaluation and Preoperative Testing

1. Clinicians should take a medical history and utilize the AUA-Symptom Index (AUA-SI) and urinalysis in the initial evaluation of patients presenting with bothersome LUTS possibly attributed to BPH; select patients may also require post-void residual (PVR), uroflowmetry, or pressure flow studies. (Clinical Principle)

2. Clinicians should consider assessment of prostate size and shape via abdominal or transrectal ultrasound, or cystoscopy, or by preexisting cross-sectional imaging (i.e. magnetic resonance imaging [MRI]/ computed tomography [CT]) prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

3. Clinicians should perform a PVR assessment prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

4. Clinicians should consider uroflowmetry prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

5. Clinicians should consider pressure flow studies prior to surgical intervention for LUTS attributed to BPH when diagnostic uncertainty exists. (Expert Opinion)

Surgical Therapy

6. Surgery is recommended for patients who have renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with LUTS attributed to BPH refractory to and/or unwilling to use other therapies. (Clinical Principle)

7. Clinicians should not perform surgery solely for the presence of an asymptomatic bladder diverticulum; however, evaluation for the presence of BOO should be considered. (Clinical Principle)

Transurethral Resection of the Prostate (TURP)

8. TURP should be offered as a treatment option for men with LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

9. Clinicians may use a monopolar or bipolar approach to TURP, depending on their expertise with these techniques. (Expert Opinion)

Simple Prostatectomy

10. Clinicians should consider open, laparoscopic or robotic assisted prostatectomy, depending on their expertise with these techniques, for patients with large prostates. (Moderate Recommendation; Evidence Level: Grade C)

Transurethral Incision of the Prostate (TUIP)

11. TUIP should be offered as an option for patients with prostates ≤30g for the surgical treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Transurethral Vaporization of the Prostate (TUVP)

12. Bipolar TUVP may be offered to patients for the treatment of LUTS attributed to BPH. (Conditional Recommendation; Evidence Level: Grade B)

Photoselective Vaporization of the Prostate (PVP)

13. Clinicians should consider PVP as an option using 120W or 180W platforms for patients for the treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Prostatic Urethral Lift (PUL)

14. Clinicians should consider PUL as an option for patients with LUTS attributed to BPH provided prostate volume <80g and verified absence of an obstructive middle lobe; however, patients should be informed that symptom reduction and flow rate improvement is less significant compared to TURP. (Moderate Recommendation; Evidence Level: Grade C)

15. PUL may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of with LUTS attributed to BPH. (Conditional Recommendation; Evidence Level: Grade C)

Transurethral Microwave Therapy (TUMT)

16. TUMT may be offered to patients with LUTS attributed to BPH; however, patients should be informed that surgical retreatment rates are higher compared to TURP. (Conditional Recommendation; Evidence Level: Grade C)

Water Vapor Thermal Therapy

17. Water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate volume <80g; however, patients should be informed that evidence of efficacy, including longer-term retreatment rates, remains limited. (Conditional Recommendation; Evidence Level: Grade C)

18. Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and ejaculatory function. (Conditional Recommendation; Evidence Level: Grade C)

Transurethral Needle Ablation (TUNA)

19. TUNA is not recommended for the treatment of LUTS attributed to BPH. (Expert Opinion)

Laser Enucleation

20. Clinicians should consider holmium laser enucleation of the prostate (HoLEP) or thulium laser enucleation of the prostate (ThuLEP), depending on their expertise with either technique, as prostate size-independent suitable options for the treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Prostate Artery Embolization (PAE)

21. PAE is not recommended for the treatment of LUTS attributed to BPH outside the context of a clinical trial. (Expert Opinion)

Medically Complicated Patients

22. HoLEP, PVP, and ThuLEP should be considered in patients who are at higher risk of bleeding, such as those on anti-coagulation drugs. (Expert Opinion)

Background

BPH is a histologic diagnosis that refers to the proliferation of glandular epithelial tissue, smooth muscle, and connection tissue within the prostatic transition zone, hence the term "stromo-glandular hyperplasia."8,9 While several hypotheses exist, BPH is likely the result of a multifactorial process, the exact etiology of which is unknown. It is clear that male androgenic steroid hormones testosterone and dihydrotestosterone (DHT) play at least a permissive role as the absence of these hormones prior to puberty prevents the development of BPH. BPH is nearly ubiquitous in the aging male with worldwide autopsy proven histological prevalence increases starting at age 40-45 years to reach 60% at age 60 and 80% at age 80.10

BPH or histological hyperplasia in itself does not require treatment and is not the target of therapeutic intervention. BPH does, however, in many men lead to an enlargement of the prostate called benign prostatic enlargement (BPE). The onset of the enlargement is highly variable as is the growth rate, though a 5% increase in volume has been shown in longitudinal studies of placebo treated patients.11 Clearly not all men with BPH will develop any evidence of BPE. The prostate gland may cause eventually obstruction at the level of the bladder neck, which in turned is termed benign prostatic obstruction (BPO), assuming a non-cancerous anatomy. It is important to realize that not all men with BPE will develop obstruction or BPO, just as not all men with BPH will have BPE. To complicate matters further, obstruction may also be caused by other conditions referred to as BOO. Thus, BPO is a subset of BOO.

Parallel to these anatomical and functional processes, LUTS increase in frequency and severity with age and are divided into those associated with storage of urine and with voiding or emptying. In addition, there are other symptoms following urination (e.g. post void dribbling).

Male LUTS may be caused by a variety of conditions, which include BPE and BPO. The enlarged gland has been proposed to contribute to the male LUTS complex via at least two routes: 1. Direct BOO/BPO from enlarged tissue (static component), and 2. From increased smooth muscle tone and resistance within the enlarged gland (dynamic component). This complex of storage symptoms is often referred to as overactive bladder (OAB). In men, OAB may be the result of primary detrusor overactivity/underactivity or develop secondary to the obstruction induced by BPE and BPO.12 

It is important to recognize that LUTS are non-specific, occur in men and women with similar frequency, and may be caused by many conditions, including BPE and BPO. Histological BPH is common and may lead to BPE. BPE may cause BPO, but not all men with BPH will develop BPE, and not all BPE will cause BPO. Because BPH is nearly ubiquitous and because LUTS in men is commonly associated with and/or caused by BPE/BPO, a compromise terminology is often used referring to "LUTS most likely associated with BPE/BPO and BPH" or "LUTS secondary to BPH." In this guideline, the Panel refers to "LUTS attributed to BPH" to indicate LUTS among older men for whom an alternative cause is not apparent after a basic evaluation. The Panel acknowledges that with a more extensive evaluation, some of these men will be found to have other conditions causing or contributing to their symptoms. As treatments being considered specifically for BPO become more invasive and risky, the importance of a more definitive diagnosis increases.

Lower Urinary Tract Symptoms (LUTS)

The prevalence and the severity of LUTS increases as men age and is an important diagnosis in the healthcare of patients and the welfare of society. In assessing the burden of disease, the Urologic Diseases in America BPH Project examined the prevalence of moderate-to-severe LUTS reported in U.S. population-based studies that used the definition of an AUA-SI score of ≥7.13 Results from the Olmsted County Study showed a progressive increase in the prevalence of moderate-to-severe LUTS, rising to nearly 50% by the eighth decade of life. The presence of moderate-to-severe LUTS was also associated with the development of acute urinary retention as a symptom of BPH progression, increasing from a prevalence of 6.8 episodes per 1,000 patient years of follow-up in the overall population to a high of 34.7 episodes in men aged 70 and older with moderate-to-severe LUTS. Another study has estimated that 90% of men between 45 and 80 years of age suffer some type of LUTS.14 Although LUTS/BPH is not often a life-threatening condition, the impact of LUTS/BPH on QoL can be significant and should not be underestimated.13 When the effect of BPH-associated LUTS on QoL was studied in a number of community-based populations, for many, the most important motivations for seeking treatment were the severity and the degree of bother associated with the symptoms. These were also important considerations when assessing BPH and deciding when treatment is indicated.15

Treatment of LUTS attributed to BPH

The main focus of this guideline is on the treatment of LUTS attributed to BPH utilizing common surgical techniques and minimally invasive surgical therapies (MIST), although some additional statements are made regarding specific pre-operative tests and their utility in identifying appropriate surgical candidates. To provide some reference to the clinical efficacy and side effect profile of the procedures discussed in this guideline, clinical statements are made in comparison to what is generally accepted as the gold standard, that being a TURP (monopolar and/or bipolar).

Traditionally, the primary goal of treatment has been to alleviate bothersome LUTS that result from BPO. More recently, treatment has also been focused on the alteration of disease progression and prevention of complications that can be associated with BPH/LUTS, such as acute urinary retention.16 A variety of pharmacologic classes of medications are employed to treat LUTS attributed to BPH, including alpha-adrenergic antagonists (alpha-blockers), beta adrenergic agonists, 5-alpha- reductase inhibitors (5-ARIs), anticholinergics, vasopressin analogs, PDE-5 inhibitors, and phytotherapeutics, which can be utilized alone or in combination to take advantage of their different mechanisms of action. Conversely, there exist clinical scenarios when either conservative management , including life style changes (e.g., fluid restriction, avoidance of substances with diuretic properties) or pharmacological management are either inadequate or inappropriate, warranting consideration of one of the many invasive procedures available for the treatment of LUTS attributed to BPH. Indications for the use of one of these modalities may include a desire by the patient to avoid taking a daily medication, failure of medical therapy to sufficiently ameliorate bothersome LUTS, and certain conditions that require more aggressive intervention where medical therapy is inappropriate. This latter category includes patients with acute and/or chronic renal insufficiency, refractory urinary retention, recurrent UTIs, and bladder stones or gross hematuria thought secondary to BPH.

Surgical treatment of symptomatic BPH has classically involved removal of the obstructing adenomatous tissue typically via the transurethral route (TURP) using monopolar electroconductivity. In instances where the physical size of the prostate precludes the ability to achieve this task safely utilizing TURP (i.e. risk of transurethral resection [TUR] syndrome resulting in dilutional hyponatremia/hypervolemia), open simple prostatectomy (OSP) (i.e. retropubic or suprapubic) has been the treatment of choice. These procedures generally require regional (spinal, epidural) or general anesthesia in addition to varying durations of hospital convalescence. Furthermore, as many patients who require surgery for BPH have concomitant medical conditions (e.g., history of coronary artery disease, cerebrovascular disease, deep vein thrombosis) that necessitate anticoagulation or antiplatelet therapy, use of TURP or OSP can present significant clinical challenges or in some cases may be contraindicated. In addition, known complications associated with TURP and open prostatectomy, such as intraoperative and perioperative bleeding requiring transfusion, urethral stricture, bladder neck contracture, stress urinary incontinence, erectile dysfunction (ED), and retrograde ejaculation (RE), can negatively impact QoL. For reasons including obviating the need for regional or general anesthesia, hospital stay, discontinuation of anticoagulation therapy, and open surgery, a variety of alternatives to the standard monopolar TURP have been developed and utilized to varying degrees in an attempt to achieve similar clinical efficacy and a reduction in short- and long-term complications. These alternative surgical treatments and MISTs either use modifications to existing technology used in TURP or utilize altogether new technologies and concepts. In this guideline, a decision was made to evaluate the commonly used surgical procedures and MISTs to treat LUTS attributed to BPH when indicated based on evaluation by an appropriately trained clinician. These procedures include monopolar and bipolar TURP, robotic simple prostatectomy (retropubic, suprapubic, and laparoscopic), TUIP, bipolar TUVP, PVP, PUL, thermal ablation using TUMT, water vapor thermal therapy, TUNA of the prostate, enucleation using HoLEP or ThuLEP, and PAE. Data utilized to generate these statements are based on the results from what the Panel felt were acceptably performed RCTs and CCTs comparing each technique to TURP.

Index Patient

For this guideline, the Index Patient  is a male aged 45 or older who is consulting a qualified clinician for his LUTS. He does not have a history suggesting non-BPH causes of LUTS, and his LUTS may or may not be associated with an enlarged prostate gland, BOO, or histological BPH.

Sexual Dysfunction and Surgical Therapy Data on the sexual side effects of BPH surgery can be difficult to ascertain as many studies are not primarily designed to answer this question. As such, many studies evaluate sexual side effects by looking at reported adverse events only, rather than specifically assessing sexual function. In addition, in some studies, especially those evaluating surgical treatments, patients may not only be undergoing a surgical procedure but are also stopping the previous medical therapy, which can confound interpretation of postoperative sexual function. Given the strong observed relationship between ED and LUTS/BPH, this group of men is at high risk for sexual dysfunction.17 Patients should be counselled about the sexual side effects of any surgical intervention and should be made aware that surgical treatment can cause ejaculatory dysfunction (EjD) and may worsen ED. Interventions for LUTS/BPH have clear sexual side effects. These treatments have a significant rate of EjD. Libido does not appear to be affected significantly by surgical therapy, and some studies have shown an improvement in erectile function (EF) after surgical treatment, although this improvement is controversial as other studies show a worsening of EF.18 Most importantly, sexual side effects from surgical treatments are more likely to be permanent than those from medical treatments, which can often be reversed by stopping medical treatment or switching to an alternative treatment.

Shared Decision Making

It is the hope that this clinical guideline will provide a useful reference on the effective evidence-based management of male LUTS attributed to BPH utilizing standard surgical techniques, MISTs using newer technologies, and treatments the Panel feels are investigative. This guideline also reviews a number of important aspects of the evaluation of LUTS, including available diagnostic tests to identify the underlying pathophysiology and to better assist in identifying appropriate candidates for invasive treatments. Certain treatment modalities recommended in the guideline may be unavailable to some clinicians, for example due to lack of access to the necessary equipment/technology or a lack of expertise in the use of such modalities. In such instances, clinicians should discuss the key treatment classes with patients and engage in a shared decision making approach to reach a treatment choice, which may necessitate a referral to another clinician for the chosen treatment. In all instances, patients should be provided with the risk/benefit profile for all treatment options in light of their circumstances to allow them to make informed decisions regarding their treatment plans.

Evaluation and Preoperative Testing

Guideline Statement 1

1. Clinicians should take a medical history and utilize the AUA-Symptom Index (AUA-SI) and urinalysis in the initial evaluation of patients presenting with bothersome LUTS possibly attributed to BPH; select patients may also require post-void residual (PVR), uroflowmetry, or pressure flow studies. (Clinical Principle)

Discussion


Guideline Statement 2

2. Clinicians should consider assessment of prostate size and shape via abdominal or transrectal ultrasound, or cystoscopy, or by preexisting cross-sectional imaging (i.e. magnetic resonance imaging [MRI]/ computed tomography [CT]) prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

Discussion


Guideline Statement 3

3. Clinicians should perform a PVR assessment prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

Discussion


Guideline Statement 4

4. Clinicians should consider uroflowmetry prior to surgical intervention for LUTS attributed to BPH. (Clinical Principle)

Discussion


Guideline Statement 5

5. Clinicians should consider pressure flow studies prior to surgical intervention for LUTS attributed to BPH when diagnostic uncertainty exists. (Expert Opinion)

Discussion


Surgical Therapy

Guideline Statement 6

6. Surgery is recommended for patients who have renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with LUTS attributed to BPH refractory to and/or unwilling to use other therapies. (Clinical Principle)

Discussion


Guideline Statement 7

7. Clinicians should not perform surgery solely for the presence of an asymptomatic bladder diverticulum; however, evaluation for the presence of BOO should be considered. (Clinical Principle)

Discussion


Guideline Statement 8

Transurethral Resection of the Prostate (TURP)

8. TURP should be offered as a treatment option for men with LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 9

Transurethral Resection of the Prostate (TURP)

9. Clinicians may use a monopolar or bipolar approach to TURP, depending on their expertise with these techniques. (Expert Opinion)

Discussion


Guideline Statement 10

Simple Prostatectomy

10. Clinicians should consider open, laparoscopic or robotic assisted prostatectomy, depending on their expertise with these techniques, for patients with large prostates. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 11

Transurethral Incision of the Prostate (TUIP)

11. TUIP should be offered as an option for patients with prostates ≤30g for the surgical treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 12

Transurethral Vaporization of the Prostate (TUVP)

12. Bipolar TUVP may be offered to patients for the treatment of LUTS attributed to BPH. (Conditional Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 13

Photoselective Vaporization of the Prostate (PVP)

13. Clinicians should consider PVP as an option using 120W or 180W platforms for patients for the treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 14

Prostatic Urethral Lift (PUL)

14. Clinicians should consider PUL as an option for patients with LUTS attributed to BPH provided prostate volume <80g and verified absence of an obstructive middle lobe; however, patients should be informed that symptom reduction and flow rate improvement is less significant compared to TURP. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 15

Prostatic Urethral Lift (PUL)

15. PUL may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of with LUTS attributed to BPH. (Conditional Recommendation; Evidence Level: Grade C) 

Discussion


Guideline Statement 16

Transurethral Microwave Therapy (TUMT)

16. TUMT may be offered to patients with LUTS attributed to BPH; however, patients should be informed that surgical retreatment rates are higher compared to TURP. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 17

Water Vapor Thermal Therapy

17. Water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate volume <80g; however, patients should be informed that evidence of efficacy, including longer-term retreatment rates, remains limited. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 18

Water Vapor Thermal Therapy

18. Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and ejaculatory function. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 19

Transurethral Needle Ablation (TUNA)

19. TUNA is not recommended for the treatment of LUTS attributed to BPH. (Expert Opinion)

Discussion


Guideline Statement 20

Laser Enucleation

20. Clinicians should consider holmium laser enucleation of the prostate (HoLEP) or thulium laser enucleation of the prostate (ThuLEP), depending on their expertise with either technique, as prostate size-independent suitable options for the treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 21

Prostate Artery Embolization (PAE)

21. PAE is not recommended for the treatment of LUTS attributed to BPH outside the context of a clinical trial. (Expert Opinion)

Discussion


Medically Complicated Patients

Guideline Statement 22

22. HoLEP, PVP, and ThuLEP should be considered in patients who are at higher risk of bleeding, such as those on anti-coagulation drugs. (Expert Opinion)

Discussion


Future Directions

BPH and ensuing LUTS is a significant health issue affecting millions of men. There are enormous gaps in knowledge and, therefore, ensuing opportunities for discovery. These include but are not limited to many unanswered questions, such as the role of inflammation, metabolic dysfunction, obesity, and environmental factors in etiology, as well as the role of behavior modification, self management, and evolving therapeutic algorithms in both the prevention and progression of disease.

Disease Etiology

Currently, there are few animal and human tissue models for BPH/LUTS. This limits the ability and efforts to understand both pathogenesis and progression. More specifically, computational biology and genomic factors should be aimed towards understanding drivers of BPH and prostate growth and therapeutic targets.

LUTS are differentially bothersome. Moreover, qualitative rather than quantitative changes have not been well described. For example, the most prevalent and bothersome of the LUTS is nocturia. The differential diagnosis of increased nighttime urination frequency/volumes and the role of sleep apnea is an area of great importance given that nocturia is also associated with increases in overall mortality. Enhanced metrics including bother, pain, and incontinence will need to be incorporate and evaluated.

Management of Nocturia

Due to the considerable burden of nocturia on QoL and a lack of effective management options, more funded research is needed. Nocturia is often multifactorial in origin and symptomatic of other medical problems, further complicating effective management. Nocturia, whether global, reduced bladder capacity, or mixed, is a unique symptom complex requiring special concern and judicious evaluation.

Urodynamic Evaluation and Imaging

The natural history and predictive ability of various urodynamic measures, such as flow rate and PVR, in regards to predicting patient reported outcomes (e.g., symptoms, QoL), and objective outcomes (e.g., peak flow, development of total retention, need for retreatment) is an area of great interest with substantial clinical and health care economic consequences.

The importance of prostate imaging and, specifically, the presence of an intravesical or obstructing lobe in determining natural history and treatment responses are of great clinical importance to make the best therapeutic decisions.

New Therapeutic Options

At the time of writing these guidelines there were many promising MISTs in development. It is the hope of this Panel that further data will be available in the peer reviewed literature on these therapies to allow incorporation into future iterations of this guideline. With so many MISTs being developed for LUTS/BPH, the Panel is compelled to consider the attributes to which successful MISTs should include characteristics for patients and urologists. Future MISTs should strive for novel therapies that approach standard technologies in outcomes, ideally providing effective therapy with fewer side effects.

From the patient standpoint, the hallmarks of a successful MIST might include the following: 1. Tolerability, 2. Rapid and durable relief of symptoms, 3. Short recovery time with rapid return to life activities, 4. Minimal adverse events, and 5. Affordability. In addition to addressing the patients' concerns, urologists strive for the following in looking to future therapies: 1. Capacity for performance in an ambulatory setting under reduced anesthesia, 2. A fast learning curve, 3. Generalizability from RCT, and 4. Ease of performance.

Traditionally, the primary goal of treatment has been to alleviate bothersome LUTS that result from BOO. While a MIST may not alleviate symptoms to the same degree or durability as more invasive surgical options, a more favorable risk profile and reduced anesthetic risk would make such a treatment attractive to many patients and providers. Since many men discontinue medical therapy, yet proportionately few seek surgery, there is a large clinical need for an effective treatment that is less invasive than surgery. With this treatment class, perhaps a significant portion of men with BOO who have stopped medical therapy can be treated prior to impending bladder dysfunction.

Treatment Failure

Surgical studies often underestimate treatment failure. In large part, these studies are reported as per protocol analyses versus intent to treat. Therefore, results focus on responders. Ensuing underassessment of surgical follow up (e.g., need for retreatment, re-medication) is an assessment gap that can result in an incomplete assessment of safety and efficacy of both office and surgical procedures.

Treatment Comparative Efficacy

Studies of comparative efficacy of behavioral and lifestyle intervention versus medical treatment and medical therapies versus MISTs for male LUTS and BPH are lacking and would be of great benefit for all levels of providers and patients and perhaps result in cost savings. Models could include population science, the development of registries and analysis of electronic medical records and insurance databases.

References

References


Abbreviations

American Urological AssociationAUA
AUA-Symptom IndexAUA-SI
Benign Prostatic EnlargementBPE
Benign Prostatic HyperplasiaBPH
Benign Prostatic ObstructionBPO
Bipolar Transurethral EnucleationBTE
Bladder Outlet ObstructionBOO
Clinical Controlled TrialsCCT
Computed TomographyCT
Confidence IntervalCI
DihydrotestosteroneDHT
Ejaculatory DysfunctionEjD
Erectile DysfunctionED
Erectile FunctionEF
Holmium Laser Enucleation of the ProstateHoLEP
International Continence SocietyICS
International Prostate Symptom ScoreI-PSS
Low Molecular Weight HeparinLMWH
Lower Urinary Tract SymptomsLUTS
Magnetic Resonance ImagingMRI
Minimally Detectable DifferenceMDD
Minimally Invasive Surgical TherapiesMIST
Open Simple ProstatectomyOSP
Overactive BladderOAB
Photoselective Vaporization of the ProstatePVP
Post Void ResidualPVR
Prostate Artery EmbolizationPAE
Prostate Specific AntigenPSA
Prostatic Urethral LiftPUL
Quality of LifeQoL
Randomized Controlled TrialsRCT
Retrograde EjaculationRE
Risk of BiasROB
Risk RatioRR
Thulium Laser Enucleation of the ProstateThuLEP
Transurethral Bipolar VaporizationTUVis
Transurethral Incision of the ProstateTUIP
Transurethral Needle AblationTUNA
Transurethral Resection of the ProstateTURP
Transurethral UltrasoundTRUS
Transurethral Vaporization of the ProstateTUVP
Urinary Tract InfectionsUTI
Weighted Mean DifferenceWMD

 
 

advertisement

advertisement

The New AUAnet

Tips

Website Tip!

While viewing Guideline Statements on a desktop computer, use the left navigation to jump to different parts of the page.