Advancements in Minimally Invasive Surgical Options for the Management of Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate affecting more than 40 million men in the United States with an associated prevalence that increases from 40% to 80% among men 50 to 70 years of age, respectively.^1,2 Progression of BPH leads to the subsequent development of lower urinary tract symptoms (LUTS), which most commonly include frequent urination accompanied by urgency and a weak urinary stream.³ Continued, chronic LUTS can have a significant impact on the quality of life for patients by causing a loss of sleep, reduced productivity, impaired sex life, social isolation, and clinical depression.¹

CONSIDERATIONS FOR EARLY INTERVENTION IN THE PATIENT CARE PATHWAY

Treatment options for BPH encompass a range of pharmacologic and surgical options. Studies have suggested that therapy failures may be a result of late treatment initiation, which could suggest that earlier intervention may be warranted for some patients.⁴ The establishment of a validated grading system for bladder trabeculation provides a useful method that may be helpful to identify patients who may benefit from an earlier intervention.^4,5 Within the current patient care pathway, there is an opportunity for the earlier identification of patients who may be candidates for surgical treatments. There may be an important window of opportunity for effective treatment by considering surgical interventions sooner in the decision-making process.

Pharmacotherapy options are a first-line approach for some patients, particularly in mild to moderate cases in which invasive surgical options are not appropriate. However, barriers to long-term management with pharmacotherapies include adherence challenges, treatment-related adverse effects, and limited effectiveness. Current data demonstrates that up to 70% of patients are nonadherent to their pharmacologic regimens. Moreover, up to 26% of patients discontinue their medications because of insufficient treatment efficacy or adverse effects, including sexual dysfunction, headaches, and dizziness.^2,6,7 Numerous large-scale studies have reported modest effects on LUTS with traditional medical treatment. Additionally, long-term use of pharmacotherapy for LUTS in patients with BPH at very high risk for disease progression has been shown to potentially mask progressive increases in post void residual (PVR) volume and lead to further deterioration of detrusor muscle function.⁸

Surgical interventions become the primary strategy when first-line pharmacologic treatments fail to improve symptoms or prevent progression of BPH, according to evidence-based recommendations from the 2021 American Urological Association (AUA).⁹ Transurethral resection of the prostate (TURP) has been a mainstay among surgical therapies for the past 6 decades.^6,10 Historically, TURP has been considered a standard for surgical treatment of BPH based on its demonstrated efficacy; however, it is associated with long-term complications. Ejaculatory dysfunction occurs in approximately 65% of patients with TURP.¹¹ TURP-related complications may also affect utilization, as only about 2% of patients with moderate to severe BPH elect to undergo these procedures.⁶

Compared with initiation of treatment with pharmacotherapy in the first-line, patients who are considered for surgical intervention have added considerations and risks. Patients who undergo surgery are older, as they have progressed or not achieved symptom resolution, patients are more anticoagulated, and present with an increased presence of comorbidities.⁸ Thus, it’s possible that a window of opportunity could be missed by not considering surgery earlier.

In recent years, technological advancements in surgical procedures have introduced minimally invasive surgical therapy (MIST) options, offering patients and clinicians an additional treatment path to consider (Table).^9,12-14 MISTs, which include the prostatic urethral lift (PUL) procedure, water vapor thermal therapy (WVTT), and robotic waterjet treatment (RWT), are associated with faster recovery times than traditional surgical options and may be ideal in treating LUTS in patients with BPH who are younger, sexually active, precluded from other surgical procedures, or have failed medical therapy.^1,15

The addition of several MISTs to the AUA guidelines offers patients and clinicians additional treatment avenues for the management of BPH, particularly for patients who may not require invasive surgery but for whom medical therapy has failed or those who wish to avoid long-term adverse effects associated with medical therapy. Consideration of patient preferences and a shared decision-making approach when selecting a treatment is increasingly important. Factors that may affect the patient experience include the preservation of sexual function and quickness of recovery from treatment. Also worth considering with respect to medications, TURP, and other invasive options, are long-term complications, adverse effects, and patient factors (eg, adherence, utilization rates, patient preference).

This article explores the data and utility of MISTs and their role in the treatment spectrum for BPH. It will also review the implications of the rapidly evolving treatment spectrum and the increased importance of shared decision making when making treatment decisions.

MINIMALLY INVASIVE SURGICAL TREATMENTS

The 2021 AUA guidelines provide evidence-based recommendations for several MISTs (Table). The PUL procedure using the UroLift system received a moderate recommendation for patients with LUTS or BPH, where prostate volume is 30 to 80 cc, excluding patients with a verified obstructed median lobe (OML). WVTT using the Rezum system was also given a moderate recommendation for patients with LUTS or BPH, where prostate volume is 30 to 80 cc, with the PUL recommendation excluding patients with a verified OML.⁹ Additionally, the guidelines conditionally recommend PUL and WVTT as treatment options to patients who wish to preserve erectile and ejaculatory function. RWT is another MIST that is included in the recent guidelines, with a conditional recommendation for patients with a prostate volume of 30 to 80 cc.

Prostatic Urethral Lift

The PUL procedure (UroLift system) is an office-based MIST that involves the transurethral installation of permanent, mechanical implants via endoscopic guidance to lift apart lateral lobes and relieve BPH-associated bladder outlet obstruction.^1,16 The UroLift system received FDA approval in 2013 for the treatment of symptoms due to urinary outflow obstruction secondary to BPH, including lateral and median lobe hyperplasia, in men 45 years of age or older with a prostate volume of 0 cc to 100 cc. Like other MISTs, the UroLift system was developed to address shortcomings with both medical treatment and traditional, more invasive surgical techniques such as TURP and simple proctectomies.¹ PUL offers a less invasive surgical treatment option for potentially underserved patients who are noncompliant or discontinue medical treatment.¹⁶

Many previous MISTs have utilized thermal energy to induce tissue necrosis and reabsorption to relieve urinary obstructions.¹ Because such techniques require tissue ablation, a significant amount of postoperative edema occurs, which can require a longer recovery time and/or period requiring catherization.¹ The UroLift system relieves prostate obstruction without cutting, heating, or removing any prostate tissue.^1,17 Consequently, PUL has been shown to provide more rapid relief of LUTS and a quicker recovery with mild to moderate perioperative adverse effects that typically resolve within 2 weeks, which allows patients to return to their normal routines with minimal downtime.^1,17,18

Evidence Supporting the Utility of PUL

Recovery rates and quality of the recovery are important considerations for patients in their overall care experience with a given surgical intervention. Findings from the BPH6 study provide evidence supporting that patients who underwent PUL when compared with TURP experienced significantly faster rates of recovery (82% vs 53% at 1 month, P = .008). Compared with TURP, fewer patients who received PUL intervention required catheterization for more than 24 hours (45% vs 74%), had a lower average number of days to discharge (1.0 vs 1.9 days), and experienced a faster return to preoperative activities (11 vs 17 days), respectively.¹¹ PUL has also been shown to preserve both erectile dysfunction and ejaculatory dysfunction, with BPH6 study data reporting significant improvements in average ejaculatory score at 12 months for patients receiving PUL (P = .03) vs significant decline in patients who received TURP (P <.0001).¹¹ Additionally, 2-year follow-up data from the BPH6 study further demonstrated a sustained effect in preserving ejaculatory function in 100% of patients who received the PUL procedure vs 66% of those who received TURP.¹⁹ A Cochrane analysis provides further validation for this observation, reporting a superior ability to preserve ejaculatory function for PUL relative to TURP (mean difference: 4.30; 95% CI, 2.17-6.43).²⁰

Several clinical trials, including 2 separate 5-year follow-up studies, offer additional insight regarding the clinical and practical utility of PUL. The results from the L.I.F.T Study were published in 2013, which demonstrated the efficacy of PUL in the treatment of BPH.¹⁸ This data was further validated in a 5-year, prospective, randomized, sham controlled, blinded study that investigated the safety and efficacy of the PUL procedure across 19 centers in the United States, Canada, and Australia.¹ The study included 206 patients with the following inclusion criteria: age 50 years or more, International Prostate Symptom Score (IPSS) 13 or higher, peak urinary flow rate (Q_max) 12 mL/s or less with a 125-mL voided volume, and a 30 to 80 cc volume prostate as measured via transrectal ultrasound.¹ Notably, patients with the presence of an OML or an active urinary tract infection were excluded from the study.¹ Primary endpoints were evaluated at 3, 12, 24, 36, 48, and 60 months and included the following: symptom response IPSS, quality of life (QOL) and BPH Impact Index (BPHII), Q_max, sexual function, and safety.¹

At the 3-month timepoint, all primary and secondary end points were achieved. 88% greater reduction in IPSS for PUL vs sham (PUL, –11.1 ± 7.7; sham -5.9 ± 7.7; P = .003) and greater improvement in QOL and Q_max for PUL vs sham (PUL, 4.28 ± 5.16; sham 1.98 ± 4.88; P = .005). Associated efficacy for IPSS, QOL, Q_max, and BPHII remained durable through 5 years with reported rates of 35%, 44%, 50%, and 47%, respectively.¹ Surgical retreatment following PUL occurred at an overall rate of 13.6% at 5 years (2% to 3% per year) with 4.3% of patients receiving additional implants and 9.3% undergoing TURP or laser ablation.¹ Over 5 years of patient follow up, sexual function remained preserved for all patients receiving PUL treatment with no significant decrease in erectile function (determined by the International Index of Erectile Function [IIEF] 5) or ejaculatory function (determined by the Male Sexual Health Questionnaire for Ejaculatory Dysfunction [MSHQ-EjD]).¹

There were no serious adverse effects of traditional BPH surgery, such as stress urinary incontinence and requirement for blood transfusion, reported in the study; the most common adverse effects during the first 3 months postprocedure were pelvic pain (6%), hematuria (4%), dysuria (9%), and incontinence (3%).¹ In regards to durability of PUL, rates of surgical retreatment at 5 years are higher (13.6%) relative to TURP (5.8% to 7%); however, retreatment rates associated with PUL are similar to those with other surgical interventions such as photoselective vaporization of the prostate (6.1% to 17.7%), transurethral microwave therapy (9% to 21%), and transurethral needle ablation (TUNA) (14% to 15%).¹ Investigators also reported the lowest rates of postprocedure catherization of any currently available BPH treatment.¹ This aligns with other findings demonstrating that 80% of patients did not need postoperative catherization, and for patients who did, catheter duration averaged 16 hours.²¹

Water Vapor Thermal Therapy

Water vapor thermal therapy, another MIST known as the Rezum System, harnesses the high energy potential of steam delivered through a cystoscopic probe to illicit local tissue cellular death.^17,22 The resultant prostatic cellular apoptosis and subsequent local tissue reabsorption effectively relieves LUTS and bladder outlet obstruction.^17,22 Like PUL, WVTT is a viable MIST option for eligible patients that allows for preservation of erectile and ejaculatory function and can be performed as an office or clinic-based intervention using local anesthesia.^16,23,24 A multicenter, randomized, controlled trial investigated the efficacy and safety of WVTT for the treatment of BPH. Investigators followed 197 patients over 12 months, including patients with a median lobe or elevated bladder neck.²⁵ Findings demonstrated an 8-point or greater improvement in IPSS in 74% of patients at 3 months, which was sustained for a period of 12 months.²⁵ Significant improvements in flow rates (Q_max) and QOL were also observed at 3 and 12 months with preserved erectile and ejaculatory function.²⁵ Unlike PUL, a high percentage (90.4%) of patients required catherization for an average of approximately 3 days; 68% of catheterizations were discretionary, and 32% were due to the patient’s inability to void prior to discharge.²⁵ Two patients also experienced 3 adverse events related to the procedure including extended urinary retention and hospitalization due to nausea.²⁵ Similarly, another study demonstrated an improvement in IPSS of 11.6 points at 12 months that was sustained over a 4-year period (10.1 points).²⁶ Data from this study further verified that WVTT preserved both erectile and ejaculatory function, with associated IIEF and MSHQ-EjD scores remaining constant and reported improvements in the ejaculatory bother score for 3 years.²⁶

Robotic Waterjet Treatment

RWT is a novel therapeutic option previously introduced in the 2019 AUA guidelines.²⁷ RWT employs the AquaBeam robotic system, which uses real-time ultrasonographic imaging, and robotically guided water jets for prostatic resection.²⁸ In contrast to other MISTs, RWT requires the use of general anesthesia, and therefore procedures cannot be conducted in an office-based setting.²⁹ A small, prospective, multicenter trial published in 2017 investigated the efficacy and safety for RWT in the treatment of LUTS/BPH in 21 patients.²⁸ Resulting data reported significant improvements in mean IPSS (16.2 points; P <.01), QOL (3.3 points; P <.01), Q_max (9.7 mL/s, P <.01), and PVR volume (89 mL, P <.01).^28,30 All patients were catheterized with removal occurring after day 1 for 20 of 21 patients.²⁸ Improvements in sexual function did show some improvement; however, the only statistically significant improvement was regarding sexual intercourse satisfaction.²⁸ When considering RWT, clinicians should take into consideration that long-term evidence regarding outcomes and retreatment rates remains limited relative to other MISTs.³¹

REAL-WORLD EVIDENCE AND THE IMPORTANCE OF THE PATIENT PERSPECTIVE

Given the variety of factors that affect treatment success, including the patient experience, understanding the real-world utility of BPH treatments can help to inform treatment decision-making. Although double-blinded, randomized, controlled trials (RCTs) provide the most reliable way to evaluate efficacy, they may not always reflect the real-world conditions of medical treatments, particularly for office-based procedures such as the majority of MISTs.⁶ In recent years, UroLift and Rezum have become more widely used than many previous MISTs and it can be helpful to compare data from RCTs with real-world studies to provide a more complete picture regarding the efficacy and utility of each therapy.⁶

Real-world data from a 2-year, multicenter, retrospective study evaluating PUL in 1415 patients in an office setting demonstrated similar efficacy and safety data relative to previous trials, with several notable findings favoring a real-world vs trial setting: fewer patients required removal of implants, and fewer patients required postoperative catherization (16% vs 20%).¹⁶ Notably, 83% of the patients with baseline urinary retention became catheter-free at 1 month, and a total of 87% of patients achieved catheter independence by the end of the study.¹⁶ Additionally, subgroup analyses across all cancer therapy cohorts reported symptom relief without an increase in postoperative adverse effects; this is favorable relative to TURP, which has reported increased rates of stress incontinence (18% to 70%).¹⁶ These results suggest that clinic- or office-based treatment using PUL may be associated with better outcomes relative to other treatment settings.¹⁶

WVTTs have also been evaluated in the real-world setting, including data published in a recent, retrospective review including 129 patients from a single office setting.³² Patients either had a Spanner Prostatic Stent placed or were catheterized post procedure, which were continued 2 to 5 weeks and 1 week, respectively.³² Findings showed a slightly lower IPSS improvement relative to the Rezum pilot and Rezum II trials, reporting an improvement of 11.6 vs 13.1 and 12.2, respectively.³² The greatest improvements were observed 91 to 180 days post procedure, with greater reductions reported for voiding symptoms vs storage symptoms (73.6% vs 48.6%, respectively).³² The most common adverse effect was urinary tract infection, which occurred at a higher rate than standard catheters (23.7% vs 14.6%); additionally, 14% of patients experienced episodes of urinary retention after catheter or Spanner removal, and 4 patients required an anesthesia event post procedurally.³² Sixty-four percent of patients responded in a follow-up survey, which demonstrated a mean procedural satisfaction of 4.2 out of 5, with 40% of patients reporting that they were very satisfied vs 10% very dissatisfied. Moreover, 86% of patients said they would recommend the procedure to a friend.³² Overall, real-world data from this study parallels data reported in previous RCTs and supports WVTT as a well-tolerated, viable option for BPH treatment.³²

Evaluating the Patient Experience: Head-to-Head Studies

In addition to these real-world studies evaluating PUL and WVTT individually, analysis of data from RCTs and real-world practice settings using WVTT and PUL has helped to shed further insight regarding the effectiveness, retreatment rates, and patient experience associated with these minimally invasive procedures. A head-to-head study published in 2020 followed outcomes in 53 patients who underwent treatment with either procedure.¹⁷ Resulting data demonstrated a significantly better IPSS and QOL outcome for the PUL group vs the WVTT group (8.6 vs 15.6, P = .001; 1.5 vs 2.5, P = .04, respectively).¹⁷ Catheterization rates were significantly higher for the WVTT group vs the PUL group (87% vs 57%; P = .03). The WVTT group reported significantly longer catheterization duration vs the PUL group (4.5 ± 3.8 days vs 1.2 ± 2.3 days; P = .0004). Additionally, a significantly greater percentage of patients in the WVTT group vs the PUL group reported interference with community activities (40% vs 12%; P = .04) and dissatisfaction with treatment results (22% vs 3%; P = .07).¹⁷

A recent meta-analysis also demonstrated higher rates of catheterization in patients receiving WVTT (55% to 100%) versus PUL (32% to 68%).³³ These observed differences may be due to the inherent nature of each procedure and the associated time to healing and relief of LUTS, as PUL does not require tissue ablation.¹⁷

Return Procedures and Retreatment

Additional real-world data of relevance to the patient experience include return and retreatment rates among the interventions available. Results from a real-world study evaluating retreatment and return procedures were recently presented at the 2021 AUA Annual Meeting (Figure). The rates of return procedures were lowest for PUL (17%) compared with WVTT (23%), GreenLight laser surgery (22%), and TURP (21%). Retreatment rates were similar for GreenLight laser surgery (5.2%), TURP (5.3%), and PUL (5.4%).³⁴

Lack of consensus for reporting retreatment associated with BPH treatment has led to a call for change in how the reintervention rate is defined, with some proposing a composite value and others suggesting an annual intervention rate that accounts for patients lost to follow-up.³⁵ BPH studies have historically suffered from a substantial number of patients lost to follow-up, which has prompted questions surrounding the best method for assessing treatment durability.^6,16 Evaluating study data using Intent to Treat and Per Protocol analysis, as conducted in the L.I.F.T. study, may be helpful in comparing outcomes between different clinical trials and improve information for clinical and shared decision making. Additionally, there is a lack of consensus regarding criteria for defining retreatment for BPH. TURP studies often report 10-year retreatment rates using retrospective vs prospective data and older clinical trials do not include medical therapy as a retreatment in the reported data.⁹ Recently, a large Canadian study evaluating 58,038 patients who received TURP over a period of roughly 5 years reported a surgical retreatment rate of 10.9%, however, continued use of BPH medications was strikingly much higher at 27%, which brings into question the current understanding regarding TURP-associated treatment durability.¹⁶

The Value of Shared Decision-Making

Given the increasing number of options for the treatment of BPH, as well as the variety of factors that may affect treatment success, emphasis should be given to the patient perspective in the treatment selection process. To that end, updates to the 2021 AUA guidelines place an emphasis on the importance of using a shared decision-making model, wherein clinicians discuss key treatment classes (eg, medical, minimally invasive, endourologic, open/robotic assisted surgery) and thoroughly review risks and benefits for all treatment options.³⁶ Through a shared decision-making process, patients can feel a sense of empowerment to make an informed decision on their treatment selection that is more likely to result in a higher level of satisfaction, better treatment adherence, improved quality of life, and less decisional regret.³⁷

CONCLUSIONS

For patients seeking to preserve sexual function, prefer to forego invasive surgery, or for whom medical therapies have failed, MISTs provide an alternative to traditional medical and surgical therapies, particularly for patients who may benefit from earlier surgical intervention. With the ability to fill unmet needs, MISTs also allow clinicians and patients greater flexibility when pursuing a shared decision toward optimal treatment. Finally, the addition of MISTs to the AUA guideline recommendations coupled with increasingly robust clinical trial data and real-world findings suggest that MISTs play an important role in the treatment landscape for BPH.

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