Overview of Benchtop Models for Comparison of Surgical Treatments for Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: Benign prostatic hyperplasia (BPH) is a disease of the lower urinary tract which often requires surgical treatment. Recently, there has been a deluge of new treatment options, rarely validated or compared to current treatments on a benchtop model. The purpose of this review is to examine the literature and report which benchtop models are currently being used, which therapies have been tested on them, and what outcomes are being studied on each model. RECENT FINDINGS: There are various benchtop models to choose from, each with their unique benefits and drawbacks. Perfused porcine kidney models are used to assess bleeding on the benchtop, ex-vivo human prostate helps to see specific interactions of devices with the prostatic tissue, and all other models have evaluated tissue ablation rates and depth of coagulation. There are currently no synthetic or non-animal tissues being used for this purpose, and surgical techniques such as enucleation, water-jet ablation, prostate stents, and water vapor thermal therapy have no representation in these benchtop tests. Benchtop testing serves an important role in the evaluation and comparison of surgical treatments for BPH. This testing allows these therapies to be objectively compared to one another, helping novel medical devices in their path to market and urologists make treatment decisions. Future directions may include further validation of the animal models currently being used and development of synthetic models which mimic the prostate on the benchtop.

Role of Bladder Functional Testing Prior to Surgeries for Benign Prostatic Obstruction.

PURPOSE OF REVIEW: There is no consensus on preoperative functional testing prior to surgeries for benign prostatic obstruction causing lower urinary tract symptoms (LUTS). RECENT FINDINGS: Surgical management offers definite benefits, but the results are not always satisfactory. The urodynamic study (UDS) is the gold standard for assessing bladder outlet obstruction (BOO) which is the best predictor of surgical success. Yet, it is not recommended by our urologic societies as standard testing prior to surgery. In this narrative review of the literature, we report recent findings and controversies regarding the benefits and downside of UDS, and the use of other less-invasive approaches to achieve this goal. The lack of strong evidence for or against performing UDS was surprising. Prospective UDS data may not predict surgical outcomes if there is no consensus on criteria that directs surgical intervention. However, confirming the presence of BOO and characterizing the bladder function to identify detrusor over- and underactivity may help counselling and setting patient's post-operative expectations. Urocuff, a non-invasive testing offers promising results to address this problem with a less-invasive assessment of BOO. We emphasize better pre-operative characterization of patients to confirm BOO and better define subgroups to improve surgical decision-making.

Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

Residency Surgical BPH Training Paradigms from MIST to HOLEP.

PURPOSE OF REVIEW: Benign prostatic hyperplasia (BPH) is a common medical condition of older men that often requires medical or surgical therapy. Surgical options for BPH have grown exponentially over the last two decades. The numerous options and/or lack of access to them can make it challenging for new trainees to gain proficiency. We examine the literature for available BPH surgical simulators, learning curves, and training pathways. RECENT FINDINGS: Each BPH surgical therapy has a learning curve which must be overcome. There is an abundance of TURP simulators which have shown face, content, and construct validity in the literature. Similarly, laser therapies have validated simulators. Newer technologies do have available simulators, but they have not been validated. There are strategies to improve learning and outcomes, such as having a structured training program. Simulators are available for BPH surgical procedures and some have been implemented in urology residencies. It is likely that such simulation may make urologists more facile on their learning curves for newer technologies. Further studies are needed. Future directions may include integration of simulator technology into training pathways that include surgical observation and proctorship.

Supraspinal Neural Changes in Men With Benign Prostatic Hyperplasia Undergoing Bladder Outlet Procedures: A Pilot Functional MRI Study.

OBJECTIVE: To explore brain activation patterns on functional MRI (fMRI) in men with BPH and BOO before and after outlet obstruction procedures. METHODS: Men age ≥45 who failed conservative BPH therapy planning to undergo BOO procedures were recruited. Eligible men underwent a concurrent fMRI/urodynamics testing before and 6 months after BOO procedure. fMRI images were obtained via 3 Tesla MRI. Significant blood-oxygen-level-dependent (BOLD) signal activated voxels (P <.05) were identified at strong desire to void and (attempt at) voiding initiation pre- and post-BOO procedure. RESULTS: Eleven men were enrolled, of which 7 men completed the baseline scan, and 4 men completed the 6-month follow-up scan. Baseline decreased BOLD activity was observed in right inferior frontal gyrus (IFG), bilateral insula, inferior frontal gyrus (IFG) and thalamus. Significant changes in BOLD signal activity following BOO procedures were observed in the insula, IFG, and cingulate cortices. CONCLUSIONS: This represents a pilot study evaluating cortical activity in men with BPH and BOO. Despite limitations we found important changes in supraspinal activity in men with BPH and BOO during filling and emptying phases at baseline and following BOO procedure, with the potential to improve our understanding of neuroplasticity secondary to BPH and BOO. This preliminary data may serve as the foundation for larger future trials.

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Characterization of a Novel Implant Intended to Expand and Reshape the Prostatic Urethra for the Treatment of Benign Prostatic Hyperplasia: A Pre-Clinical Feasibility Study in the Canine Model.

OBJECTIVE: To evaluate the safety, feasibility, and tissue response of a novel device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia, using the first-generation Urocross Expander System (Mercury Expander System). METHODS: The implant was deployed and retrieved using flexible cystoscope in 8 adult male canines, separated into three study arms by retrieval date (1-, 6-, and 12- months post-deployment). Cystoscopy and urethrograms verified implant position/diameter; bladder neck and external sphincter function/changes; prostatic tissue response; and implant condition. One-month post-retrieval, the prostate and surrounding tissue was sectioned and evaluated by a veterinary pathologist. RESULTS: All implants were successfully deployed in the prostatic urethra. Urethral width was increased (6.9 ± 1.8 mm to 10.2 ± 0.6 mm, P = .012) and preserved through the dwell period. Urethral length and sphincter diameters didn't significantly change. All subjects (n = 8) remained continent without obstruction or retention. Adverse events included incisional site bleeding (n = 2) and transient hematuria (n = 3). One implant migrated into the bladder and spontaneously repositioned into the prostatic urethra. Post-retrieval, explant surfaces demonstrated no tissue growth, encrustation or stone formation. Imaging revealed contact site erythema and indentation, but no stones, strictures, perforations, erosions, nor ulcerations. Histopathology revealed glandular acinar changes, inflammation, and fibrosis. CONCLUSION: The first generation of the Urocross Expander System demonstrated a favorable safety profile in the canine model. Changes in the prostatic urethra shape were noted with an increase in urethral width during the dwell period with minimal tissue changes. Further, the implant didn't demonstrate any encrustation, tissue growth or stone formation.

Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System.

PURPOSE: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. MATERIALS AND METHODS: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. RESULTS: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). CONCLUSIONS: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

Effectiveness of convective water vapor energy therapy versus prostatic urethral lift for symptomatic benign prostatic hyperplasia: a systematic review and indirect comparison.

PURPOSE: To synthesize the evidence from randomized controlled trials of prostatic urethral lift (PUL) and convective water vapor thermal energy therapy (WAVE) for minimally invasive treatment of men with benign prostatic hyperplasia. METHODS: A systematic search of databases was performed to identify trials comparing WAVE or PUL to either an active or sham surgery control in subjects with symptomatic benign prostatic obstruction. A controlled indirect treatment comparison based on the approach of Bucher was performed for outcomes including International Prostate Symptom Score and maximum urinary flow rate (Qmax). The durability of treatment response was assessed by life-table analysis of freedom from retreatment through 4 years. RESULTS: Two multicenter sham-controlled trials (Rezum II Study, NCT01912339: LIFT Study, NCT01294150) were identified. The trials employed a common sham procedure and were similar with respect to their designs and subjects' baseline characteristics. Comparisons on the treatment effect in excess of sham response found non-significant differences between WAVE and PUL for symptom score [mean difference (MD): - 1.7 points; 95% confidence interval (CI): - 4.8, 1.4] but Qmax improvements favored WAVE [MD: 3.4 ml/sec; CI: 1.2, 5.6]. The proportion free of retreatment through 4 years was 89.1% for WAVE versus 75.4% for PUL [log-rank P = 0.004]. CONCLUSIONS: PUL and WAVE provide similar subjective improvements but flow-rate improvement and durability of response seem greater for WAVE. The confirmation of these findings in a randomized trial is warranted.

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

Update: The Clinical Role of Vaginal Lasers for the Treatment of the Genitourinary Syndrome of Menopause.

OBJECTIVE: To educate providers on the emergence of vaginal lasers for the treatment of the genitourinary syndrome of menopause (GSM) and discuss the peer-reviewed literature regarding their use. MATERIALS AND METHODS: A search of literature databases (PubMed and Medline) was performed for publications in February 2020. Keywords included genitourinary syndrome of menopause, urinary incontinence, overactive bladder, urgency, urinary tract infections, atrophy, laser, and vaginal. We reviewed the available published literature, identifying articles, guidance, and society statements on the use vaginal laser therapies. RESULTS: The literature regarding vaginal laser therapy in the treatment of the GSM is primarily limited to prospective case series with small numbers and short-term follow-up. Nevertheless, these studies have demonstrated reductions in genitourinary syndrome of menopause symptoms. High quality data describing the safety, benefits, and appropriate use of vaginal laser therapy is lacking. CONCLUSION: Vaginal laser treatment for the GSM is of interest as it provides patients with a nonhormonal treatment option. Further research to better outline the indications, efficacy, safety, and applications of this technology is needed before supporting its universal use for the management of the GSM.

Water vapor thermal therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: Systematic review and meta-analysis.

BACKGROUND: Water vapor thermal therapy (WVTT) is a minimally invasive procedure for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). There are no known systematic reviews reporting the effectiveness and safety of this increasingly common BPH therapy. METHODS: We performed a systematic review and meta-analysis of studies utilizing WVTT for symptomatic BPH. The international prostate symptom score (IPSS), IPSS-quality of life (IPSS-QOL), BPH impact index (BPHII), and maximum flow rate (Qmax) were calculated as the weighted mean difference relative to baseline and reported in minimal clinically important difference (MCID) units. MCID thresholds were -3 for IPSS, -0.5 for IPSS-QOL, -0.5 for BPHII, and 2 mL/s for Qmax. The surgical retreatment rate was calculated using life-table methods. RESULTS: We identified 5 cohorts treated with WVTT from 4 studies (514 patients; 40% with median lobe obstruction) with 2 years median follow-up (range: 6 months to 4 years). The IPSS, IPSS-QOL, BPHII, and Qmax significantly improved at all intervals between 3 months and 4 years; this benefit ranged from 3.3 to 3.8 MCID units for IPSS, 3.9 to 4.6 MCID units for IPSS-QOL, 6.8 to 8.2 MCID units for BPHII, and 1.5 to 3.0 MCID units for Qmax. The surgical retreatment rate was 7.0% at 4 years of follow-up data. Most adverse events were nonserious and transient; dysuria, urinary retention, and urinary tract infection were most common. No cases of de novo erectile dysfunction occurred. CONCLUSIONS: WVTT provided improvement in BPH symptoms that exceeded established MCID thresholds, preserved sexual function, and was associated with low surgical retreatment rates over 4 years.

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results.

BACKGROUND: Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited. OBJECTIVE: To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. STUDY DESIGN: This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. RESULTS: No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. CONCLUSION: Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.

The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) and accompanying lower urinary tract symptoms (LUTS) sits in the top ten prominent and costly disease conditions in men over 50 years of age. In the United States it is the most common diagnosis made by urologists for men 45 to 74 years of age. Twenty percent of the population will reach 65 years of age or older by 2030, and those over 85 years will represent the fastest growing segment of our population. The prevalence of symptomatic BPH increases proportionally with the aging population. It is estimated that BPH now affects 6% of the male population worldwide. Moreover, in Canada, the estimated BPH prevalence is more than 1 million men aged 50 years and older. Among the various surgical treatments, Rezum water vapor thermal therapy has been developed as a unique, rapid and reproducible minimally invasive surgical treatment exhibiting safe and early effective relief of LUTS/BPH. The targeted prostate tissue ablation is amenable to all zones of the prostate including intravesical median lobes. We present our experiences with this technique, which can be quickly performed under local anesthesia in an office setting.

Perspective on the Rezum® System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy.

Convective radiofrequency (RF) water vapor thermal therapy is a minimally invasive office or outpatient procedure for the treatment of bothersome moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). It provides an option for patients seeking rapid and durable relief of urinary symptoms, improved quality of life, and preservation of sexual function as an alternative to long-term use of drugs and avoidance of the potential side effects of pharmaceuticals or invasive BPH surgery. The procedure is also applicable for the treatment of the median lobe or elevated bladder neck from central zone hyperplasia. This perspective presents a comprehensive overview of the Rezum® System convective RF thermal therapy device, the principles upon which it is based, the operative procedure, and the clinical evidence accrued to this point in time.

Evaluation of Surgical Outcomes with Photoselective GreenLight XPS Laser Vaporization of the Prostate in High Medical Risk Men with Benign Prostatic Enlargement: A Multicenter Study.

OBJECTIVE: To evaluate the safety and short-term outcomes of photoselective vaporization of the prostate (PVP) using GreenLight XPS™ in treatment of high medical risk (HMR) men. METHODS: A multicenter retrospective analysis of 941 men who underwent PVP between August 2010 and August 2014 was performed. Patients were considered HMR if they had an American Society of Anesthesiologists physical status score ≥3. Postoperative adverse events, unexpected postoperative medical provider visits after intervention, and functional urinary outcomes were examined. RESULTS: HMR men (n = 273) were older (mean age 72.3 ± 8.1 years vs 67.1 ± 9 years, p ≤ 0.01), had larger prostate volumes (82.8 ± 48.2 g vs 73.7 ± 49.4 g, p < 0.01), and were more likely to be on anticoagulant and antiplatelet medications (all p ≤ 0.01). Moreover, overall operative time (65 ± 35.1 minutes vs 53.9 ± 24.9 minutes), energy delivered (313.4 ± 207 kJ vs 258 ± 164 kJ), and energy density used (4.2 ± 3.8 kJ/g vs 3.8 ± 3 kJ/g) were greater in the HMR group (all p ≤ 0.05). Although HMR men were more often treated in a hospital setting (p ≤ 0.01), there were no differences in intraoperative adverse events. At 6 months, both groups had notable improvements from baseline for International Prostate Symptom Score, quality of life due to urinary symptoms, maximum urinary flow rate, postvoid residual urine volume, and prostate-specific antigen. Regarding safety, the two groups had comparable 90-day Clavien-Dindo complication rates, numbers of urgent care visits, and numbers of outpatient consultations. HMR men, however, had more hospital readmissions within 90 days postsurgery (3.7% vs 1.3%; p = 0.04). CONCLUSIONS: Despite older age, greater comorbidity, and significant use of anticoagulants, HMR men who undergo photoselective vaporization benefit from symptom improvement and show no clinical difference in adverse event profiles. GreenLight-XPS produces similar short-term outcomes in patients with significant comorbidities when compared with healthy patients.

Safety, Perioperative, and Early Functional Outcomes of Vapor Incision Technique Using the GreenLight XPS 180 W System: Direct Comparison with Photoselective Vaporization of the Prostate.

OBJECTIVES: To compare perioperative parameters, safety, and short-term functional outcomes between GreenLight 180 W-XPS photoselective vaporization of the prostate (PVP) and vapor incision technique (VIT). MATERIALS AND METHODS: A total of 956 men were treated at five high-volume centers in Canada and the United States between 2000 and 2014 for benign prostatic hyperplasia. Perioperative parameters, complications, and early functional outcomes were retrospectively compared. One-to-one propensity score matching was performed to adjust for baseline differences between treatment groups. Subgroup stratified comparative analysis was performed according to preoperative prostate volume 80 cc or less vs greater than 80 cc on transrectal ultrasound (259 and 185 patients, respectively). RESULTS: VIT allowed greater energy delivery and energy density, but operative time and laser time were longer with greater use of MoXy fibers when compared with PVP (all p < 0.05). Improvements in outcomes at 6 months, including International Prostate Symptom Score, quality of life score, and uroflowmetry parameters, were significantly greater after VIT when compared with baseline. VIT was associated with significantly greater 6-month prostate-specific antigen (PSA) reduction (63% vs 50%, p = 0.01). No differences in intraoperative complications were observed between treatment groups. CONCLUSION: VIT is safe and efficacious, providing greater improvements in functional outcomes and PSA reduction at 6 months in comparison with PVP. These results reflect the larger amount of adenoma removed. Yet, it is associated with longer operative time and greater use of MoXy fibers. Long-term follow-up is needed to accurately assess functional outcomes and retreatment rates.

180 W vs 120 W lithium triborate photoselective vaporization of the prostate for benign prostatic hyperplasia: a global, multicenter comparative analysis of perioperative treatment parameters.

OBJECTIVE: To evaluate the surgical performance of the new Greenlight XPS-180 W laser system (American Medical Systems, Minnetonka, MI) and the effect of prostate volume (PV), in comparison with the former HPS-120 W system, for the treatment of benign prostatic hyperplasia by photo-selective vaporization of the prostate. METHODS: Between July 2007 and March 2012, 1809 patients underwent laser photo-selective vaporization of the prostate (1187 patients with the use of HPS-120 W and 622 patients with the use of XPS-180 W) at 7 international centers. All data were collected prospectively. Comparative analysis was performed between XPS and HPS according to PV measured by transrectal ultrasound. RESULTS: The XPS compared with HPS, allowed significantly reduced laser and operative time (29.6 minutes vs 65.8 minutes and 53 minutes vs 80 minutes, respectively; P <.01 for both). The number of fiber used during the procedures was significantly reduced with the XPS system (1.11 vs 2.28; P <.01), whereas total energy delivered was lower (250.2 kJ vs 267.7 kJ; P = .043). Overall, the mean operative time, mean laser time, and mean energy were all significantly increased according to PV >80 mL vs <80 mL. However, when stratified according to PV, XPS demonstrates significant advantages compared with HPS, regardless of prostate size in all operative parameters (P <.01). CONCLUSION: The new XPS-180 W system exhibits significant advantages in all surgical parameters compared with the HPS-120 W system. Overall, with XPS-180 W and HPS-120 W, mean operative time, laser time, and energy usage increased according to PV. This suggests that preoperative evaluation of PV by transrectal ultrasound should be mandatory.