AUA Guideline Committee Members Determine Quality of Artificial Intelligence‒Generated Responses for Female Stress Urinary Incontinence.

INTRODUCTION: Stress urinary incontinence (SUI) affects countless women worldwide. Given ChatGPT's rising ubiquity, patients may turn to the platform for SUI advice. Our objective was to evaluate the quality of clinical information about SUI from the ChatGPT platform. METHODS: The most-asked patient questions regarding SUI were derived from patient materials from societal websites and forums, and queried using ChatGPT 3.5. The responses from ChatGPT were compiled into a survey and disseminated to 3 AUA guideline committee members who developed the Surgical Management of Female SUI guidelines. They were asked to grade responses on reliability, understandability, quality, and actionability using DISCERN and Patient Education Materials Assessment Tool standardized questionnaires. Accuracy was assessed with a 4-point Likert scale and readability using Flesch Reading Ease score. RESULTS: The overall material was rated as moderate to moderately high quality (DISCERN = 3.73/5) with potentially important but no serious shortcomings. Reliability and quality were reported to be 63% and 75%. Understandability was 89%, actionability 18%, and accuracy 88%. All question domains were rated at moderate or better. Actionability was poor in all domains. Every response was "hard to read" translating to a college graduate reading level. CONCLUSIONS: The urologic community should critically evaluate this platform's output if patients are to use it for adjunctive medical guidance. AUA committee members, who are experts in the field, rate ChatGPT-produced responses on SUI as moderate to moderately high quality, moderate reliability, excellent understandability, and poor actionability utilizing standardized questionnaires. The reading level of the material was advanced, which is an area of potential improvement to make generated responses more comprehensible.

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.

White Matter Integrity in Men With Benign Prostatic Hyperplasia and Bladder Outlet Obstruction and Its Contribution to Lower Urinary Tract Symptoms.

PURPOSE: Lower urinary tract symptoms (LUTS) associated with bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) can negatively impact quality of life. We evaluated the structural connectivity of the brain in men with BPH with chronic BOO using diffusion tensor imaging (DTI). METHODS: Ambulatory male patients aged ≥45 years with BPH and BOO were recruited. LUTS was defined as an International Prostate Symptom Score (IPSS) ≥12 and a maximum urinary flow rate ≤15 mL/sec. Upon recruitment, uroflowmetry and validated questionnaires regarding bladder status were collected. DTI images from each subject were aligned with the ICBM-DTI-81 atlas, defining 50 white matter tracts (WMTs). The mean values of DTI parameters-fractional anisotropy and mean diffusivity-for each WMT were extracted. These measures were then utilized to compute Pearson correlation coefficients with clinical parameters. Objective clinical parameters included uroflowmetry parameters, postvoid residual (PVR) volume, and bladder capacity. Subjective clinical parameters were assessed using validated questionnaires: the IPSS, Incontinence Symptom Index, and Sexual Health Inventory for Men. RESULTS: The correlation analysis revealed 15 WMTs that showed statistically significant associations (P<0.05) with objective and subjective clinical parameters. Eight tracts were associated with uroflowmetry parameters: maximum flow rate (Qmax), mean flow rate (Qmean), and PVR. Among these tracts, the middle cerebellar peduncles and left medial lemniscus were associated with Qmax; the genu of the corpus callosum, left superior corona radiata, corticospinal tract, right medial lemniscus, posterior corona radiata with Qmean; and the left posterior corona radiata with PVR. Seven tracts also demonstrated significant associations with the IPSS. CONCLUSION: Our results suggest correlations between the preserved white matter integrity of specific WMTs and the severity of LUTS based on objective and subjective clinical parameters, leading us to believe that a distinct pathology of the central nervous system might exist.

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.

Higher neural contribution underlying persistent lower urinary tract symptoms in men with Benign Prostatic Hyperplasia undergoing bladder outlet procedures.

INTRODUCTION AND BACKGROUND: Benign Prostatic Hyperplasia (BPH) affects the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Surgical options for bladder outlet obstruction (BOO) are currently offered for symptomatic improvement. However, 30% of patients report persistent LUTS after BOO procedures. Neuroplasticity induced by BPH and BOO can be contributory in these men, having different brain activation patterns during the micturition cycle. Our multimodal functional Magnetic Resonance Imaging (fMRI) study will identify for the first time, structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and following BOO procedures. We hypothesize that men with symptomatic BPH with persistent LUTS following BOO procedures have a distinct brain activation pattern in regions of interest (ROIs) of the micturition cycle. METHODS: Male patients older than 45 years of age undergoing BOO procedures will be enrolled and categorized in two groups. Group 1: patients with BPH with significant improvement in storage symptoms after BOO procedures. Group 2: patients with BPH with persistent storage symptoms after BOO procedures. Our control group are male patients without LUTS undergoing radical prostatectomy. Patients will complete subjective questionnaires and post void residual at clinic visits. BOLD signals at full urge will be measured at baseline and following BOO procedures. All patients will undergo fMRI studies at baseline and at 6 months. Clinical data will be correlated to BOLD signal changes as well as to structural changes in white matter tracts. ETHICS AND DISSEMINATION: After IRB approval, patients will be recruited and properly consented before enrolling to this study. Results of neural contribution to lower urinary tract symptoms will be presented at national and international meetings and will be published in scholarly journals.

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.

Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezum system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: This report evaluates clinical experience with the Rezum system after US Food and Drug Administration clearance in consecutive cases accrued by multiple community urologists for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Treatment techniques for transurethral convective radiofrequency water-vapor thermal therapy and outcomes with up to 12 months' follow-up are presented. MATERIALS AND METHODS: A total of 131 patients with moderate-severe LUTS were included in a retrospective analysis of BPH procedures with the Rezum system. Pre- and postprocedure assessments included International Prostate Symptom Score (IPSS), quality of life, peak urinary flow rate, voided volume, and postvoid residual urine volume. Urologists used their own discretion for patient selection, with variable prostate sizes, LUTS severity, urinary retention, or presence of an obstructing median lobe. Safety signals and surgical retreatment rates were monitored prospectively. RESULTS: Men aged 47-96 years with prostates 13-183 cm3 showed significant improvement in IPSS, quality of life, and postvoid residual volume durable through 12 months after thermal therapy. Patients with either moderate (IPSS 8-19) or severe (IPSS 20-35) symptoms achieved significantly improved scores. Postprocedure adverse events normally anticipated and related to endoscopic instrumentation were transient and mild-moderate in nature. No de novo erectile or ejaculatory dysfunction was reported. CONCLUSION: This study corroborates prior published pilot and randomized controlled trial results indicating significant relief of urinary symptoms and reproducibility of responses to thermal therapy. Convective radiofrequency thermal therapy with the Rezum system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.

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.