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To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up.WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation.International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613).Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.

To assess the outcomes of a "less is more" treatment approach consisting of a single water vapor treatment per prostate lobe for benign prostatic hyperplasia (BPH).Retrospective cohort study in a single urologic clinic of men with moderate to severe symptomatic BPH with and without median lobes undergoing thermal water vapor therapy. Single injection of thermal water vapor was given in each prostate lobe. The primary endpoint compared maximum urine flow rate (Qmax), post-void residual (PVR), International Prostatism Symptom Score (IPSS), and the IPSS Quality of Life scale (IPSS QoL) at baseline and at 1, 3, 6, and 12 months.The study included 52 men with mean prostate volume and IPSS of 52.8cc and 20.3cc, respectively. IPSS was reduced by -3.95 ± 7.5 at 3 months (P = .02875), -8.5 ± 9.3 at 6 months (P = .01767), and -11.63 ± 8.4 at 12 months (P = .005908). IPSS QoL improved by -1.75 ± 1.2 t 12 months (P = .003799) and QMax by 5.36 ± 3.7 mL/s at 12 months (P = .008445). Time to post-operative catheter removal was 3.5 ± 1.3 days. One patient reported ejaculatory dysfunction. All other adverse events were mild to moderate in severity and resolved quickly.Thermal water vapor therapy with single injection per lobe is both an effective and safe treatment for BPH that provides comparable improvements in lower urinary tract symptoms and quality of life to the traditional approach that employed variable number of injections by prostate volume.

Objective To develop and perform a usability testing of a mobile application (app) with representative users of surgeons and female patients undergoing stress urinary incontinence (SUI) surgery. Methods A mobile app was developed with the Medical Device Epidemiology Network (MDEpiNet) High-Performance Integrated Virtual Environment (HIVE) to streamline the collection of patient-reported outcomes following SUI surgery using validated questionnaires. It was designed as a collaborative effort with the Women's Health Initiative (WHI), including patient and surgeon involvement. The app evaluation questions addressed the user's rating on the clarity and length of the questions and the comfort level in using the interface for patients to report post-operative outcomes and surgeons to review them. Results A total of twenty patients and 5 surgeons tested the mobile app and reported their experience and level of satisfaction. The average patient experience score was 9 out of ten, with ten being the best. Eleven patients (55%) were interested in replacing in-person follow-up visits with the app. The surgeons reported an average user experience score of 8.6 out of ten. Four surgeons (80%) were interested in replacing in-person visits with the app. The combined experience score between all users was 8.9 out of ten. Fifteen out of twenty-five users (60%) showed interest in replacing in-person visits with the app. Conclusion The mobile app for SUI captured important patient-reported outcomes with a high satisfaction reporting from patients and surgeons.

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=0.012) 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. Conclusions 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.

Objectives To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model. Methods The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology. Results The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two. Conclusion In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.

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.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.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.Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

To investigate recent trends in mesh use for pelvic organ prolapse (POP)-related reconstruction procedures.Using the 2001-2011 5% Medicare claims database, we identified POP diagnoses and related procedures. Transvaginal mesh use and sacrocolpopexy were first reported in 2005 and 2004, respectively.A total of 613,160 cases of vaginal and abdominal POP repair procedures were identified. The majority of procedures involved multiple compartments. The rate of mesh use increased dramatically from 2% of repairs in 2005 to 35% by 2008. After the Food and Drug Administration warning in 2008, mesh use plateaued and then decreased in 2011. Mesh was used more commonly in younger (odds ratio [OR] 0.722, P.001), white (OR 0.712-0.791 for other races, P.001) women in the South (OR 0.741-0.848 for non-South regions, P.001). Starting in 2008, the rate of sacrocolpopexy procedures almost doubled yearly until 2011. Sacrocolpopexy was more common in younger patients (49% in women70 years) and in white women (88%); the majority of sacrocolpopexies were performed in the South (60%) and laparoscopically (83%-98%).The treatment of POP has changed over time. The use of mesh increased significantly until 2008, after which it plateaued following the Food and Drug Administration warning regarding mesh-related complications. Concurrently, the number of sacrocolpopexy procedures increased significantly starting in 2008 as the use of laparoscopic and/or robotic technique and concern regarding transvaginal mesh increased.

Objective To examine the cost-effectiveness of endoscopic treatment of low-risk non–muscle-invasive bladder cancer (NMIBC) via office-based fulguration vs operating room–based transurethral resection of the bladder (TURB). Methods A Markov state-transition model was created to simulate and compare the economic burden of managing patients with office-based fulguration vs TURB. Direct procedural and hospitalization costs were queried from our institution. Patients were modeled as being followed up routinely with flexible cystoscopy, whereas tumor recurrences were treated with either fulguration or TURB. Results A strategy of office-based fulguration was more cost-effective than TURB ($1171 per quality-adjusted life year [QALY] vs $1208 per QALY) to treat recurrent NMIBC over a 5-year period. Fulguration was both more effective (14.94 vs 14.91 QALYs) as well as less expensive ($17,494 vs $18,005), thus dominating TURB. The incremental cost-effectiveness ratio was −$18,440 per QALY. Sensitivity analysis demonstrates that the relative costs of the procedures are more significant in determining cost-effectiveness than their respective utilities. Conclusion Office-based cystoscopy and fulguration was more cost-effective than TURB for treating recurrent low-risk NMIBC. Adherence to an office-based treatment plan can lead to significant cost savings with a decreased therapeutic burden over the lifetime of a patient with NMIBC.

Objective To investigate contemporary trends in the use of midurethral sling procedures for the surgical correction of female stress urinary incontinence over the past decade. Methods Annualized case log data for female incontinence surgeries from certifying and recertifying urologists were obtained from the American Board of Urology. Descriptive analysis of the number and type of cases per year was performed. Associations between surgeon characteristics and the use of female incontinence procedures were evaluated. Results A total of 6355 nonpediatric urologists applied for certification or recertification between 2003 and 2012. Two-thirds (4185) reported performing any procedures for female incontinence. Procedures sharply increased from 4632 in 2003 to 7548 in 2004, then remained relatively stable between 2005 and 2012 (range, 8014-10,238 cases). Traditional procedures decreased from 17% of female incontinence procedures in 2003 to 5% in 2004 to

Objective To report on a safe endoscopic management technique for the treatment of an anastomotic stricture (AS) in patients with an artificial urinary sphincter (AUS). Methods Five patients with a history of salvage prostatectomy after radiation therapy that developed an AS after AUS placement were treated with a rigid ureteroscope and a Holmium YAG (Ho: YAG) laser to incise the AS. The AUS was opened and deactivated but not decoupled or removed during the procedure. The rigid ureteroscope allowed complete control of the laser fiber to incise the stricture at the 3 and 9 o' clock positions and then circumferentially. Results There were no intraoperative complications and the mean operative time was 42.6 minutes. Of the 5 patients who underwent holmium laser incision of an AS after AUS placement, none developed AUS malfunction or required device replacement. No patients reported worsening of urinary incontinence after treatment. Two patients required repeat holmium laser incision for AS recurrence. Conclusion Using a rigid ureteroscope and a holmium laser to incise an AS after AUS placement seems to be a safe management option that does not damage the AUS or result in worsening incontinence. This treatment strategy provides an endoscopic alternative to using open surgical technique to uncouple or remove the AUS while treating the AS.

Objective To characterize the clinicopathologic features of patients who developed pubovesical fistula (PVF) after treatment of prostate cancer and to identify some possible methods of reducing the incidence of this rare complication for which no well-established guidelines exist. Methods We identified men at 2 centers who presented with PVF after prostate cancer treatment from January 2000 to December 2010. Prostate cancer was treated with radiotherapy (RT) or radical prostatectomy, or both. Patients with bladder neck contracture (BNC) received endoscopic treatment. The demographic and clinical data were collected. Results Of the 12 patients who presented with PVF, the treatment of prostate cancer was external beam RT in 8 (5 of whom underwent subsequent salvage radical prostatectomy) and radical prostatectomy (followed by salvage RT) in 4. All patients developed BNC requiring endoscopic treatment. The median interval between primary endoscopic treatment of BNC and the development of PVF was 35.9 months (range 0.6 to 97). The most common presenting symptom was suprapubic or groin pain. Of the 12 patients, 10 ultimately required cystectomy with urinary diversion. Conclusion The treatment of prostate cancer with RT followed by the development of BNC requiring endoscopic intervention appears to be associated with PVF development Despite conservative measures, patients who developed PVF often required cystectomy with urinary diversion. To avoid PVF, care should be taken during endoscopic intervention for BNC in patients who have received RT for prostate cancer. PVF should be on the differential diagnosis of patients with a history of RT and BNC who develop pubic pain or recurrent urinary tract infection.