Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer.

Importance: Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited. Objective: To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis. Design, Setting, and Participants: This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023. Exposure: At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months. Main Outcomes and Measures: Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters. Results: A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months. Conclusions and Relevance: In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.

An Innovative Technique for Ejaculation-Sparing Prostatic Enucleation with Thulium:YAG Laser.

Purpose: We report our experience with 100 patients who underwent an innovative prostate enucleation technique that spares the complete urethral-plate from the veru montanum to the bladder neck using a low-energy thulium laser emission. The aim of our study was to evaluate the short-term effects of this procedure on ejaculation preservation and urinary obstruction. Materials and Methods: The International Prostate Symptom Index (IPSS), quality of life (QoL), and Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EJD) Short Form were used as validated instruments to quantify ejaculatory dysfunction before and 6 months after the surgery. Results: The median IPSS score pre- and postoperatively was 20 and 5, respectively (p < 0.0001); QoL dropped from a median of 4-1 (p < 0.0001); and the mean preoperative maximal flow rate improved significantly (8.5 vs 21.2 mL/min) (p < 0.0001). Furthermore, there was significant reduction in postvoid residual postoperatively (p < 0.0001). Postoperative ejaculatory function was preserved in 92/100 patients (92%). According to the MSHQ-EJD score, patients reported a slight nonsignificant decrease in frequency of ejaculation (item 1), force of expulsion (item 2) and reduction in semen volume during ejaculation (item 3), with the exception of ejaculation discomfort (item 4). Conclusion: According to our results, complete removal of the apical tissue, which has been advocated as an integral part of the so called ejaculatory hood, does not interfere with ejaculation if the ventral lissosphincter remains intact.

Female paraurethral leiomyoma: treatment and long-term follow-up.

INTRODUCTION: We describe our experience with evaluating the ideal management of female paraurethral leiomyomas from imaging to surgery and follow-up. METHODS: Between January 2009 and January 2012, we treated six women (age range 32-49 years) affected by paraurethral leiomyoma of different sizes. RESULTS: All the six patients underwent transvaginal excision of the mass. They are free of recurrence at follow-up (range 32-72 months). Two patients developed stress urinary incontinence after the excision: in both cases, incontinence was corrected by a tension-free vaginal tape-obturator (TVT-O) placement. In one patient, a fascial sling was necessary to repair a urethral lesion that developed during surgical excision of the mass. CONCLUSION: A well-defined protocol for diagnosing and managing a paraurethral mass had not been established as yet due the rarity of the mass. We suggest performing pelvic magnetic resonance imaging (MRI) as a primary examination, followed by lesion biopsy. Complete surgical resection performed transvaginally should be the treatment of choice. As paraurethral leiomyomas does not originate from intraurethral smooth-muscle component, urethral lesion is rare. Excision of female urethral leiomyoma transvaginally is safe, and postoperative urinary incontinence, if any, can be easily corrected with minimally invasive tecniques.

Thulium Laser Endoscopic En Bloc Enucleation of Nonmuscle-Invasive Bladder Cancer.

OBJECTIVES: To evaluate if thulium laser enucleation of bladder tumor (ThuLEBT) offers any advantage over monopolar resection of nonmuscle-invasive bladder cancer (NMIBC) without increasing complications. PATIENTS AND METHODS: From February 2012 to September 2013, 58 patients (41 males and 17 females) newly diagnosed with having a single papillary bladder tumor more than 1 cm in diameter were selected for this prospective study on ThuLEBT. A similar historical cohort of 61 patients who underwent traditional monopolar resection (TURB-T) of NMIBC (Group B) was used to compare the two procedures. RESULTS: Mean tumor diameter in the ThuLEBT group was 2.5 cm (range 0.5-4.5). Mean operative time was 25 minutes (range 12-30). Re-resection and cold cup biopsy of the tumor base (in 90 days) were negative for bladder cancer (BC) persistence or recurrence in all patients with NMIBC treated with ThuLEBT. In Group B, seven patients were found with disease persistence. In eight cases of TURB-T patients, no detrusor muscle was identified, while it was always easily identified in the ThuLEBT group. No patient in Group A experienced obturator nerve reflection intraoperatively and no bladder perforation was evidenced in dome-located neoplasm; when involved, ureteral meatus was sharply excised without subsequent postoperative evidence of distortion. No significant intraoperative or postoperative bleeding occurred in all but one patient in the two groups. CONCLUSIONS: ThuLEBT may represent a potential alternative to TURB-T, which nowadays is considered the standard for diagnosis and treatment of NMBIC. In our study, ThuLEBT allowed accurate reporting of neoplastic depth invasion, suggesting the possibility to avoid a second-look resection at 90 days. All the different intravesical sites of the BC may be enucleated with the thulium laser, which offers advantages over the monopolar energy, especially when the tumor is located in the lateral bladder wall, at the bladder dome, or in the perimeatal zone.

Laparoscopic microwave ablation and enucleation of small renal masses: preliminary experience.

Advancements in imaging and laparoscopy have led to the expansion of minimally invasive techniques in the ablation of small renal masses (SRMs). We report the results of a study aimed at assessing the efficacy of thermoablative microwave (MW) effects on SRMs and the haemostatic as well as necrotic MW effects on the parenchyma surrounding the neoplasm. From November 2008 to October 2010, 10 patients with SRMs underwent laparoscopy-guided Tru-Cut biopsy, MW tumour ablation, and enucleation. Mean age was 66 yr (range: 46-84 yr). Mean renal tumour diameter was 2.75 cm (range: 1.3-4.2 cm). MW antennas were applied one to three times depending on tumour volume, location, and shape. After MW thermoablation, laparoscopic enucleation was performed to evaluate the histopathologic and haemostatic effects of MW. The mean MW antenna application time was 14.1 min (range: 4-30 min). Enucleation did not require renal pedicle clamping in any of the cases because no significant bleeding took place. Preablation pathology revealed clear cell renal carcinoma of Fuhrman grade I-II in all cases. Postablation pathology showed extensive coagulative necrosis without skipped tumour areas. No intra- or postoperative complications were reported. Histopathologic effects on SRMs provide consistent proof of principle for future studies.

Recurrent pseudodiverticula of female urethra: five-year experience.

OBJECTIVES: To report our experience of transvaginal diverticulectomy with pubovaginal sling placement in a series of 32 women with recurrent urethral pseudodiverticula. METHODS: A total of 32 women underwent surgical repair from January 2000 to June 2007. Of the 32 women, 12 had undergone other concomitant previous urethral surgery, predominantly for stress urinary incontinence. Transvaginal excision of the diverticulum and concomitant pubovaginal sling placement were performed routinely. The women were evaluated postoperatively for symptom relief, anatomic result, and postoperative continence status at 1, 6, and 12 months and annually thereafter. Pelvic magnetic resonance imaging was repeated after 1 year. RESULTS: The mean follow-up was 4.3 years. In all cases, the voiding urethrogram after catheter removal showed a good urethral shape with an absence of urinary leaks. At the postoperative urodynamic investigation, 27 patients had an unobstructed and 5 an equivocal Blaivas-Groutz nomogram. Three patients (20%) reported a persistent degree of stress urinary incontinence, including 2 with grade 1 stress urinary incontinence and 1 with mixed incontinence. Two patients presented with clinically evident diverticulum recurrence, and in 1 patient, an intraurethral diverticulum, was found at the 1-year magnetic resonance imaging examination. CONCLUSIONS: A pubovaginal sling added routinely to all diverticulectomy procedures offers significant support to the urethral repair and/or prevention of urinary incontinence, including in recurrent cases, and does not increase the risk of erosion into the urethra or fistula formation.

Male bulbourethral sling after radical prostatectomy: intermediate outcomes at 2 to 4-year followup.

PURPOSE: We reviewed our experience with 49 consecutive patients undergoing a male sling procedure. MATERIALS AND METHODS: The 7-item International Prostate Symptom Score and 22-item incontinence quality of life questionnaire (although not validated in Italian) were used to assess the clinical impact of the bulbourethral sling. Surgical outcome was also assessed by videourodynamics at 1 year. Urodynamic success was defined as no leakage during videourodynamic evaluation. RESULTS: Mean followup was 32 months (range 26 to 48). Preoperatively 3 patients used 2 pads daily (mild incontinence), 34 used 3 to 5 (moderate incontinence) and the remaining 12 used more than 5 (severe incontinence). Clinical success was defined as a decrease in pad use to completely dry (no pad) or to social continence (1 pad daily) at followup. Of the 49 patients 38 (77%), 33 (67%) and 63% (31) were considered socially continent at the 3-month, 1-year and 3-year followup, respectively. Only 15 of the 49 patients (30%) were considered completely dry at the 3-year followup. Significant perineal pain was reported in the early postoperative period but it resolved in all patients. Infection occurred in 3 patients, while no erosion was found. CONCLUSIONS: The male perineal sling is a safe surgical option for post-prostatectomy urinary incontinence, especially when strict patient selection is done. Patient satisfaction is superior to urodynamic results and the procedure allows physiological voiding. Patients should be informed of the possibility of progressive failure with time and significant perineal pain in the early postoperative period.

Dorsal buccal mucosa graft urethroplasty for female urethral strictures.

PURPOSE: We describe the feasibility and complications of dorsal buccal mucosa graft urethroplasty in female patients with urethral stenosis. MATERIALS AND METHODS: From April 2005 to July 2005, 3 women 45 to 65 years old (average age 53.7) with urethral stricture disease underwent urethral reconstruction using a dorsal buccal mucosa graft. Stricture etiology was unknown in 1 patient, ischemic in 1 and iatrogenic in 1. Buccal mucosa graft length was 5 to 6 cm and width was 2 to 3 cm. The urethra was freed dorsally until the bladder neck and then opened on the roof. The buccal mucosa patch was sutured to the margins of the opened urethra and the new roof of the augmented urethra was quilted to the clitoris corpora. RESULTS: In all cases voiding urethrogram after catheter removal showed a good urethral shape with absent urinary leakage. No urinary incontinence was evident postoperatively. On urodynamic investigation all patients showed an unobstructed Blaivas-Groutz nomogram. Two patients complained about irritative voiding symptoms at catheter removal, which subsided completely and spontaneously after a week. CONCLUSIONS: The dorsal approach with buccal mucosa graft allowed us to reconstruct an adequate urethra in females, decreasing the risks of incontinence and fistula.

Effects of a shared protocol between urologists and general practitioners on referral patterns and initial diagnostic management of men with lower urinary tract symptoms in Italy: the Prostate Destination study.

OBJECTIVE: To assess whether adopting a shared protocol between urologists and general practitioners (GPs) might change diagnostic procedures and referral patterns in the management of men with lower urinary tract symptoms (LUTS). SUBJECTS AND METHODS: Forty-five urological centres and 263 GPs in Italy participated in this prospective study. Procedures adopted by GPs for evaluating five consecutive patients (aged > or = 50 years) were compared before (phase 1) and after (phase 2) implementation of the shared protocol. An evidence-based diagnostic algorithm was developed and approved by participating urologists and presented to local GPs at a training session. Protocol modifications were allowed after discussion with GPs. Direct costs of diagnostic procedures carried out before and after implementing the protocol were calculated from the perspective of the national health service. RESULTS: In all, 903 patients were evaluable in phase 1 and 856 in phase 2. Implementation of the protocol did not change referral patterns, with about half the patients being managed entirely by GPs. The use of a digital rectal examination by GPs increased from 32% to 41%, use of transrectal and suprapubic ultrasonography decreased from 33% to 23% and 53% to 44%, respectively, (all P < 0.001) and use of the International Prostate Symptom Score increased from 4.5% to 23.1% (P < 0.001). Overall, protocol-recommended tests were used more frequently, while those not recommended decreased after implementing the protocol. However, overuse of the tests not recommended (i.e. urine culture and free/total prostate specific antigen ratio) remained high. The mean cost per patient of diagnostic procedures ordered by GPs decreased from Euros 71.82 to Euros 61.93, with Euros 9.9 saved for each patient. CONCLUSION: Our intervention failed to decrease the percentage of cases of LUTS being referred to specialists, but was moderately effective in inducing changes in the diagnostic management by GPs that were indicative of increased compliance with best-practice principles, and produced cost savings of 13.8%.

Diagnostic procedures by Italian general practitioners in response to lower urinary tract symptoms in male patients: a prospective study.

BACKGROUND: The aim of this prospective, multicentre, observational study was to evaluate the initial diagnostic procedures for lower urinary tract symptoms (LUTS) carried out by Italian general practitioners (GPs). METHODS: Data were collected from 445 GPs in Italy regarding the initial clinical decisions and diagnostic procedures adopted for the management of 1399 male patients with LUTS aged >or= 50 years. RESULTS: 50.3% of patients were managed by the GP,4.9% were referred to the urologist immediately and 44.8% after carrying out some diagnostic procedures. A digital rectal examination was performed in only one-third of the patients, many of whom were not subsequently referred to the urologist (26.4%). Laboratory tests that are usually recommended (i.e. PSA, urinalysis and serum creatinine) were undertaken in 98.3% of patients, while tests that are generally considered optional (such as flowmetry) were undertaken in up to 64%. Other generally not recommended investigations, such as ultrasonography, were carried out in 77.2%. The mean time to diagnosis was significantly shorter when the urologist was not involved (36.0 days for GP only management vs 51.4 days for immediate referral and vs 43.4 days for delayed referral (p = 0.0003). CONCLUSIONS: Our findings show a propensity for the majority of Italian GPs to deal with LUTS patients in a primary setting without immediate referral to the urologist. In principle, this trend could be beneficial for the patient (i.e. by reducing time to diagnosis) and cost saving for the national health system. However, the diagnostic procedures selected by the GPs were not in line with best evidence practice recommendations. Shared-care protocols involving both GPs and urologists may contribute to better implementation of the guidelines on the management of LUTS and benign prostatic hyperplasia in Italy.