Radical cystectomy or trimodality therapy for muscle-invasive bladder cancer: a qualitative study exploring patient priorities and counselling needs when making a treatment choice.

BACKGROUND: This study aims to explore the priorities and counselling needs of patients with muscle-invasive bladder cancer faced with a decision between radical cystectomy and trimodality therapy. METHODS: We performed a qualitative study according to the phenomenological approach. Sixteen muscle-invasive bladder cancer survivors who underwent radical cystectomy or trimodality therapy completed a semi-structured interview between May 2022 and February 2023. Patients were recruited via Ghent University Hospital and a patient organisation. Data were analysed with inductive thematic analysis by a multi-disciplinary team using an iterative approach and investigators' triangulation. RESULTS: Four main priorities determining the treatment decision were identified. (1) curing the disease; (2) health-related quality of life (physical, mental and social); (3) confidence in the treatment, which was mainly based on trust in the clinician; and (4) personal attributes. Trust in the clinician can be achieved by fulfilling the patient's information needs (accurate, complete, clear, impartial, personalised, realistic, and transparent information), ensuring accessibility of the clinician, and creating a clear and personalised treatment plan, involving patients to the extend they desire. Many patients considered a patient decision aid as a valuable asset in this process. CONCLUSION: Priorities vary between patients with muscle-invasive bladder cancer. Identifying individual priorities and offering personalised information about them is crucial for ensuring trust in the clinician and confidence in the treatment. Use of a patient decision aid can be beneficial in this process.

Variant genital gender-affirming surgery: a systematic review.

OBJECTIVE: To review the available literature on variant genital gender-affirming surgery (GGAS), including the reasons for performing it, the surgeries themselves and their outcomes. METHODS: A systematic review on the performance of variant GGAS was conducted (International Prospective Register of Systematic Reviews [PROSPERO] identifier: CRD42022306684) researching PubMed, Embase, Web of Science and Cochrane databases from inception up to 31 December 2023. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed, and risk of bias was assessed for each study using the five-criteria quality assessment checklist. RESULTS: In total 23 case series were included, of which 17 on masculinising and six on feminising surgeries. Patients mainly choose these surgical procedures out of personal desire to avoid risk of complication or because they do not have dysphoria about certain parts of their genitalia. Complications in masculinising surgeries primarily arose from the extended urethra, which could be mitigated through primary perineal urethrostomy. Both phalloplasty and metoidioplasty carried a higher risk of urethral complications when the vagina was preserved. In feminising surgeries, risk of visceral damage and requirement for lifelong self-dilation could be avoided when vulvoplasty was performed without vaginal canal creation. All studies had a high risk of bias. CONCLUSION: This review highlights the importance of variant GGAS and acknowledges the preferences of transgender and gender-diverse individuals. Patients should be informed about the risks and benefits of each step in these procedures.

Management of the Devastated Bladder Outlet after Prostate CANCER Treatment.

PURPOSE OF REVIEW: Devastating complications of the bladder outlet resulting from prostate cancer treatments are relatively uncommon. However, the combination of the high incidence of prostate cancer and patient longevity after treatment have raised awareness of adverse outcomes deteriorating patients' quality of life. This narrative review discusses the diagnostic work-up and management options for bladder outlet obstruction resulting from prostate cancer treatments, including those that require urinary diversion. RECENT FINDINGS: The devastated bladder outlet can be a consequence of the treatment of benign conditions, but more frequently from complications of pelvic cancer treatments. Regardless of etiology, the initial treatment ladder involves endoluminal options such as dilation and direct vision internal urethrotomy, with or without intralesional injection of anti-fibrotic agents. If these conservative strategies fail, surgical reconstruction should be considered. Although surgical reconstruction provides the best prospect of durable success, reconstructive procedures are also associated with serious complications. In the worst circumstances, such as prior radiotherapy, failed reconstruction, devastated bladder outlet with end-stage bladders, or patient's severe comorbidities, reconstruction may neither be realistic nor justified. Urinary diversion with or without cystectomy may be the best option for these patients. Thorough patient counseling before treatment selection is of utmost importance. Outcomes and repercussions on quality of life vary extensively with management options. Meticulous preoperative diagnostic evaluation is paramount in selecting the right treatment strategy for each individual patient. The risk of bladder outlet obstruction, and its severest form, devastated bladder outlet, after treatment of prostate cancer is not negligible, especially following radiation. Management includes endoluminal treatment, open or robot-assisted laparoscopic reconstruction, and urinary diversion in the worst circumstances, with varying success rates.

Vulvar pagetoid urothelial intraepithelial neoplasia: a case report.

BACKGROUND: Pagetoid urothelial intraepithelial neoplasia (PUIN) is a form of secondary Extramammary Paget Disease (EMPD). It is a rare malignant condition seen on the female genitalia synchronous or metachronous with bladder cancer (BC). CASE PRESENTATION: A 66-year-old female presented with PUIN at the labia minora 2 years after an open anterior pelvic exenteration with ileal conduit urinary diversion for carcinoma in situ (CIS) of the bladder. PUIN of the vulva and vagina was confirmed by a punch biopsy and the patient underwent a radical vaginectomy with urethrectomy and inguinal sentinel node procedure. Immunohistochemically EMPD was identified by the expression tumor protein 63 (p63), cytokeratin 7, and cytokeratin 20 (CK20). CONCLUSIONS: PUIN is a rare but distinct clinical entity as a form of secondary EMPD which can be differentiated from primary EMPD based on medical history, histology, and immunohistochemistry.

Multicentre, prospective study on local treatment of metastatic prostate cancer (LoMP study).

OBJECTIVES: To investigate the role of cytoreductive radical prostatectomy in addition to standard of care for patients with newly diagnosed metastatic prostate cancer. MATERIALS AND METHODS: This multicentre, prospective study included asymptomatic patients from 2014 to 2018 (NCT02138721). Cytoreductive radical prostatectomy was offered to all fit patients with resectable tumours, resulting in 40 patients. Standard of care was administered to 40 patients who were ineligible or unwilling to undergo surgery. The primary endpoint was castration resistant cancer-free survival at the time point of ≥50% events. The secondary endpoint was local event-free survival. Kaplan-Meier and Cox regression analyses with propensity-score analysis were applied. RESULTS: After a median (quartiles) follow-up of 35 (24-47) months, 42 patients became castration-resistant or died. The median castration resistant cancer-free survival was 53 (95% confidence interval [CI] 14-92) vs 21 (95% CI 15-27) months for cytoreductive radical prostatectomy compared to standard of care (P = 0.017). The 3-year estimates for local event-free survival were 83% (95% CI 71-95) vs 59% (95% CI 51-67) for cytoreductive radical prostatectomy compared to standard of care (P = 0.012). However, treatment group showed no significance in the multivariable models for castration resistant cancer-free survival (P = 0.5) or local event-free survival (P = 0.3), adjusted for propensity-score analysis. Complications were similar to the non-metastatic setting. Patients undergoing surgery were younger, with lower baseline prostate-specific antigen levels, alkaline phosphatase levels and metastatic burden. CONCLUSION: The present LoMP study was unable to show a difference between the two inclusion groups regarding castration resistant cancer-free survival for asymptomatic patients with newly diagnosed metastatic prostate cancer. These results validate previous evidence that, in well-selected and informed patients, cytoreductive radical prostatectomy is feasible and safe, with corresponding continence rates compared to the non-metastatic, high-risk setting. Whether cytoreductive radical prostatectomy could be a valuable option to achieve good local palliation needs to be further researched. Overall, the role of cytoreductive radical prostatectomy needs to be further explored in randomized studies to correct for potential bias.

Surgical Outcomes After Treatment of Urethral Complications Following Metoidioplasty in Transgender Men.

BACKGROUND: Several treatment options for urethral complications following metoidioplasty in transmen are described in the literature, yet little is known with regard to the surgical outcomes. AIM: The aim of this study was to analyze the surgical outcomes after treatment of urethral strictures and urethral fistulas following metoidioplasty. METHODS: A multicenter retrospective cohort study was conducted with transmen treated for strictures and fistulas after metoidioplasty in 3 tertiary referral centers. OUTCOMES: The primary outcome was the recurrence-free rate after surgical treatment of urethral strictures and urethral fistulas over a time period of 3 years postoperatively. RESULTS: Of 96 transmen included in this study with a urethral complication, 44 (46%) experienced a urethral fistula, 31 (32%) a urethral stricture, and 21 (22%) both complications simultaneously. The recurrence-free rate for urethral strictures following endoscopic management (ie, urethral dilation or direct visual internal urethrotomy) was 61% after 1, 50% after 2, and 43% after 3 years, compared to 82% following open treatment options after 1, 2, and 3 years (P = .002). Open treatment options were Heineke-Mikulicz procedure (7/9, 78% success), excision and primary anastomosis (3/3, 100%), 2-stage without graft (9/9, 100%), pedicled flap urethroplasty (1/1, 100%), and buccal mucosa graft urethroplasty (2/4 [50%] single-stage, 1/1 [100%] 2-stage). The recurrence-free rate for small urethral fistulas located at the pendulous urethra was 79% after 1, and 72% after 2 and 3 years, compared to 45% after 1, and 41% after 2 and 3 years for large fistulas, generally located at the urethral anastomoses of the fixed urethra. Treatment options for urethral fistulas were fistulectomy (26/48, 54%), fistulectomy & (redo) colpectomy (7/11, 64%), buccal mucosa graft urethroplasty (1/1, 100%), and retubularization of the urethral plate (3/4, 75%). A colpectomy before or during reoperation of a urethral fistula at the proximal urethral anastomosis showed higher success rates compared to without a colpectomy (7/11 [64%] vs 2/13 [15%] respectively, P = .03). CLINICAL IMPLICATIONS: This study provides insight in the treatment possibilities and corresponding outcomes of urethral complications following metoidioplasty in transmen. STRENGTHS & LIMITATIONS: Strengths were the relatively large sample size and the overview of multiple treatment options available. Limitations were the heterogeneity of the cohort, underexposure of some surgical modalities, and absence of patient-reported outcomes. CONCLUSION: Open surgical techniques show better long-term outcomes in the management of urethral strictures compared to endoscopic options, and a colpectomy is beneficial before or during urethral fistula repair at the proximal urethral anastomosis. de Rooij FPW, Falcone M, Waterschoot M, et al. Surgical Outcomes After Treatment of Urethral Complications Following Metoidioplasty in Transgender Men. J Sex Med 2022;19:377-384.

POIROT trial: post-operative imaging after urethroplasty with peri-catheter retrograde urethrography or trial of voiding with voiding cysto-urethrography.

PURPOSE: This study directly compares peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG) as early postoperative imaging after urethroplasty and aims to assess whether pcRUG is superior at avoiding catheter reinsertion. METHODS: This is a single-center, prospective, interventional study comparing pcRUG and VCUG after urethroplasty in a within-patient fashion. All participants were first evaluated with pcRUG and subsequently with VCUG, unless pcRUG revealed significant contrast extravasation warranting further catheter stay. The primary end-point was to assess whether pcRUG is superior at avoiding catheter reinsertion compared with VCUG. Secondary end-points included the amount of significant contrast extravasations missed on pcRUG and the differences in radiation exposure. RESULTS: 80 patients were included in this study. Median (IQR) interval between surgery and first postoperative imaging was 16 (9-16) days. In 14/80 (18%) patients, the pcRUG showed significant contrast extravasation and catheter reinsertion was avoided, while this percentage is 0 by default for VCUG (p < 0.001). In the other 66/80 (82%) patients, a VCUG was performed and 1/66 (1.5%) of these was considered as significant contrast extravasation. Notably, 9/66 (14%) of these patients could not void during the investigation. Median (IQR) dose of radiation exposure during pcRUG and VCUG was, respectively, 120 (84-161) mGy/cm2 and 241 (169-334) mGy/cm2 (p < 0.001). CONCLUSIONS: After urethroplasty, pcRUG is a valuable alternative for VCUG as early postoperative imaging. It has a comparable diagnostic yield, averts the risk of having to reinsert the catheter, avoids the problem of patients being unable to void during the examination and requires significantly less radiation.

What is the role of single-stage oral mucosa graft urethroplasty in the surgical management of lichen sclerosus-related stricture disease in men? A systematic review.

PURPOSE: The benefits and harms of the available types of surgical management for lichen sclerosus-related (LS) strictures remain unclear and, thus, clear and robust clinical practice recommendations cannot be given. MATERIALS AND METHODS: To assess the role of single-stage OMGU in the management of LS strictures and explore how its benefits and harms compare with the alternative management options. Medline, Embase and Cochrane controlled trial databases (CENTRAL, CDSR) were systematically searched. Randomized (RCTs) and nonrandomized studies (NRCSs) comparing single-stage OMGU with other surgical management options for LS strictures and single-arm studies on single-stage OMGU were included. Risk of bias (RoB) was assessed. RESULTS: Of the 1912 abstracts identified, 15 studies (1 NRCS and 14 single-arm studies) were included, recruiting in total 649 patients. All studies were at high RoB. In the only NRCS available, stricture-free rate (SFR) for single-stage and staged OMGU was 88% vs 60%, respectively (p = 0.05), at a mean follow-up of 66.5 months. SFR range for single-stage OMGU in single-arm studies was 65-100% (mean/median follow-up, 12-59 months). Single-stage OMGU had low complication rates and beneficial impact on LUTS and QoL. CONCLUSIONS: The present SR highlights the methodological limitations of the available literature. In the absence of adverse local tissue conditions, and taking into consideration benefit-harm balance and surgeon's skills and expertise, single-stage OMGU can be justified in patients with LS strictures.

Urethral Complications After Metoidioplasty for Genital Gender Affirming Surgery.

BACKGROUND: Possible options of genital gender affirming surgery in transmasculine are metoidioplasty or phalloplasty. As opposed to phalloplasty, no flapbased neophallic reconstruction is needed in metoidioplasty. Urethral lengthening is needed in metoidioplasty if the patient desires voiding at the tip of the neophallus. This urethral lengthening poses the patient at risk for urethral complications. AIM: Our primary goal was to describe the morbidity and specific the urethral complications related to metoidioplasty. Second, we sought for predictors of these urethral complications. METHODS: Our institutional database was retrospectively analyzed to identify transmasculine who underwent metoidioplasty between 2006 and 2020. This cohort was further evaluated for surgical morbidity, urethral complications and potential predictors for urethral complications. OUTCOMES: The rate of surgical morbidity and urethral complications (temporary/permanent fistula, stricture or fistula and stricture) was calculated. Potential predictors evaluated herein were BMI, concomitant vaginectomy, active smoking and additional urethral lengthening (AUL). They were tested with logistic regression analysis with calculation of Odds Ratio (OR). RESULTS: Seventy-four patients underwent metoidioplasty with a median follow-up of 44 months. Median age was 26 years. AUL was done in 36 (48.6%) patients and established by a transverse preputial skin island and labium minus flap in respectively 34 and 2 patients. Within 30 days after metoidioplasty, 3 (4.1%) high-grade complications were noted. Urethral complications of any kind were noted in 42 (56.8%) patients. All fistulas, permanent fistulas and strictures were seen in resp. 34 (45.9%), 27 (36.5%) and 14 (18.9%) patients. AUL is a significant predictor for all urethral complications (OR 15.5), strictures (OR 24.5), all fistula's (OR 6.07) and permanent fistulas (OR 3.83). In contrast, smoking is only a predictor for all fistulas (OR 6.54) and permanent fistulas (OR 3.76). CLINICAL IMPLICATIONS: Obtaining information about the risk of complications is important in preoperative patient counselling. Patient who desires AUL are at higher risk to develop urethral complications and patients who continue to smoke at the period of metoidioplasty have a higher risk of fistula formation. STRENGTH & LIMITATIONS: Sufficient events to calculate predictors for urethral complications. However, this is a retrospective study with still a small number of patients with a relative short follow-up. CONCLUSION: Urethral complications are frequent after metoidioplasty and approximately 50% needs corrective surgery. AUL is an independent risk factor for fistula and stricture formation, whereas smoking is a risk factor for fistula formation. Waterschoot M, Hoebeke P, Verla W, et al. Urethral Complications After Metoidioplasty for Genital Gender Affirming Surgery. J Sex Med 2021;18:1271-1279.

Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes.

BACKGROUND: Until recently, all available erectile devices were manufactured in accordance with the anatomy of a native penis and led to high explantation rates when implanted in the neophallus. AIM: The aim of this study was to investigate surgical outcomes after implantation of the ZSI 475 FTM in the neophallus; this is the first erectile device specifically manufactured for implantation after phalloplasty. METHODS: This is a prospective observational study of patients undergoing implantation of the ZSI 475 FTM in the neophallus at a tertiary referral center since September 2017. Patients with a follow-up < 3 months were excluded from this analysis. OUTCOMES: Intraoperative and postoperative complications were analyzed with descriptive statistics and explantation-free survival was assessed using a Kaplan-Meier survival analysis. RESULTS: In total, 57 patients were included with a median (IQR) follow-up of 16 (10-21) months. No intraoperative complications occurred. Postoperative complications were seen in 18 of 57 (32%) patients and included cylinder protrusion (1/57, 1.8%), infection (8/57, 14%), malpositioning (4/57, 7.0%), mechanical failure (4/57, 7.0%), and urinary retention (1/57, 1.8%). A total of 13 of 57 (23%) devices were explanted which corresponds with an estimated explantation-free survival rate (SD) of 84% (4.9), 80% (5.6), and 80% (5.6) after, respectively, 6, 12, and 18 months of follow-up. CLINICAL IMPLICATIONS: By better addressing the specific needs after phalloplasty, this innovative erectile device might lead to improved cylinder protrusion, malpositioning, and mechanical failure rates, but device infection remains common. STRENGTHS & LIMITATIONS: This is the largest study on this topic to date and the first to report prospective data. Main limitations involve the relatively small sample size and the limited follow-up. CONCLUSION: Short-term cylinder protrusion, malpositioning, and mechanical failure rates are encouraging, although device infection remains a common problem. These complications resulted in a device explantation rate of 23%. Verla W, Goedertier W, Lumen N, et al. Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes. J Sex Med 2021;18:615-622.

Exercise prescription dose for castrate-resistant prostate cancer patients: a phase I prescription dose escalation trial.

PURPOSE: To determine the start exercise prescription dose in metastatic castrate-resistant prostate cancer (mCRPC) patients receiving second-line hormone treatment and recommended phase II exercise prescription. METHODS: Patients were enrolled in a 3 + 3 dose escalation phase I trial of aerobic, resistance, and flexibility exercises to evaluate dose-limiting tolerance and safety. Tolerance was defined as Borg score ≤ 16 and safety (pain) as a visual analogue scale score (VAS) ≤ 3 and CTCAE grade < 2. Dose level 1 (escalation start dose) was set at 15 min. Aerobic training (50-80% HRmax warm-up and cooling-down; and 65-80% HRmax. core), 1 set with 8-10 repetitions (reps.) resistance training (50-60% 1-RM, 8 exercises), and 1 set (30s) with 2 reps flexibility training (5 exercises). The prescription dose escalation was designed in four levels (from dose -1 to 3), with a dose escalation in volume and intensity of the exercises. RESULTS: Nine patients were included in two dosing cohorts and were under active treatment (n = 4 abiraterone acetate and n = 5 enzalutamide). Dose limiting safety concerns were observed in 2 out of 3 patients in dose level 2 and 1 patient out of 6 in dose level 1 due to VAS > 3 during resistance training and/or flexibility training. No tolerance issues were observed in the two dosing cohorts. The optimal start exercise prescription dose was set at dose level 1 due to safety issues at dose level 2. CONCLUSION: Our findings suggest that exercise is perceived tolerable in mCRPC patients receiving second-line hormone therapy. Caution is indicated on safety during performance of the exercises.

A multi-institutional critical assessment of dorsal onlay urethroplasty for post-radiation urethral stenosis.

PURPOSE: To critically evaluate a multi-institutional patient cohort undergoing Dorsal-Onlay Buccal Mucosal Graft Urethroplasty (D-BMGU) for recurrent post-radiation posterior urethral stenosis. METHODS: Retrospective multi-institutional review of patients with posterior urethral stenosis from 10 institutions between 2010-2019 was performed. Patients with at least 1-year follow-up were assessed. Patient demographics, stenosis characteristics, peri-operative outcomes, and post-operative clinical and patient-reported outcomes were analyzed. The primary outcomes were stenosis recurrence and de-novo stress urinary incontinence (SUI). Secondary outcomes were changes in voiding, sexual function, and patient-reported satisfaction. RESULTS: Seventy-nine men with post-radiation urethral stenosis treated with D-BMGU met inclusion criteria. Median age and stenosis length were 72 years, (IQR 66-75), and 3.0 cm (IQR 2.5-4 cm), respectively. Radiation modalities included: 36 (45.6%) external beam radiotherapy (EBRT), 13 (16.5%) brachytherapy (BT), 10 (12.7%) combination EBRT/BT, and 20 (25.3%) EBRT/radical prostatectomy. At a median follow-up of 21 months (IQR 13-40), 14 patients (17.7%) had stenosis recurrence. Among 37 preoperatively-continent patients, 3 men (8.1%) developed de-novo SUI following dorsal onlay urethroplasty. Of 29 patients with preoperative SUI all but one remained incontinent post-operatively (96.6%). Following repair, patients experienced significant improvement in PVR (92.5 to 26 cc, p = 0.001) and Uroflow (4.6 to 15.9 cc/s, p = 0.001), and high overall satisfaction, with 91.9% reporting a GRA of + 2 or better). CONCLUSION: Dorsal onlay buccal mucosa graft urethroplasty is a safe and feasible technique in patients with post-radiation posterior urethral stenosis. This non-transecting approach may confer low rates of de-novo SUI. Further research is needed to compare this technique with excisional urethroplasty.

Update on the management of complex strictures of the bulbar urethra.

PURPOSE OF REVIEW: This narrative review summarizes the most relevant literature published in 2019-2020 regarding urethroplasty for bulbar strictures. RECENT FINDINGS: We identified relevant papers focussing on new insights in the field of excision and primary anastomosis, graft augmentation urethroplasty and perineostomy for bulbar strictures and bulbomembranous strictures after radiotherapy or surgery for benign prostatic hyperplasia. SUMMARY: Respecting the vascularity of the anterior urethra and maintaining the integrity of surrounding structures during bulbar urethroplasty does not appear to deteriorate surgical outcomes and might be associated with improved functional outcomes.

Tissue N-linked glycosylation as potential prognostic biomarker for biochemical recurrence-free survival.

PURPOSE: Only few biomarkers have been evaluated for their prognostic value following radical prostatectomy. We explored if tissue N-glycosylation shows prognostic properties for biochemical recurrence (BCR)-free survival. MATERIALS AND METHODS: Tissue N-glycosylation profile was determined from 82 prostate cancer (PCa) patients and prognostic features were compared to clinical and biochemical parameters for BCR-free survival. RESULTS: Majority presented with Gleason score 3 + 4 (41%), extensive local disease (62%) and without pelvic lymph nodes invasion (83%). Several parameters (low T stage, low Gleason score, low EAU risk groups for BCR, absence of positive surgical margins, high ratio of fucosylated triantennary structures on total of multiantennary structures [3AFc/MA], low ratio of fucosylated biantennary with core-branched N-acetylglucosamine on total of biantennary structures, and high ratio of triantennary structures on total of multiantennary structures) proved to have a univariate beneficial effect on BCR-free survival. Multivariate analysis proved positive surgical margins and 3AFc/MA to be independent prognosticators. CONCLUSIONS: Tissue N-glycans are a powerful prognostic tool and can be an asset in PCa as the ratio of 3AFc/MA is independently associated with BCR-free survival. This could be of clinical use in guiding patients following radical prostatectomy, e.g. referral to adjuvant radiotherapy. Further elaboration of this biomarker is warranted.

Independent risk factors for failure after anterior urethroplasty: a multivariate analysis on prospective data.

PURPOSE: To identify independent risk factors for urethroplasty failure in a prospective dataset. METHODS: Since 2008, data of all male patients undergoing urethroplasty at Ghent University Hospital have been prospectively recorded and maintained. This analysis excluded: posterior strictures, strictures of the perineostomy, urethral malignancy-related strictures, age < 18 years and follow-up < 1 year. Postoperatively, a voiding cysto-urethrography (VCUG) was performed after 2 weeks and in absence of significant contrast extravasation, the transurethral catheter was removed. Patients were followed after 3 m, 12 m and annually thereafter. Failure was defined as stricture recurrence requiring additional urethral intervention(s). Uni- and multivariate Cox regression analyses were performed on the entire patient cohort and for one-stage urethroplasty (OSU) at specific locations. RESULTS: In total, 474 patients were included. Median follow-up was 62 m (IQR 35-91). Significant extravasation was present in 6.9%. Bulbar stricture location was identified as independent protective factor for urethroplasty failure (HR 0.44; p = 0.046) and significant extravasation at first VCUG was identified as independent risk factor for urethroplasty failure (HR 2.86; p = 0.005). Cox regression analyses for OSU at specific locations could not identify other risk factors. All but one (89%) of the failures preceded by significant extravasation at first VCUG occurred within 2 years of follow-up whereas 44% of the failures with no or insignificant extravasation at first VCUG occurred after 2 years of follow-up (p = 0.03). CONCLUSIONS: Bulbar stricture location is an independent protective factor for urethroplasty failure. Significant extravasation at first urethrography is an independent risk factor for urethroplasty failure and is associated with earlier stricture recurrence than other failed cases.

Second generation of temporary implantable nitinol device (iTind) in men with LUTS: 2 year results of the MT-02-study.

OBJECTIVES: Assessing medium-term functional results of a novel minimally-invasive treatment for lower urinary tract symptoms due to BPO with the second generation of the temporary implantable nitinol device (iTind; Medi-Tate Ltd®, Israel): 2-year follow-up of a single-arm, prospective, international multicenter study. Further, we aimed to identify preoperative baseline parameters predicting response to iTind treatment. METHODS: Following local ethical committee approval in every participating centre, 81 men with symptomatic BPO (IPSS ≥ 10, peak urinary flow < 12 ml/s, and prostate volume < 75 ml) were enrolled in this study. Patients with PVR > 250 ml, obstructive median lobe, previous prostatic surgery, confounding bladder or sphincter dysfunction based on medical history, active urinary infection and unable to interrupt antithrombotic or antiplatelet treatment were exclusion criteria. A wash-out period of 1 month for alpha-blockers and 6 months for 5-ARIs was mandatory to avoid confounders. The procedure was performed as previously described: implantation under light sedation and removal 5-7 days later with topical sedation. Patients were assessed for perioperative results including OR-time, pain (VAS) and complications (Clavien-Dindo-Grading System); and for functional results (PVR, Qmax, IPSS) and quality of life (QoL) including sexual and ejaculatory function using two yes/no questions. Follow-up assessments were done at 1, 3, and 6 months, and 1 and 2 years. RESULTS: Of the 81 patients initially enrolled in this study, follow-up included 67 men at 1 year and 51 men at 2 years. For the 51 men included in the present analysis, the median age was 65 years, median prostate volume 37 ml (range 16-65 ml). Baseline values for IPSS and QoL were 20.51 ± 4.58, 3.96 ± 0.87. Qmax and PVR were 7.62 ± 2.25 ml/s and 65.84 ± 38.46, respectively. No intraoperative complications were observed and the average pain level recorded on the visual analogue scale (VAS) was 3.2 ± 1.6. A significant reduction in symptoms and improvement in urinary flow was observed (p < 0.0001) at all assessment points: IPSS-score and QoL improved to 8.51 ± 5.51 and 1.76 ± 1.32, respectively; and Qmax increased to 16.00 ± 7.43 ml/s. None of the patients who were previously sexually active reported a deterioration in sexual or ejaculatory functions according to two yes/no questions over the follow-up period. Excluding the patients lost at follow-up, five patients underwent surgery between 12 and 24 months. Upon investigation, it was discovered that four of the five patients requiring surgery had median lobes and were protocol deviators. A failure analysis was carried out for all 81 patients in order to identify baseline parameters that could predict treatment failure. 58.33% of patients in the failure group (7 out of 12) had median lobes which was found to be statistically significant (p < 0.0001). None of the other preoperative variables (age, prostate volume, IPSS scores, Qmax, PVR, and PSA) were found to predict response to iTind treatment. CONCLUSION: iTind treatment for BPO-related LUTS showed marked and durable reduction in symptoms and improvement of functional parameters and quality of life at 24 months of follow-up. It was found that median lobe may predict failure of iTind treatment. According to the yes/no questions, ejaculatory and sexual functions do not seem to be effected following treatment, however, this finding must be supported with further studies using the accepted tools.

Hyperbaric oxygen therapy for radiation cystitis after pelvic radiotherapy: Systematic review of the recent literature.

The present study assessed the efficacy of hyperbaric oxygen therapy in reducing symptoms of radiation cystitis, a specific type of iatrogenic injury to the bladder, by systematic review of recent literature. The MEDLINE, Embase and Web of Science databases were searched using combinations of the terms "radiation," "cystitis" and "hyperbaric oxygen" to identify articles evaluating patients with radiation cystitis, treated with hyperbaric oxygen therapy. Only recent (≤10 years) original studies were included. Data were extracted and pooled in order to calculate descriptive weighted averages. Articles were evaluated on their level of evidence. A total of 20 papers were obtained, resulting in a cohort of 815 patients who were treated with hyperbaric oxygen therapy for radiation cystitis. Overall and complete response rates varied from 64.8% to 100% and 20% to 100%, respectively. The weighted average overall and complete response rates were 87.3% and 65.3%, respectively. Adverse events were observed in 9.6% of the patients, but permanent side-effects were rare. The most prominent limitations were high cost and low availability. Hyperbaric oxygen therapy is effective in the treatment of radiation-induced cystitis, with minimal adverse events, but low availability and high cost. At present, evidence is low; therefore, more prospective studies are required.

Patient- versus physician-reported outcomes in prostate cancer patients receiving hypofractionated radiotherapy within a randomized controlled trial.

PURPOSE: The risk of developing acute radiotherapy(RT)-induced side effects may increase with hypofractionated RT. To detect treatment-related side effects, patient-reported outcomes (PROs) might be more reliable than physician-reported outcomes. Therefore, we tried to evaluate the rate of agreement between urinary and gastrointestinal (GI) side effects and the prevalence of side effects reported by patients and by physicians. METHODS: Data from a randomized controlled trial (RCT) comparing two hypofractionated RT schedules were used. Urinary (nocturia, incontinence, frequency, dysuria, and urgency) and GI (obstruction, diarrhea, vomiting, nausea, bloating, hemorragia, and incontinence) symptoms measured by the EORTC QLQ-C30 and PR-25 were used for PROs. The same symptoms were scored by the physician using the Common Terminology Criteria Adverse Events v4.0. Outcomes were reported at baseline, end of treatment, month 1, and month 3. PROs and physician-reported outcomes were converted in two categories (0 = no symptoms; 1 = symptoms of any severity) and were correlated using the kappa (κ) correlation statistics. Values below 0.40 were considered low agreement. In addition, the prevalence of symptoms was calculated. RESULTS: Data from 160 patients were used. The mean value for Cohen's κ was 0.31 (ranging between 0.04 and 0.55) and 0.23 (ranging between 0.04 and 0.47) for urinary and GI symptoms, respectively. Except for three symptoms at baseline, all symptoms reported by patients were higher than those reported by physicians. CONCLUSION: There is low agreement between symptoms reported by patients and physicians, with high rates of underreporting by the physician.

Importance of metastatic volume in prognostic models to predict survival in newly diagnosed metastatic prostate cancer.

PURPOSE: To explore the prognostic importance of metastatic volume in a contemporary daily practice cohort of patients with newly diagnosed metastatic hormone-naive prostate cancer (mHNPC) and to develop a pragmatic prognostic model to predict survival for these patients. METHODS: Since 2014, 113 patients with newly diagnosed mHNPC were prospectively registered. Statistical analysis was performed using SPSS 25.0™ with two-sided p value < 0.05 indicating statistical significance. Univariate and multivariate cox regression analyses were performed to identify prognostic risk factors. Kaplan-Meier method with log-rank statistics was constructed to analyze difference in survival in the prognostic groups. Model performance was assessed using the Concordance-index (C-index) and cross-validated in R v3.4.1. High-volume mHNPC (HVD) was defined as the presence of visceral metastasis or ≥ 4 bone metastases with ≥ 1 appendicular lesion. RESULTS: Multivariate analysis identified HVD (p = 0.047) and elevated alkaline phosphatase (ALP) (p = 0.018) as independent prognostic risk factors for overall survival (OS). Consequently, three prognostic groups were created: a good (no risk factors), intermediate (1 risk factor) and poor prognosis group (2 risk factors). Median OS for the good, intermediate and poor prognosis group was not reached, 73 and 20 months (95% CI 9-31 months with p < 0.001 and Correspondence-index of 0.78), respectively. CONCLUSIONS: We developed a pragmatic and qualitative prognostic model consisting of three prognostic risk groups for OS in a daily practice cohort of patients with newly diagnosed mHNPC. Independent prognostic risk factors included in the model were HVD and abnormal ALP.

Discovery and validation of a serum microRNA signature to characterize oligo- and polymetastatic prostate cancer: not ready for prime time.

PURPOSE: Patients with oligometastatic prostate cancer (PC) may benefit from metastasis-directed therapy (MDT), delaying disease progression and the start of palliative systemic treatment. However, a significant proportion of oligometastatic PC patients progress to polymetastatic PC within a year following MDT, suggesting an underestimation of the metastatic load by current staging modalities. Molecular markers could help to identify true oligometastatic patients eligible for MDT. METHODS: Patients with asymptomatic biochemical recurrence following primary PC treatment were classified as oligo- or polymetastatic based on 18F-choline PET/CT imaging. Oligometastatic patients had up to three metastases at baseline and did not progress to more than three lesions following MDT or surveillance within 1 year of diagnosis of metastases. Polymetastatic patients had > 3 metastases at baseline or developed > 3 metastases within 1 year following imaging. A model aiming to prospectively distinguish oligo- and polymetastatic PC patients was trained using clinicopathological parameters and serum-derived microRNA expression profiles from a discovery cohort of 20 oligometastatic and 20 polymetastatic PC patients. To confirm the models predictive performance, it was applied on biomarker data obtained from an independent validation cohort of 44 patients with oligometastatic and 39 patients with polymetastatic disease. RESULTS: Oligometastatic PC patients had a more favorable prognosis compared to polymetastatic ones, as defined by a significantly longer median CRPC-free survival (not reached versus 38 months; 95% confidence interval 31-45 months with P < 0.001). Despite the good performance of a predictive model trained on the discovery cohort, with an AUC of 0.833 (0.693-0.973; 95% CI) and a sensitivity of 0.894 (0.714-1.000; 95% CI) for oligometastatic disease, none of the miRNA targets were found to be differentially expressed between oligo- and polymetastatic PC patients in the signature validation cohort. The multivariate model had an AUC of 0.393 (0.534 after cross-validation) and therefore, no predictive ability. CONCLUSIONS: Although PC patients with oligometastatic disease had a more favorable prognosis, no serum-derived biomarkers allowing for prospective discrimination of oligo- and polymetastatic prostate cancer patients could be identified.