Disposable grasper-integrated flexible cystoscope for ureteral stent removal in transplanted patients; focus on feasibility, safety, and patient experience. Results and micro-cost analysis from a tertiary referral center.

INTRODUCTION & OBJECTIVES: To evaluate ureteral stent removal (SR) using a grasper-integrated disposable flexible cystoscope (giFC-Isiris ®, Coloplast ®) after kidney transplantation (KT), with a focus on feasibility, safety, patient experience, and costs. MATERIAL AND METHODS: All consecutive KT undergoing SR through giFC were prospectively enrolled from January 2020 to June 2023. Patient characteristics, KT and SR details, urine culture results, antimicrobial prescriptions, and the incidence of urinary tract infections (UTI) within 1 month were recorded. A micro-cost analysis was conducted, making a comparison with the costs of SR with a reusable FC and grasper. RESULTS: A total of 136 KT patients were enrolled, including both single and double KT, with 148 stents removed in total. The median indwelling time was 34 days [26, 47]. SR was successfully performed in all cases. The median preparation and procedure times were 4 min [3,5]. and 45 s[30, 60], respectively. The median Visual Analog Scale (VAS) score was 3 [1, 5], and 98.2% of patients expressed willingness to undergo the procedure again. Only one episode of UTI involving the graft (0.7%) was recorded. Overall, the estimated cost per SR procedure with Isiris ® and the reusable FC was 289.2€ and 151,4€, respectively. CONCLUSIONS: This prospective series evaluated the use of Isiris ® for SR in a cohort of KT patients, demonstrating feasibility and high tolerance. The UTI incidence was 0.7% within 1 month. Based on the micro-cost analysis, estimated cost per procedure favored the reusable FC.

Patients undergoing double J substitution with a pigtail suture stent report a significant decrease of stent-related symptoms. Results from a prospective multicenter longitudinal trial.

PURPOSE: To compare stent-related symptoms (SRS) in patients with double J (DJ) undergoing substitution with a pigtail suture stent (PSS) after ureteroscopy (URS), through the Ureteral Stent Symptom Questionnaire (USSQ). MATERIALS AND METHODS: Patients with DJ undergoing URS for stone treatment were enrolled in this prospective multicenter longitudinal study. The USSQ was submitted thrice: 2 weeks after DJ, 2 weeks after PSS and 4 weeks after PSS removal (baseline). PRIMARY ENDPOINT: to compare Urinary Symptom Index Score and the rate of patients with pain 2 weeks after DJ and PSS. Secondary endpoints: to compare other USSQ scores and single answers 2 weeks after DJ and PSS, and DJ and PSS USSQ scores with baseline. RESULTS: 93 patients were enrolled. 2 weeks Urinary Symptom Index Score (p < 0.001) and the percentage of patients complaining of pain (60.2% vs 88.2%, p < 0.001) were significantly in favour of PSS compared to DJ. 2 weeks scores were significantly improved with PSS compared to DJ: Pain Index (p < 0.001), VAS (p < 0.001), General Health Index (p < 0.001) and Work Performance Index (p < 0.001). All urinary symptoms were significantly decreased with PSS, including renal pain during micturition and pain interfering with life. Pain Index Score (p = 0.622) and VAS (p = 0.169) were comparable to baseline with PSS, while differed with DJ. CONCLUSIONS: Patients undergoing DJ substitution with PSS after URS report a significant decrease of SRS. Urologists may consider positioning PSS after URS in pre-stented patients to reduce the impact of SRS.

Single-use digital flexible cystoscope for double J removal versus reusable instruments: a prospective, comparative study of functionality, risk of infection, and costs.

BACKGROUND: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. METHODS: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. RESULTS: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. CONCLUSIONS: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found.

Trans - Perineal laser ablation of the prostate in high surgical risk patients affected by severe lower urinary tract symptoms related to benign prostatic obstruction.

BACKGROUND: In our study, we aimed to test the efficacy and safety of Trans-Perineal Laser Ablation of the prostate (TPLA®) in the surgical treatment of high-risk Benign Prostatic Obstruction (BPO) patients. METHODS: We defined a high-risk BPO patient as an elderly man affected by severe comorbidities, among which coagulation issues due to pre-existent medications or diseases. From October 2020 to June 2022, we prospectively enrolled high-risk patients affected by a moderate to severe and/or complicated BPO condition. The analysis of the efficacy of the Trans-Perineal Laser Ablation was defined as the primary endpoint of the study. Secondary endpoints were post-operative surgical complications and patient-reported quality of life. RESULTS: Globally, 40 consecutive patients were enrolled. Median (IQR) age was 80 (72.5-84) years. Median Charlson Comorbidity Index was 6 (5-7). Median prostate volume was 38 (30.5-73) cc. In all cases, a TPLA® procedure was performed under local anesthesia, and patients being discharged within the same day of the procedure. A progressive reduction of median prostate volumes was reported at 3 and 6 months post-operatively, compared to baseline [38 (30.5-73) vs 35 (26-49) vs 34 (28-49) cc, p < 0.001]. Median International Prostate Symptom Score (IPSS) improved accordingly [25 (19-30) vs 10.5 (7.5-13) vs 8 (6-11.5), p < 0.001]. A permanent bladder catheter was successfully removed in 13 out of 23 (56.5%) cases. Within 90 days from surgery, 19 (47.5%) patients experienced at least one surgical complication. According to the Clavien-Dindo classification, complications were classified as grade I in 16 (40%) cases, grade II in 9 (22.5%), and grade III in 1 (2.5%). We did not observe any grade IV or V complications. CONCLUSIONS: The Trans-Perineal Laser Ablation of the Prostate is a feasible, safe, and effective Minimally Invasive Surgical Technique, when offered to elderly, high-risk patients affected by severe Benign Prostatic Obstruction.

Ejaculation physiology and dysfunction after BPH surgery: the role of the new MISTs.

BACKGROUND: Human ejaculation can be defined as a complex and still largely unknown function. Since decades, Benign Prostatic Hyperplasia (BPH) surgery-associated loss of antegrade ejaculation has been reported as a bother by many patients. New technologies and modified surgical techniques were developed, to reduce the impact of ejaculatory dysfunction on patients' perceived quality of life. Recently, the emerging of the new Minimally Invasive Surgical Techniques (MISTs) empowered the urological surgeons with the technological means to introduce the ejaculation-sparing principles into everyday clinical practice. METHODS: Our paper was conceived as a state-of-the-art analysis about the anatomical and physiological premises of the human ejaculation and their clinical application in the field of ejaculation-sparing surgery for the treatment of Lower Urinary Tract Symptoms (LUTS). Moreover, we proposed an innovative physiological model for antegrade ejaculation. RESULTS: We analysed the elements of the "ejaculatory apparatus" from an anatomical point of view. We investigated the physio-pathological models of the human ejaculation, from the classical "combustion chamber" paradigm to the new evidences by which it could be overcome. Finally, we provided a synthetic literature review about the ejaculation-sparing techniques for BPH surgery. Particularly, we distinguished them between classical techniques, modified for ejaculation-preserving purposes, and the new MISTs, characterized by the introduction of new technologies and different treatment modalities. CONCLUSIONS: Modified surgical techniques and new technologies opened new perspectives about human ejaculation. Previously established functional paradigms were questioned and overcome by recent clinical evidence. The new MISTs gained a prominent role in the process, opening a whole new era for BPH surgery.

Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones ≤2 cm: A Randomized Controlled Trial.

BACKGROUND: No clear recommendations are available on whether retrograde intrarenal surgery (RIRS) via flexible ureterorenoscopy or shockwave lithotripsy (SWL) should be preferred for kidney stones ≤2 cm, except for lower-pole stones. OBJECTIVE: To compare outcomes between RIRS and SWL. DESIGN, SETTING, AND PARTICIPANTS: This was a single-center randomized controlled trial from March 2015 to May 2018. Patients with a single 6-20-mm kidney stone were enrolled (NCT02645058). INTERVENTION: Patients were randomized to RIRS or SWL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the single-procedure stone-free rate (SFR) at 1 mo. Two levels of success were set: fragments ≤4 mm (SFR-4) and no residual fragments (SFR-0). Secondary endpoints were the SFR at 6 mo and 1 yr and rates of complications and further treatments. RESULTS AND LIMITATIONS: A total of 138 patients underwent treatment (70 RIRS vs 68 SWL). In comparison to SWL, RIRS SFR results were higher at 1 mo (SFR-4 70.0% vs 45.6%; p = 0.004; SFR-0 50.0% vs 26.5%; p = 0.004) and 6 mo (SFR-4 79.7% vs 63.6%; p = 0.038; SFR-0 59.4% vs 40.9%; p = 0.032). There was no difference in SFR measures between the groups at 1 yr (SFR-4 p = 0.322; SFR-0 p = 0.392). Overall complications were comparable (p = 0.207), but the complication rate for stones >10 mm was higher for the SWL group (p = 0.021). The need for further treatment was comparable (p = 0.368). In terms of patient satisfaction, 86.8% and 77.1% of patients would choose SWL and RIRS again, respectively (p = 0.24). CONCLUSIONS: RIRS achieved better SFRs in comparison to SWL at 1 and 6 mo, but not at 1 yr. The RIRS complication rate was lower for stones >10 mm. SWL remains a viable alternative, especially for 6-10-mm stones, providing comparable results to RIRS in the long term. PATIENT SUMMARY: We compared outcomes for the treatment of kidney stones ≤2 cm with two techniques: flexible ureteroscopy, in which a flexible telescope is passed through the urethra and bladder to reach the ureter between the bladder and kidney; and shockwave lithotripsy, in which shockwaves are applied to the skin over the location of the kidney stone. Ureteroscopy achieved better stone-free results at 1 and 6 months, but not at 1 year.

COVID-19 pandemic impact on uro-oncological disease outcomes at an Italian tertiary referral center.

PURPOSE: To assess differences in referral and pathologic outcomes for uro-oncology cases prior to and during the COVID pandemic, comparing clinical and pathological data of cancer surgeries performed at an academic referral center between 2019 and 2020. METHODS: We collected data of 880 prostate biopsies, 393 robot-assisted radical prostatectomies (RARP) for prostate cancer (PCa), 767 trans-urethral resections of bladder tumor (TURB) and 134 radical cystectomies (RC) for bladder cancer (BCa), 29 radical nephro-ureterectomies (RNU) for upper tract urothelial carcinoma, 130 partial nephrectomies (PN) and 12 radical nephrectomies (RN) for renal cancer, and 41 orchifunicolectomies for testicular cancer. Data of patients treated in 2019 (before COVID-19 pandemic) were compared to patients treated in 2020 (during pandemic). RESULTS: No significant decline in uro-oncological surgical activity was seen between 2019 and 2020. No significant increase in time between diagnosis and surgery was observed for all considered cancers. No differences in terms of main pathologic features were observed in patients undergoing RARP, TURB, RNU, RN/PN, or orchifunicolectomy. A higher proportion of ISUP grade 3 and 4 PCa were diagnosed in 2020 at biopsy (p = 0.001), but this did not translate into worse pathological grade/stage at RARP. In 2020, more advanced disease features were seen after RC, including lymph node involvement (p = 0.01) and non-organ confined disease (p = 0.02). CONCLUSION: Neither decline in uro-oncologic activity nor delay between diagnosis and treatment was observed at our institution during the first year of COVID-19 pandemic. No significant worsening of cancer disease features was found in 2020 except for muscle-invasive BCa.

Loop-tail stents fail in reducing stent-related symptoms: results of a prospective randomised controlled trial.

OBJECTIVE: To compare stent-related symptoms (SRS) of loop-tail (LT) and conventional double J (DJ) stents after uncomplicated flexible ureterorenoscopy (fURS), in a prospective randomised controlled single-blind parallel-group study. PATIENTS AND METHODS: Patients undergoing fURS were randomised into two groups: the LT Group received LT stents (Polaris™ Loop) and the DJ Group received conventional DJ stents (Vortek® ). The stent was removed after 4 weeks. The Ureteric Stent Symptom Questionnaire (USSQ) was administered at 2 days, 4 and 8 weeks (baseline evaluation) after stent insertion. The primary endpoint was to compare the Urinary Symptom Index Score of the LT vs DJ groups at 4 weeks after stent insertion. The secondary endpoints were to compare the USSQ domains' subscores at 2 days and 4 weeks after stent insertion, USSQ single answers at 4 weeks, and the 4-week USSQ domains' subscores adjusted for baseline. RESULTS: A total of 68 patients were randomised (34 LT and 34 DJ). The answers given at 4 weeks were not significantly different between the two groups for the Urinary Symptom Index Score (P = 0.982), Pain Index Score (P = 0.169), visual analogue scale (P = 0.276), and all the other domains of the USSQ. At 4 weeks, the single-answer analysis did not find any differences between the groups; the urinary symptoms were all comparable, as was the requirement for pain painkillers (P = 0.684) and pain during sex (P = 0.496). There were also no significant differences for every single domain score for the responses given at 2 days. The same applied to USSQ subscores at 4 weeks adjusted for the 8-week baseline results, which were also comparable. CONCLUSIONS: The study found no differences in terms of SRS between the LT and DJ groups, either at 2 days or 4 weeks after stent insertion, with or without baseline correction.

Flexible Ureterorenoscopy under Spinal Anesthesia: Focus on Technique, Results, Complications, and Patients' Satisfaction from a Large Series.

INTRODUCTION: Although spinal anesthesia (SA) may reduce postoperative morbidity, most urologists perform flexible ureterorenoscopy (fURS) under general anesthesia (GA). The objective of our study is to provide technical details, results, complications, and patients' satisfaction with fURS performed under exclusive SA. METHODS: We analyzed all consecutive fURS performed under SA to treat renal stones from March 2011 to February 2017. Details of technique, operative time, outcomes, need for further treatments, complications, and patients' satisfaction were evaluated. RESULTS: Two hundred thirty-four fURS under SA were considered. SA was performed through L2-L3 vertebral interspace in 64.1%. Patients were discharged the same day of surgery. Mean stone burden was 13.5 ± 6.6 mm and mean operative time 76.9 ± 34.6 min. Single-procedure SFR was 69.7%. Further treatments were performed in 22.8%. 96.6% had no anesthesia-related complications. No Clavien-Dindo grade ≥ IIIb complications were noticed. 99.6% of patients were satisfied with SA. No cases of conversion from SA to GA occurred. CONCLUSION: fURS can be performed safely and efficiently under SA, taking into account a few details of the technique. Patients' satisfaction with SA is very high, and complications are rare. Although SA is usually adopted in unfit patients for GA, it may be considered as a viable alternative in fit patients.

Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial.

BACKGROUND: Double J (DJ) ureteral stents are commonly inserted after ureteroscopy (URS) procedures for stone treatment. However, stent-related symptoms are still a major issue. OBJECTIVE: To determine whether a commercially available pigtail suture stent (PSS) can reduce stent-related symptoms compared to a conventional DJ stent after uncomplicated URS. DESIGN SETTING AND PARTICIPANTS: We designed a randomized, single-blind, parallel-group trial from January to November 2020. The inclusion criteria were stone-free URS without intraprocedural complications. Patients with distal ureteral stones were excluded. INTERVENTION: Insertion of a PSS or DJ stent after URS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the Urinary Symptom Index score on the Ureteral Stent Symptoms Questionnaire (USSQ) 2 wk after URS. Secondary endpoints were USSQ domain scores and responses to individual USSQ questions at 2 d and 2 wk after surgery. RESULTS AND LIMITATIONS: A total of 78 patients were randomized and treated according to protocol. The Urinary Symptom Index score (p = 0.004), overall Visual Analogue Scale (VAS) score (p = 0.022), and the percentage of patients complaining of pain (63.9% vs 86.1%, p = 0.029) were significantly in favor of PSS at both 2 d and 2 wk after URS. At 2 d, the VAS score among patients with pain (p = 0.025) and the General Health Index score (p = 0.036) were significantly better in the PSS group. No severe complications occurred in either group. Study limitations are the exclusion of patients with distal ureteral stones and the limited sample size. CONCLUSIONS: PSS significantly reduced stent-related symptoms after URS, in particular urinary symptoms and pain, compared to conventional DJ stents, and showed a good safety profile. PATIENT SUMMARY: Stents are hollow tubes placed in the passage between the kidney and the bladder (ureter). The standard stent has two coiled ends (double J stent) to keep it in place in both the kidney and the bladder. We tested a commercial stent with two strings at the bladder end (pigtail suture stent) after procedures to remove stones from the upper urinary tract and found that it caused less stent-related symptoms compared to a double J stent.This trial is registered at Clinicaltrials.gov as NCT03344120.

Ejaculation-sparing versus non-ejaculation-sparing anatomic GreenLight laser enucleo-vaporization of the prostate: first comparative study.

PURPOSE: To present the step-by-step description of an ejaculation-sparing anatomic photo-selective vaporization of the prostate (PVP) technique. To report the results of a series of ejaculation-sparing versus non-ejaculation-sparing anatomic PVPs. METHODS: Sexually active, benign prostatic hyperplasia (BPH) patients undergoing an anatomic PVP between 11/2018 and 2/2020 were included. Patients were divided into group A (ejaculation-sparing surgery) and group B (control group). Baseline, peri-operative and 6-months follow-up data were evaluated. Lower urinary tract symptoms (LUTS) and sexual function were assessed through internationally validated questionnaires. Groups were matched by an inverse probability of treatment weighting (IPTW) analysis. Logistic univariable regression analysis was performed to detect predictors of antegrade ejaculation preservation. RESULTS: Overall, 76 patients were included, among which 15 in group A and 61 in group B. Median (inter-quartile range, IQR) age was 72 (66.5-77) years, median (IQR) prostate volume 63.5 (54.5-98.5) cc. No differences about peri-operative outcomes were detected, included high-grade complications. At 6-months follow-up, no differences in urinary or erectile function were detected between groups, while ejaculation-sparing patients showed better Male Sexual Health Questionnaire (MSHQ) scores [7 (1-13) vs. 1 (1-1), p < 0.001] and higher rates of antegrade ejaculation (60% vs. 13.1%, p < 0.001). The ejaculation-sparing technique was identified as a predictor of post-operative antegrade ejaculation (OR 19.3, CI 95% 7.2-51.2, p < 0.001). CONCLUSION: The ejaculation-sparing anatomic PVP showed superiority over the control group in post-operative ejaculatory function scores and antegrade ejaculation rates. Besides, preliminary results suggested similar effectiveness in LUTS relief at a short-term follow-up.