A novel less-traumatic needle for kidney puncture: first clinical experience.

INTRODUCTION: To decrease complication rate, we developed a novel MG needle for kidney puncture consisting of a pointed cannula, an atraumatic mandrin-bulb and a spring mechanism pushing the mandrin-bulb forward. AIM OF THE STUDY: To assess efficacy and safety of kidney puncture during percutaneous nephrolithotomy (PCNL) using a novel less-traumatic MG needle within a clinical trial. MATERIALS AND METHODS: We conducted a prospective randomized single-center study. In the experimental group, kidney puncture was performed with a novel MG needle while in the control group, standard Trocar or Chiba puncture needles were used. PRIMARY ENDPOINT: hemoglobin drop. RESULTS: A total of 67 patients were enrolled. Patients who underwent standard puncture (n = 33) had higher hemoglobin drop in the early postoperative period (p = 0.024). Although there was no statistical difference in overall complication rate between the two groups (p = 0.351), two severe Clavien-Dindo IIIa complications with urinoma occurred in patients from the control group. CONCLUSION: Less-traumatic needle for kidney puncture may reduce hemoglobin drop and prevent the development of severe complications. At the same time, in terms of stone-free rate (SFR), the efficacy of PCNL remains the same regardless of the needle used for renal access.

A Novel and Less Traumatic Needle for Kidney Puncture: Development and Preclinical Study Results.

Abstract Introduction: A considerable proportion of percutaneous nephrolithotomy complications occurs during renal puncture. An option to decrease the complications rate is needle modification to make the procedure less traumatic. We aimed to evaluate the effectiveness of the novel MG needle in a preclinical study. Materials and Methods: We developed an original MG needle based on the Veress needle concept containing an atraumatic (blunt) mandrin connected through a spring to the cannula. The MG needle's properties were compared with those of the conventional Chiba and Trocar needles in two experiments. In the first experiment, we assessed the force required to puncture the model. In the second experiment, we punctured a porcine kidney and analyzed histology report after the puncture. Results: We performed a series of 30 punctures of polypropylene block by each needle. The force required to make a puncture with the Chiba needle (6.53 ± 0.87 N) was significantly lower compared with the MG needle (7.1 ± 1.07 N), p = 0.027. However, the MG needle turned out to be superior to the Trocar needle (8.71 ± 1.08 N), p = 0.001. A total of 15 specimens were obtained after three renal punctures were made with each needle. A microscopy of the specimen after puncture with the Chiba and Trocar needles showed small fragments of epithelium and erythrocytes inside the canal with uneven margins where the needle passed. A microscopy of the specimen after puncture with a novel MG needle showed a canal with even margins. No tissue fragments inside the canal were observed. Conclusion: The force required to puncture with the novel MG needle is comparable with conventional needles. According to preclinical experiments, histology report of porcine kidney indicates that renal puncture with an MG needle is less traumatic. It may reduce the risk of bleeding, and this should be proved during clinical trials.

EAU, AUA and NICE Guidelines on Surgical and Minimally Invasive Treatment of Benign Prostate Hyperplasia: A Critical Appraisal of the Guidelines Using the AGREE-II Tool.

OBJECTIVE: To critically appraise the methodological rigour of the clinical practice guidelines (CPGs) vis-à-vis BPH surgery as used by specialist research associations in the US, Europe and UK, and to compare whether the guidelines cover all or only some of the available treatments. METHODS: The current guidelines issued by the EUA, AUA and NICE associations have been analyzed by 4 appraisers using the AGREE-II instrument. We also compared the recommendations given in the guidelines for surgical and minimally invasive treatment to find out which of these CPGs include most of the available treatment options. RESULTS: According to the AGREE II tool, the median scores of domains were: domain 1 scope and purpose 66.7%, domain 2 stakeholder involvement 50.0%, domain 3 rigor of development 65.1%, domain 4 clarity of presentation 80.6%, domain 5 applicability 33.3%, domain 6 editorial independence 72.9%. The overall assessment according to AGREE II is 83.3%. The NICE guideline scored highest on 5 out of 6 domains and the highest overall assessment score (91.6%). The EAU guideline scored lowest on 4 out of 6 domains and has the lowest overall assessment score (79.1%). CONCLUSIONS: The analyzed CPGs comprehensively highlight the minimally invasive and surgical treatment options for BPH. According to the AGREE II tool, the domains for clarity of presentation and editorial independence received the highest scores. The stakeholder involvement and applicability domains were ranked as the lowest. Improving the CPG in these domains may help to improve the clinical utility and applicability of CPGs.

Thulium-fiber laser for lithotripsy: first clinical experience in percutaneous nephrolithotomy.

PURPOSE: To evaluate the efficacy and safety of thulium-fiber laser (TFL) in laser lithotripsy during percutaneous nephrolithotomy (PCNL). METHODS: Patients with stones < 30 mm were prospectively recruited to undergo PCNL using TFL "FiberLase" (NTO IRE-Polus, Russia). Stone size, stone density, operative time, and "laser on" time (LOT) were recorded. Study included only cases managed with fragmentation. Stone-free rate and residual fragments were determined on postoperative computer tomography. Complications were classified using the Clavien-Dindo grade. Stone retropulsion and endoscopic visibility were assessed based on surgeons' feedback using a questionnaire. RESULTS: A total of 120 patients were included in the study with a mean age of 52 (± 1.8) years; of these 77 (56%) were males. Mean stone size was 12.5 (± 8.8) mm with a mean density of 1019 (± 375) HU. Mean operative time was 23.4 (± 17.9) min and mean LOT was 5.0 (± 5.7) min. Most used settings were of 0.8 J/25-30 W/31-38 Hz (fragmentation). The mean total energy for stone ablation was 3.6 (± 4.3) kJ. Overall stone-free rate was 85%. The overall complication rate was 17%. Surgeons reported stone retropulsion that interfered with surgery in 2 (1.7%) cases insignificant retropulsion was noted in 16 (10.8%) cases. Poor visualization was reported in three (2.5%) cases and minor difficulties with visibility in four (3.3%) cases. CONCLUSIONS: TFL is a safe and effective modality for lithotripsy during PCNL and results in minimal retropulsion.

Buried Penis Surgical Correction: Midline Incision Rotation Flaps.

OBJECTIVE: To improve cosmetic and functional results of buried penis correction in boys using a modified universal surgical approach - Midline Incision Rotation Flaps. MATERIALS AND METHODS: We retrospectively analyzed results of 18 patients who underwent buried penis surgical treatment according to the Midline Incision Rotational Flaps technique from 2013 to 2016. The results were assessed by the surgeon 1, 3, 6 months after surgery, then yearly. Parents filled out postoperative survey after 1 month. The surgery commences with a midline longitudinal skin incision on the ventral surface. Following, a circumferential incision along the coronal edge allows to perform full degloving. Excessive subcutaneous fat tissues are removed from the peno-pubic area. Next stage is the formation of the peno-scrotal and peno-pubic angles by fixation of the skin at the base of the penis. Then, the edges of the skin flaps are opened, forming Byar's flaps. The skin defect along the ventral surface is covered with rotated triangular skin flaps with nourishing vessels. Uneven excessive skin is dissected and interrupted skin sutures are placed. RESULTS AND DISCUSSION: The median age of patients was 1.4 years with a median follow-up of 56 months (range 36-72). 16 patients (89%) obtained good results, and 2 patients (11%) - satisfactory. The results showed that size and appearance are close to natural and satisfying to parents of the patients. CONCLUSION: The suggested method of buried penis repair using Midline Incision Rotation Flaps technique allows to obtain the most satisfactory both cosmetic and functional results with minimal complication risk.

Bracka's Method of Proximal Hypospadias Repair: Preputial Skin or Buccal Mucosa?

OBJECTIVE: To analyze treatment results of staged surgical repair of proximal forms of hypospadias according to Bracka's technique using preputial vs buccal grafts. MATERIAL AND METHODS: We retrospectively reviewed 220 patients with proximal forms of hypospadias treated with Bracka's urethroplasty technique. They were divided into 2 groups: Group I-108 patients treated with preputial skin grafts in 2001-2013; Group II-112 patients who underwent urethroplasty with buccal mucosa grafts in 2013-2016. RESULTS AND DISCUSSION: Of the Group I patients with preputial skin grafts, complications were obtained in 33 (31%) cases; in Group II-23 (20%) cases. Complications include fistulas, defects of urethra, and scar contraction of grafts. The cosmetic results according to Hypospadias Objective Penile Evaluation scale were more satisfactory when buccal mucosa grafts were used. Further studies are needed to analyze the long-term changes posturethroplasty with both preputial skin and buccal mucosa grafts. CONCLUSION: This is one of the only studies to compare complications and histology of the 2 free grafts: preputial skin and buccal mucosa. This study affirms that a staged surgical method with the use of free grafts according to Bracka's technique is a successful method of treatment of proximal forms of hypospadias in children achieving good functional and cosmetic results with a relatively low rate of complications.

Monopolar enucleation versus transurethral resection of the prostate for small- and medium-sized (< 80 cc) benign prostate hyperplasia: a prospective analysis.

AIM: To assess efficacy and safety of monopolar enucleation of the prostate (MEP) and to compare it with the current treatment standard for medium-sized prostates, < 80 cc, transurethral resection of the prostate (TURP). METHODS: A prospective analysis patients undergoing a surgical procedure for their diagnosis of BPH (benign prostatic hyperplasia) (IPSS > 20, Qmax < 10; prostate volume < 80 cc) was performed. IPSS, Qmax were assessed preoperatively, at 6 and 12 months postoperatively. The complications were classified according to the modified Clavien-Dindo grading system. RESULTS: A total of 134 patients were included in the study: 70 underwent MEP and 64 - TURP for BPH (mean prostate volumes were comparable with p = 0.163). The mean surgery time was 44 min in the TURP group and 48.2 min in the MEP group, (p = 0.026). Catheterization time for MEP was 1.7 and 3.2 days for TURP (p < 0.001). Hospital stay for MEP was 3.2 days vs. 4.8 days for TURP (p < 0.001). Both techniques shown comparable efficiency in benign prostatic obstruction relief with IPSS drop in MEP from 23.1 to 5.9 and in TURP group from 22.8 to 7.3, whereas Qmax increased from 8.2 to 20.5 after MEP and from 8.3 and 19.9 after TURP. Urinary incontinence rate after catheter removal in TURP group was 9.0% and 7.8% in MEP group, at 1 year follow-up, it was 1.4% and 3.1% in MEP and TURP, respectively (p = 0.466). CONCLUSIONS: Our experience demonstrated that MEP is an effective and safe BPH treatment option combining the efficacy of endoscopic enucleation techniques and accessibility of conventional TURP.

Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate.

OBJECTIVE: To compare the efficacy and safety of a novel thulium fiber laser for endoscopic enucleation of the prostate with monopolar transurethral resection of the prostate in patients with smaller glands (<80 cc). METHODS: A total of 51 patients underwent thulium fiber laser enucleation of the prostate, and 52 patients underwent monopolar transurethral resection of the prostate. All patients were assessed preoperatively, and at 3, 6, and 12 months postoperatively (International Prostate Symptom Score, maximum urine flow rate, International Prostate Symptom Score-quality of life). Preoperative prostate volumes and prostate-specific antigen levels were comparable (P = 0.543 and P = 0.078, respectively). The complications were graded according to the Clavien classification. RESULTS: Mean surgery time was longer in the thulium fiber laser enucleation of the prostate group (46.6 ± 10.2 vs 39.9 ± 8.6 min, P < 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001). At 12 months, there were no differences in functional outcomes (International Prostate Symptom Score, maximum urine flow rate). Despite comparable prostate volumes at 12 months (P = 0.864), the prostate-specific antigen level in the thulium fiber laser enucleation of the prostate group (0.5 ± 0.5 ng/mL) was lower than in the transurethral resection of the prostate group (1.1 ± 1.0 ng/mL; P < 0.001). Hemoglobin and serum sodium decrease was lower in the thulium fiber laser enucleation of the prostate group (1.01 ± 0.4 g/dL and 1.1 ± 1.1 mmol/L) than in the transurethral resection of the prostate group (1.8 ± 0.8 g/dL and 4.1 ± 1.1 mmol/L; P < 0.001). Urinary incontinence rates at 12 months were comparable (P = 0.316). CONCLUSIONS: Thulium fiber laser enucleation of the prostate with novel thulium fiber laser in patients with smaller prostate glands (<80 cc) is comparable to transurethral resection of the prostate in voiding parameters improvement and complication rates. At the same time, the technique allows for a more substantial prostate-specific antigen decrease, indicating more complete removal of adenoma.

A Randomized Trial Comparing The Learning Curve of 3 Endoscopic Enucleation Techniques (HoLEP, ThuFLEP, and MEP) for BPH Using Mentoring Approach-Initial Results.

OBJECTIVE: To assess the differences in the learning curve associated with different techniques of endoscopic enucleation of the prostate. MATERIALS AND METHODS: Ninety patients were randomly assigned into 3 groups (30 patients in each): HoLEP, ThuFLEP or MEP. Inclusion criteria for the study included prostate volume <80 cc, IPSS > 20, or Qmax < 10. The EEPs were performed by 3 surgeons experienced in transurethral resection of the prostate. Assignment of surgeons to surgical technique was also randomized. None of the surgeons had prior experience in EEP. RESULTS: ThuFLEP was slightly superior (with no significant difference [P > .05]) to HoLEP and MEP in terms of overall enucleation rate-1.0 g/min vs 0.8 g/min and 0.7 g/min, respectively. We observed similar enucleation rates at the initial stages of training (first 20 surgeries) with insignificant increase in ThuFLEP efficiency. At next 10 surgeries ThuFLEP and HoLEP efficiency were higher than of MEP (P < .001) without significant difference between techniques of laser EEP (P = .07). CONCLUSION: Endoscopic enucleation of the prostate can be adopted safely and effectively within 30 surgeries if the technique is learned with a mentoring approach. EEP is shown to be safe and effective even in the initial stages of learning. Laser EEP (HoLEP, ThuFLEP) appears to lend itself to quicker adaptation compared MEP.