bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Pure Bipolar Plasma Vaporization of the Prostate: Results from a Prospective 3D Ultrasound Volumetry Study with Clinical Outcome After 3 Years.

INTRODUCTION AND OBJECTIVES: Bipolar plasma vaporization (BPV) has been shown to be a low-morbidity alternative to conventional transurethral resection of the prostate (TURP). Improved functional short-term outcome and a postoperative prostate volume reduction comparable to TURP have been reported. However, comprehensive mid- or long-term results following BPV are still lacking. METHODS: A consecutive series of men who underwent pure BPV in a tertiary care academic center was prospectively investigated. Clinical parameters [International Prostate Symptom Score with Quality-of-Life domain, peak urinary flow rate (Qmax), postvoid residual volume, and prostate-specific antigen] as well as prostate volume (assessed by planimetric volumetry following transrectal 3D-ultrasound) were recorded preoperatively and regularly after BPV (after catheter removal, 6 weeks, 6 months, 1 year, and 3 years). Statistical analysis was performed using the Wilcoxon signed-rank test. All p-values ≤0.05 were considered significant. RESULTS: Seventy-five men were included in this prospective investigation. Their median (interquartile range) prostate volume was 41.0 mL (30.6-57.4 mL). In the first year after BPV, the prostate volume continuously decreased over time and the relative volume reduction was 52.2% after 12 months. Subsequently, the volume reduction remained stable with 50.7% after 3 years. All investigated outcome parameters improved significantly after the procedure and remained so after 3 years. Reoperations due to persistent or regrown adenoma were not necessary. Six (8.0%) and five patients (6.6%) developed a de novo urethral stricture or bladder neck contracture, respectively. CONCLUSIONS: Three years after pure BPV of the prostate, a durable prostate volume reduction in combination with a stable improvement of functional outcome parameters was detectable in our prospective study. The low morbidity of the procedure and the possibility to perform BPV under ongoing platelet aggregation inhibition confirms its role as minimally invasive alternative to conventional TURP.

Prostate volume reduction following pure transurethral bipolar plasma vaporization and conventional transurethral resection of the prostate: a prospective investigation using transrectal 3D ultrasound volumetry.

PURPOSE: To evaluate and compare postoperative changes in prostate volume and clinical outcome after bipolar plasma vaporization (BPV) and conventional transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Consecutive series of patients undergoing BPV or TURP were included in this prospective, nonrandomized study. Planimetric volumetry after transrectal three-dimensional ultrasound of the prostate was performed preoperatively and postoperatively after 6 weeks, 6 months and 12 months. Additionally, changes in clinical outcome parameters were assessed and compared between the groups. The reduction ratio and analysis of covariance were used to compare volume changes between BPV and TURP. Multiple regression analysis was performed to assess a possible interaction between preoperative prostate volume and effect of therapy. RESULTS: A total of 157 patients were included (BPV: n = 68, TURP: n = 89). Median preoperative prostate volume was 43.1 ml in the BPV group and 45.9 ml in the TURP group (p = 0.43). Postoperatively, the prostate volumes decreased significantly in both groups. After catheter removal, the relative residual prostate volume was significantly higher in the BPV group (66.6 vs. 60.8 %; p = 0.02). Thereafter, significant differences were not detectable anymore (12 months: 46.6 vs. 47.1 %; p = 0.82). Regression analysis revealed that tissue ablation after BPV was superior to TURP in prostates <45 ml but inferior in prostates >45 ml. All clinical outcome parameters improved significantly and were not significantly different between the groups. CONCLUSIONS: Volume reduction and short-term clinical outcome following pure BPV was excellent and comparable to conventional TURP. However, volume reduction seems to be limited in patients with larger prostates.

Ablative efficiency of 532-nm laser vaporization compared to transurethral resection of the prostate: results from a prospective three-dimensional ultrasound volumetry study.

PURPOSE: To assess and compare postoperative prostate volume changes following 532-nm laser vaporization (LV) and transurethral resection of the prostate (TURP). To investigate whether differences in volume reduction are associated with differences in clinical outcome. METHODS: In this prospective, non-randomized study, 184 consecutive patients undergoing 120 W LV (n = 98) or TURP (n = 86) were included. Transrectal three-dimensional ultrasound and planimetric volumetry of the prostate were performed preoperatively, after catheter removal, 6 weeks, 6 and 12 months. Additionally, clinical outcome parameters were recorded. Mann-Whitney U test and analysis of covariance were utilized for statistical analysis. RESULTS: Postoperatively, a significant prostate volume reduction was detectable in both groups. However, the relative volume reduction was lower following LV (18.4 vs. 34.7 %, p < 0.001). After 6 weeks, prostate volumes continued to decrease in both groups, yet differences between the groups were less pronounced. Nonetheless, the relative volume reduction remained significantly lower following LV (12 months 43.3 vs. 50.3 %, p < 0.001). All clinical outcome parameters improved significantly in both groups. However, the maximum flow rate (Q max) and prostate-specific antigen (PSA) reduction were significantly lower following LV. Subgroup analyses revealed significant differences only if the initial prostate volume was >40 ml. Re-operations were necessary in three patients following LV. CONCLUSIONS: The modest but significantly lower volume reduction following LV was associated with a lower PSA reduction, a lower Q max and more re-operations. Given the lack of long-term results after LV, our results are helpful for preoperative patient counseling. Patients with large prostates and no clear indication for the laser might not benefit from the procedure.

Pure bipolar plasma vaporization of the prostate: the Zürich experience.

INTRODUCTION AND OBJECTIVES: Bipolar plasma vaporization (BPV) has been introduced as an alternative to transurethral resection of the prostate (TURP). Promising short-term results, but inferior mid-term results compared to TURP have been reported following first-generation bipolar electrovaporization. Outcome data following second-generation BPV are still scarce. The aim of this investigation was to evaluate the intra- and postoperative outcomes of contemporary BPV in a center with long-standing expertise on laser vaporization of the prostate. METHODS: A consecutive series of 83 patients undergoing BPV in a tertiary referral center was prospectively evaluated. The investigated outcome parameters included the maximum flow rate (Qmax), postvoid residual volume, International Prostate Symptom Score (IPSS)/quality of life (Qol), and prostate-specific antigen (PSA) tests. Follow-up investigations took place after 6 weeks, 6 months, and 12 months. The Wilcoxon signed-rank test was used to compare pre- and post-treatment parameters. RESULTS: The median (range) preoperative prostate volume was 41 mL (17-111 mL). The preoperative IPSS, Qol, Qmax, and residual volume were 16 (2-35), 4 (0-6), 10.1 mL/s (3-29.3 mL/s), and 87 mL (0-1000 mL), respectively. One third of the patients were undergoing platelet aggregation inhibition (PAI). No intraoperative complications occurred. Postoperatively, 13 patients (15.7%) had to be recatheterized. Three patients (3.6%) had clot retention and 28 patients (34%) reported any grade of dysuria. After 6 weeks, all outcome parameters improved significantly and remained improved over the 12-month observation period [IPSS: 3 (0-2); Qol: 1 (0-4); Qmax: 17.2 mL/s (3.2-56 mL/s); residual volume 11 mL (0-190 mL)]. The PSA reduction was 60% at study conclusion. Three patients (3.6%) developed a urethral stricture and four patients (4.8%) bladder neck sclerosis. Re-resections were not necessary. CONCLUSIONS: Contemporary BPV is a safe and efficacious treatment option even for patients undergoing PAI. Early urinary retention and temporary dysuria seem to be specific side effects of the treatment. Bleeding complications are rare. Long-term follow-up is needed to confirm these promising short-term results.