Clinical Effects of Oral Supplementation of Gamma-Cyclodextrin Curcumin Complex in Male Patients with Moderate-To-Severe Benign Prostatic Hyperplasia-Related Lower Urinary Tract Symptoms.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTSs) in males. Curcumin exhibits anti-inflammatory and anti-tumor properties which may be effective for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN® (Gamma-cyclodextrin-curcumin Complex-CAVACURMIN®) as single or combination therapy for BPH. METHODS: Men with moderate-severe LUTS/BPH, receiving a 6-month supplementation with QURMIN® alone or in combination with BPH-specific medication were propensity score matched with patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared in the 6-month variation of IPSS, quality of life (IPSS-QoL), Benign Prostatic Hyperplasia Impact Index (BII) and uroflowmetry parameters. Curcumin tolerability was evaluated in terms of discontinuations and adverse effects. RESULTS: The 1:1 propensity score matching resulted in a treatment-naïve (n = 152), an alpha-blocker only (AB) (n = 138) and AB + 5-alpha reductase inhibitors (5-ARIs) (n = 78) subgroup. After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS-storage (-3.9, p < 0.001), IPSS-voiding (-2.0, p = 0.011), IPSS-total (-5.9, p < 0.001), IPSS-QoL (-3.9, p < 0.001), BII (-2.0, p < 0.001), Qmax (+3.1 mL/s, p < 0.001), Qmean (+1.9 mL/s, p = 0.005), post-void residual volume (-7.7 mL, p < 0.001), and PSA (-0.3 ng/mL, p = 0.003), compared to controls. Patients taking ABs and curcumin showed improvement in IPSS-storage (-2.7, p < 0.001), IPSS-voiding (-1.3, p = 0.033), IPSS-total (-3.5, p < 0.001), IPSS-QoL (-1.1, p = 0.004), BII (-1.7, p = 0.006), Qmax (+1.0 mL/s, p = 0.006), and PSA (-0.2 ng/mL, p = 0.01). Patients taking curcumin and AB + 5-ARI showed improvement in IPSS-storage (-1.3, p = 0.007), IPSS-total (-1.6, p = 0.034), IPSS-QoL (-1.1, p < 0.001), and BII (-2.0, p < 0.001). No adverse reactions were reported for curcumin supplementation. CONCLUSION: QURMIN® (CAVACURMIN®) led to significant improvements in symptom burden, uroflow parameters, and QoL, without significant additional side effects, thus proving to be a potential new treatment for BPH, either as a single therapy or in addition to standard treatment.

Impact of Surgery for Benign Prostatic Hyperplasia on Sexual Function: A Systematic Review and Meta-analysis of Erectile Function and Ejaculatory Function.

CONTEXT: Several sexual side effects, including erectile, ejaculatory, and orgasmic dysfunction, were reported with the majority of surgical procedures for benign prostatic obstruction (BPO). OBJECTIVE: To systematically review current evidence regarding the impact of benign prostatic hyperplasia (BPH) surgery on sexual function. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE, Cochrane Library, Embase, Web of Science, and Google Scholar databases was conducted in July 2021. The population, intervention, comparator, and outcome (PICO) model was used to define study eligibility. Studies were Included if they assessed patients with BPO and related lower urinary tract symptoms (P) undergoing BPH surgery (I) with or without a comparison between surgical treatments (C) evaluating the impact on sexual function (O). Retrospective and prospective primary studies were included. A pooled analysis was conducted on studies including the postoperative assessment of International Index of Erectile Function (IIEF)-5, Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD; Function and/or Bother), or retrograde ejaculation (RE) rate (PROSPERO database ID: CRD42020177907). EVIDENCE SYNTHESIS: A total of 151 studies investigating 20 531 patients were included. Forty-eight randomized controlled trials evaluating 5045 individuals were eligible for the meta-analysis. In most studies (122, 80.8%), only erectile and/or ejaculatory function was evaluated. A substantial number of articles (67, 44.4%) also used nonvalidated tools to evaluate erectile and/or ejaculatory function. The pooled analysis showed no statistically significant changes in IIEF-5 score compared with baseline for the transurethral resection of the prostate (TURP; weighted mean difference [WMD] 0.76 pts; 95% confidence interval [CI] -0.1, 1.62; p = 0.08), laser procedure (WMD 0.33 pts; 95% CI -0.1, 0.77; p = 0.13), and minimally invasive treatment (WMD -1.37 pts; 95% CI -3.19, 0.44; p = 0.14) groups. A statistically significantly higher rate of RE was found after TURP (risk ratio [RR] 13.31; 95% CI 8.37, 21.17; p < 0.00001), other electrosurgical procedures (RR 34.77; 95% CI 10.58, 127.82; p < 0.00001), and the entire laser group (RR 17.37; 95% CI 5.93, 50.81; p < 0.00001). No statistically significant increase in RE rate was described after most of the minimally invasive procedures (p > 0.05). The pooled analysis of MSHQ-EjD scores was possible only for prostatic urethral lift, showing no statistically significant difference between baseline and post-treatment MSHQ-EjD Function scores (WMD -0.80 pts; 95% CI -2.41, 0.81; p = 0.33), but postoperative MSHQ-EjD Bother scores were significantly higher (WMD 0.76 pts; 95% CI 0.22, 1.30; p = 0.006). CONCLUSIONS: Erectile function appears to be unaffected by most surgical procedures for BPO. RE is a very common adverse event of BPH surgery, although emerging minimally invasive surgical procedures could be associated with a lower risk. PATIENT SUMMARY: Benign prostatic hyperplasia surgery can have an impact on sexual function, mainly involving ejaculatory function.

Emerging minimally invasive transurethral treatments for benign prostatic hyperplasia: a systematic review with meta-analysis of functional outcomes and description of complications.

INTRODUCTION: Several minimally invasive surgical procedures have been proposed as alternative therapies for benign prostatic hyperplasia (BPH). The present systematic review aimed to describe the functional outcomes and complications of emerging minimally invasive transurethral treatments for BPH. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the Medline and Cochrane Library databases was conducted. No chronological restriction was applied. Retrospective and prospective primary studies were included. A meta-analysis of IPSS, IPSS-QoL, Qmax, and PVR was performed. Data on adverse events were presented narratively. EVIDENCE SYNTHESIS: A total of 18 studies were included. Thirteen papers were eligible for the meta-analysis. iTIND (Medi-Tate Ltd., Or-Akiva, Israel), Rezum (Rezum System, Boston Scientific, Marlborough, MA), and Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) were associated with a significant improvement in IPSS (P<0.001), IPSS-QoL (P<0.001), and Qmax (P<0.001) compared to baseline. A significant reduction of PVR from baseline was found with Rezum (P<0.001) and Aquablation (P<0.001) but not iTIND (P=0.22). A significant difference in IPSS, IPSS-QoL, and Qmax was shown in favor of Aquablation compared to Rezum and iTIND (P<0.001). Rezum and iTIND were mainly associated with mild to moderate adverse effects. Hematuria or bleeding was reported in all studies regarding Aquablation (0.8-26%), the need for transfusion or intervention for bleeding varied between 1.8% and 9%. CONCLUSIONS: Aquablation, Rezum, and iTIND significantly improve urinary functional outcomes compared to baseline; however, Aquablation would seem to lead to better functional results compared to the other procedures. Rezum and iTIND appear to have an excellent safety profile, while Aquablation would seem to expose patients to a non-negligible risk of bleeding.

Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study.

PURPOSE: To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Men with symptomatic BPH (IPSS ≥ 10, Qmax < 12 ml/s, and prostate volume (PV) < 120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5-7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM questionnaires. Post-operative IPSS, QoL, Qmax and PVR were also assessed at 1, 3, and 6 months post-operatively. RESULTS: This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15-80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average post-operative VAS score was 3.24 ± 2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM and MSHQ-EjD questionnaires and significant improvements (p < 0.0001) from baseline levels were recorded in IPSS, QoL and peak flow. CONCLUSION: iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.