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Objective The primary objective of this clinical trial is to investigate the effect of low-intensity pulsed ultrasound (LIPUS) on patients suffering from comorbid erectile dysfunction (ED) and chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS). Methods The clinical trial was conducted in the andrology outpatient treatment room of the Department of Urology, Xiangya Hospital, Central South University from August to November 2022 A total of 60 patients who met the research criteria for comorbid ED combined with CP/CPPS were recruited and randomly assigned to three treatment groups. They were treated with LIPUS (Group A), drug therapy(Group B), and LIPUS combined with drug therapy (Group C), respectively. Each group comprised 20 patients. Statistical analysis was performed on the five-item version of International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the nine-item Patient Health Questionnaire (PHQ-9), the seven-item Generalized Anxiety Disorder Scale (GAD-7), and the incidence of adverse events to comprehensively evaluate the efficacy and safety of LIPUS. Results The positive response rate of ED and CP/CPPS treatment in Group A is 40%(8/20) and 45%(9/20), while those in Group B is 55%(11/20) and 60%(12/20), and those in Group C is 85%(17/20) and 85%(17/20). A notable increase in IIEF-5 scores was observed across the three groups post-treatment (10.45 ± 2.50 vs. 13.65 ± 3.03, P  = 0.008; 11.80 ± 3.21 vs. 16.40 ± 3.20, P  = 0.011; 12.90 ± 3.92 vs. 19.40 ± 2.35, P  = 0.042) with a concomitant significant decrease in NIH-CPSI scores (16.75 ± 4.53 vs. 14.65 ± 4.51, P  = 0.016; 16.35 ± 4.32 vs. 12.20 ± 4.74, P  = 0.007; 16.00 ± 4.40 vs. 8.15 ± 4.28, P  = 0.021). Notably, the most pronounced changes were seen in the group receiving LIPUS combined with tadalafil and doxazosin. Additionally, all groups exhibited marked improvements in anxiety and depression symptoms post-treatment. No adverse events were observed during treatment. Conclusion LIPUS can improve erectile function and CP/CPPS symptoms with good safety, and LIPUS combined with tadalafil and doxazosin is more effective during the treatment. However, its long-term efficacy remains to be seen. Trial Registration Chinese Clinical Trial Registry; approval number: ChiCTR2200063038 ( https://www.chictr.org.cn/ ) on August 29, 2022.

Purpose Acupuncture has been recommended as an effective therapy to improve symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We conducted this secondary analysis to explore the factors that may influence the response of patients with CP/CPPS to acupuncture. Methods This secondary analysis was based on a randomized controlled trial demonstrating the efficacy of acupuncture among patients with CP/CPPS. Responder is defined as a patient with a decrease of  ≥ 6 points in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline at the 32 week. 206 patients who received acupuncture treatment and completed 32-week follow-up were included in this secondary analysis. Descriptive statistics were used to describe the demographic and clinical characteristics of both responders and non-responders in acupuncture group. Logistic regression analysis with bootstrapping was made to identify potential factors that contributed to the effectiveness of acupuncture for treating CP/CPPS. Responders and non-responders were listed as dependent variables. Results In this study, 130 (63.11%) patients were assessed as responders. The results showed that men with non-sedentariness (OR 4.170 [95%CI 1.837 to 9.463; P  = 0.001]), non-smoking habit (OR 2.824 [95%CI 1.453 to 5.487; P  = 0.002]), without comorbidity (OR 8.788 [95%CI 1.912 to 40.295; P  = 0.005]), and severe NIH-CPSI total score (OR 0.227 [95%CI 0.114 to 0.450; P  < 0.0001]) benefited more from acupuncture intervention. Conclusion CP/CPPS patients who are active, non-smokers, without comorbidity, and had severe symptoms may be more likely to respond to acupuncture.

PurposeIn this placebo-controlled trial, we aimed to evaluate the clinical results of using PDE-5 inhibitor, tadalafil 5 mg OD, for management of CP/CPPS.Patients and methods140 patients ≤ 45 years old with moderate/severe CP/CPPS associated with ED (IIEF-5 < 22) were randomly divided and received either tadalafil 5 mg OD (tadalafil-group) or placebo (control-group) for 6 weeks. Post-treatment CPSI scores were compared to baseline and to placebo. Clinically significant responders (≥ 25% reduction from baseline score) were calculated. Tadalafil-induced changes in IIE-5 were evaluated in correlation to that of CPSI scores.ResultsBy the 6th week, 59 and 56 patients were available in both groups respectively. Compared to baseline, tadalafil-group patients showed significant improvement in total, pain, urinary and Qol domains of CPSI (19.1 ± 5.26, 10.42 ± 3.55, 4.2 ± 1.72 and 4.47 ± 1.64 vs. 24.21 ± 5.05, 12.14 ± 3.57, 6.08 ± 1.53 and 6.22 ± 1.76), p < 0.5. When compared to placebo, all 6th week CPSI domains scores, except for pain, were significantly better in tadalafil-group (p < 0.05). Post-treatment pain score didn't significantly differ between both groups (10.42 ± 3.55, vs. 11.71 ± 3.9, p > 0.05). Clinically significant responders were 30 patients (50.8%) in tadalafil-group vs. 3 patients (5.4%) in control. Tadalafil-induced changes in IIEF-5 score had weak but significant correlation to Qol domain (r = − 0.28, p < 0.05).ConclusionTadalafil 5 mg OD can significantly improve all CPSI domains as compared to baseline. Post-treatment CPSI scores, except for pain, were better than placebo. About 50.8% of patients can develop ≥ 25% reduction in their total CPSI scores after treatment. Apart from Qol domain, these changes are not significantly correlated to tadalafil-induced IIEF-5 scores changes.

To evaluate the efficacy and safety of tamsulosin combined with dapoxetine in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that is complicated by premature ejaculation (PE), a total of 251 CP/CPPS patients with PE were recruited from nine hospitals across China and were randomly divided into two groups: one received tamsulosin as a control, and the other received a combination therapy of tamsulosin and dapoxetine. Follow‐up was conducted at four time points, and indicators describing CP/CPPS and PE were compared between the two groups. In all, 223 patients were followed up at least once, and 114 patients completed all of the treatment process. The combination group showed more improvement in the symptoms of both PE and CP/CPPS, including thrust number (50.5 vs. 45), premature ejaculation profile score (11.39 vs. 6.96), intravaginal ejaculation latency time (5.95 min vs. 2.63 min) and the National Institutes of Health Chronic Prostatitis Symptom Index (7.44 vs. 11.81) in comparison with the tamsulosin group. In conclusion, for CP/CPPS patients with PE, tamsulosin combined with dapoxetine provided better therapeutic efficacy in the treatment of not only PE symptoms but also CP/CPPS indicators in comparison with tamsulosin monotherapy.

This study aims to determine the effect of radial extracorporeal shock wave therapy (rESWT) versus drug when treating chronic pelvic pain syndrome (CPPS; type III B chronic prostatitis). The study included 45 participants with CPPS, divided into two groups: Group I comprised 25 participants, who were treated with rESWT (3,000 pulses each; pressure: 1.8–2.0 bar; frequency: 10 Hz) once a week; Group II consisted of 20 participants who received a combination of an α-blocker and an anti-inflammatory agent. Participants were treated for 8 weeks. The assessments were done before treatment, after the fourth and eighth rESWT, and 3 months after the end of treatment by Visual Analogue Scale (VAS) for pain, National Institutes of Health-developed Chronic Prostatitis Symptom Index (NIH-CPSI), International Prostate Symptom Score (IPSS), quality of life (QoL), and International Index of Erectile Function-5 (IIEF-5). Both groups of participants showed statistically significant improvement in all the assessments (p < .001) after the treatment, with significantly better results in Group I in NIH-CPSI (p < .001). The recurrence rate of symptoms in Group I at 3 months after end of treatment was much lower than that in Group II (4% vs. 50%, p < .001). This prospectively nonrandomized, control study revealed perineal rESWT as a new therapy option for CPPS with statistically significant effects in comparison to drugs at least for 3 months after cessation of treatment.

This study was undertaken to evaluate the influence of treatment with rifaximin followed by the probiotic VSL#3 versus no treatment on the progression of chronic prostatitis toward chronic microbial prostate-vesiculitis (PV) or prostate-vesiculo-epididymitis (PVE). A total of 106 selected infertile male patients with bacteriologically cured chronic bacterial prostatitis (CBP) and irritable bowel syndrome (IBS) were randomly prescribed rifaximin (200 mg, 2 tablets bid, for 7 days monthly for 12 months) and probiotic containing multiple strains VSL#3 (450 × 10(9) FU per day) or no treatment. Ninety-five of them (89.6%) complied with the therapeutic plan and were included in this study. Group A = \"6Tx/6-\": treatment for the initial 6 and no treatment for the following 6 months (n = 26); Group B = \"12Tx\": 12 months of treatment (n = 22); Group C = \"6-/6Tx\": no treatment for the initial 6 months and treatment in the last 6 months (n = 23); Group D = \"12-\": no treatment (n = 24). The patients of Groups A = \"6Tx/6-\" and B = \"12Tx\" had the highest frequency of chronic prostatitis (88.5% and 86.4%, respectively). In contrast, group \"12-\": patients had the lowest frequency of prostatitis (33.4%). The progression of prostatitis into PV in groups \"6Tx/6-\" (15.5%) and \"6-/6Tx\" (13.6%) was lower than that found in the patients of group \"12-\" (45.8%). Finally, no patient of groups \"6Tx/6-\" and \"6-/6Tx\" had PVE, whereas it was diagnosed in 20.8% of group \"12-\" patients. Long-term treatment with rifaximin and the probiotic VSL#3 is effective in lowering the progression of prostatitis into more complicated forms of male accessory gland infections in infertile patients with bacteriologically cured CBP plus IBS.

Background Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS. Methods The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks. Results In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat ( n  = 50) or the pollen extract ( n  = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study. Conclusion Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract. Trial registration The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan ( UMIN000019618 ); registration date: 3 November 2015.

Background: The potential benefits of a therapeutic regimen for chronic pelvic pain syndrome (CPPS) based on the adherence to some specific rules concerning diet, sexual habits and lifestyle have never been investigated. Methods: A review of literature was executed to prepare a vademecum of 13 rules relating to diet, sexual habits and lifestyle that patients had to adhere to in order to treat CPPS. Patients affected by CPPS were enrolled and assigned to two equal groups that were both treated with 100 mg of nimesulide for 1 week. Group two patients were instructed to adhere to the vademecum rules, whereas patients in Group one received instructions to make no changes in their lifestyles. The NIH-Chronic Prostatitis Symptom Index was administered at baseline and after 3 months. The main outcome measure was the change in the mean total NIH-Chronic Prostatitis Symptom Index scores between the two groups from baseline to after treatment. Statistical methods for two-group comparisons were used. Results: Overall,100 patients were recruited. Thirty-nine out of fifty patients (78%) belonging to Group two adhered to the vademecum rules. In Group one, the total NIH-Chronic Prostatitis Symptom Index score was 21.9 at baseline and 17.6 post-treatment, whereas in Group two these scores were 22.1 and 8.1, respectively ( P <0.0001). Conclusions: We detected 13 potentially eliminable risk factors for CPPS on the basis of which we prepared a vademecum of 13 rules to treat this disease that were well tolerated and highly effective in significantly reducing all types of symptoms caused by CPPS.

Inflammation is inherent in prostatic diseases and it is now accepted that it may facilitate cellular proliferation in both benign and malignant conditions. The strong relationship between prostatic inflammation and pathogenesis of benign prostatic hyperplasia (BPH) is supported by epidemiologic, histopathologic and molecular evidence. Contrariwise, the role of inflammation in prostate carcinogenesis is still controversial, although current data indicate that the inflammatory microenvironment can regulate prostate cancer (PCa) growth and progression. Knowledge of the complex molecular landscape associated with chronic inflammation in the context of PCa may lead to the introduction and optimization of novel targeted therapies. In this perspective, evaluation of the inflammatory component in prostate specimens could be included in routine pathology reports.

Background Acupuncture is an attractive treatment option for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that has proved refractory to conventional medical treatments. Unfortunately, it is difficult to determine the benefit of acupuncture because few studies have employed controls or had physiological outcome measures. Objective To determine the feasibility of a sham, or minimally invasive, acupuncture as a control for studies evaluating the efficacy of acupuncture treatment for chronic pelvic pain. Methods Participants were recruited from a double-blind randomised trial comparing acupuncture with a sham procedure for patients with CP/CPPS. Acupuncture or sham procedures were performed over a 10-week period. Sham acupuncture involved placement of short needles at sites 0.5 cm away from true acupuncture points (CV1, CV4, SP6 and SP9). Participants were asked to determine their procedure allocation at the end of treatment. A total of 35participants also agreed to have blood analyses for cortisol, β-endorphin and leucine-enkephalin. Results Thirty-five (78%) of the 45 participants randomised to the sham treatment thought they had received acupuncture compared with 27 (61%) of the 44 participants randomised to acupuncture (p=0.11). Biochemical data showed no differences between the groups immediately after treatment. Thirty-two (73%) of 44 acupuncture participants met the predefined clinical response criterion compared with 21 (47%) of 45 sham acupuncture participants (p=0.017, relative risk 1.81, 95% CI 1.3 to 3.1). At the end of the study, β-endorphin and leucine-enkephalin levels were both higher in the acupuncture group (p<0.01). Conclusions Minimally penetrating acupuncture was found to be a valid sham control and may prove useful for evaluating the efficacy of acupuncture for other conditions. (ClinicalTrials.gov number, NCT00260637)