Efficacy of the new P100 extracorporeal shock wave therapy device in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome: a sham treatment controlled, prospective clinical trial.

Use of the UPOINT Chronic Prostatitis/Chronic Pelvic Pain Syndrome Classification in European Patient Cohorts: Sexual Function Domain Improves Correlations

Introduction. Despite the progress in diagnostic and therapeutic approaches based on a growing understanding of the etiopathogenesis of chronic prostatitis/chronic pelvic pain syndrome, there is no internationally consensus-approved single drug therapy with proven efficacy against this syndrome, which leads to the adoption of multimodal approaches to the treatment of chronic prostatitis/chronic pelvic pain syndrome. There are also many contradictory results regarding the effect of extracorporeal shock wave therapy on chronic prostatitis/chronic pelvic pain syndrome, especially due to the lack of long-term follow-up. Objective. To comprehensively evaluate the treatment of chronic prostatitis/chronic pelvic pain syndrome using extracorporeal shock wave therapy. Materials and Methods. The treatment results of 53 patients with chronic prostatitis/chronic pelvic pain syndrome were studied. The patients' age ranged from 20 to 38 years, with an average of 32.43±5.81 years. The duration of the disease was 2.9±0.8 years. Patients received combination therapy consisting of an α₁adrenoblocker, a nonsteroidal anti-inflammatory drug (NSAID) for analgesia, and extracorporeal shock wave therapy (ESWT) sessions. Results. In general, there was a significant decrease in the severity of clinical symptoms according to the NIH-CPSI scale by the end of the course and a further decrease after treatment. At the same time, there was an improvement in the patients’ quality of life (based on the QoL score). As part of the comprehensive management, patients showed a decrease in the number of leukocytes in the prostate secretion. Regarding the number of lecithin grains, the index reached 1.79 ± 0.19 after 1–1.5 months of treatment, indicating continued positive dynamics in the composition of prostatic secretion. Analysis of uroflowmetry dynamics revealed a statistically significant improvement in all parameters during the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with extracorporeal shock wave therapy (ESWT). Key findings on the prostate response to ESWT were obtained through ultrasound examination, which included measurement of organ blood flow parameters. An increase in prostate volume was observed, ranging from 2 to 6 cm³ (mean: 3.54 ± 0.52 cm³), compared to a baseline average volume of 17.36 ± 1.49 cm³, representing an average increase of approximately 20.2%. At the follow-up examination conducted two weeks after completion of therapy, the prostate gland volume returned to baseline levels, indicating the reversibility of the transient volume increase associated with treatment. Conclusions. 1. During treatment, a significant reduction in the severity of clinical symptoms was observed, as measured by the NIH-CPSI scale. Scores decreased from 24.71 ± 1.37 before treatment to 10.92 ± 0.74 at the end of therapy, and further declined to 9.42 ± 1.03 one month post-treatment. This improvement was accompanied by a notable enhancement in quality of life (QoL), with scores improving from 4.93 ± 0.57 to 3.84 ± 0.58. The baseline prostate volume was 17.36 ± 1.49 cm³. After 12–14 days of therapy, a temporary increase to 20.87 ± 1.93 cm³ was noted. However, by 1–1.5 months post-treatment, the volume returned to 16.97 ± 1.74 cm³, approximating the baseline value. Prostatic blood flow significantly increased over the course of treatment. Pre-treatment levels were 0.031 ± 0.005 L/min, rising to 0.047 ± 0.009 L/min after therapy (p < 0.05), and further increasing to 0.058 ± 0.003 L/min one month post-treatment (p < 0.05 compared to baseline). Based on the findings, the inclusion of extracorporeal shock wave therapy (ESWT) in the comprehensive management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is both justified and clinically effective.

6-Day Intensive Treatment Protocol for Refractory Chronic Prostatitis/Chronic Pelvic Pain Syndrome Using Myofascial Release and Paradoxical Relaxation Training

Aim This study aims to evaluate the long-term effectiveness of Li-ESWT in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) patients and to compare the effect of treatment protocol differences on success. Method Between December 2019 and January 2021, the data of male patients over the age of 18 who applied to the urology outpatient clinic with CP/CPPS symptoms were retrospectively analyzed. International Prostate Symptom Index (IPSS) and International Index of Erectile Function—Erectile Function (IIEF-EF) questionnaires were filled in for the evaluation of erectile function. All patients received treatment with the Medispect Bold Li-ESWT. The treatment responses of the patients who received a total of 6 sessions from one session per week and 12 sessions from two sessions per week were compared. Results A total of 129 patients were included in the study. Significant improvements were observed in the NIH-CPSI, IPSS, and IIEF-EF scores at the third month follow-ups of the patients after EWST (p < 0.001 for each). Improvements in scores were also found to be significant in NIH-CPSI, IPSS, and IIEF-EF at the 12th month evaluation. When the patients were evaluated according to the number of Li-ESWT sessions they received, the IPSS score average of the patient group who received 12 sessions of Li-ESWT was found to be lower than the patients who received 6 sessions of Li-ESWT (5.67 ± 2, 30 vs 4.51 ± 2.21; p = 0.005). There was no significant difference in the IIEF-EF and IPSS scores in the 12th month evaluations of the patients, but the mean NIH-CPSI score was found to be higher in the group that received 12 sessions of Li-ESWT (p = 0.003). Conclusion Li-ESWT in the treatment of CP/CPPS patients shows positive improvements in urinary symptoms, erectile function, and quality of life in patients unresponsive to other medical treatments. The increase in the number of sessions does not seem to influence the symptoms of the patients.

The aim of this study was to evaluate the efficacy and safety of extracorporeal shockwave therapy (ESWT) and acupuncture therapy for patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).We searched electronic databases including PubMed, Cochrane Library, Embase and web of science from its inception to June 1, 2021. The randomized controlled trials (RCTs) that compared ESWT and acupuncture in the management of CP/CPPS were identified. A network meta-analysis was conducted with the software of STATA 14.0.Nine RCTs with 525 patients were enrolled in our analysis. The results revealed that both ESWT and acupuncture were significantly better than the sham procedure in the outcomes of total score of NIH-CPSI, pain subscore, urinary symptoms subscore, QoL subscore, IPSS score, the IIEF score and response rates (p < .05). Both ESWT and acupuncture were well-tolerated and had no obviously increased adverse events. Compared with acupuncture, ESWT was associated with better short term (<4w) and mid-term (8-12 w) efficacy of total score, pain subscore, urinary symptoms subscore, and QoL subscore of NIH-CPSI, IPSS score, IIEF score, and response rate. However, ESWT did not present better long-term (<24 w) outcomes than acupuncture in total score, pain subscore, urinary symptoms subscore, and QoL subscore of NIH-CPSI.Both ESWT and acupuncture were effective and well-tolerated in the management of CP/CPPS. ESWT seemed to have better short (<4 w) and mid-term (8-12 w) efficacy but similar long-term (>24 w) efficacy than acupuncture.

BackgroundChronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, combined therapy with extracorporeal shockwave therapy and myofascial release therapy will likely have significant advantages in treating CP/CPPS. We, therefore, present a protocol for conducting a well-designed randomized controlled trial to compare the efficacy and safety of each therapy.MethodsThe proposed study will be a three-group randomized control trial (RCT) design that includes 150 participants from Zhongda Hospital Affiliated to Southeast University, with equal allocation of participants to the three intervention groups. The study duration will be 8 weeks, which includes a 4-week treatment period and a 4-week follow-up period. The primary outcome will be the changes in surface electromyography (sEMG) assessment and National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcomes will include the changes in three-dimensional quantification, shear wave elastography (SWE), and sympathetic skin response (SSR) testing. Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and the 4th week after the end of the 8th intervention (T3).DiscussionThis trial will compare the differences in efficacy between single extracorporeal shockwave therapy, single myofascial release therapy, and combined therapy to select the most appropriate treatment option for patients with CP/CPPS. The possible pathogenesis of CP/CPPS would also be analyzed by comparing the intercorrelation between each objective and subjective measurement (NIH-CPSI score, sEMG, SWE, SSR).Trial registrationThe name of the registry: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome.Registration number: NCT05659199. Date of registration: December 2022.

Influence of Environmental Factors on Prevalence, Symptoms, and Pathologic Process of Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Northwest China

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common male urological disease characterized by chronic pelvic pain. Extracorporeal shock wave therapy (ESWT) has been used to treat patients with CP/CPPS, but the parameters used by ESWT are not uniformly determined. Herein, this study aims to assess the effects of ESWT with different energy flux densities on pelvic pain in CP/CPPS rats and to explore the mechanisms. A rat model of CP/CPPS was induced by intraprostatic injection of 1% carrageenan. ESWT with different energy flux densities (0.09, 0.20, 0.30, 0.40mJ/mm2) was applied in the pelvic region of CP/CPPS rats once a week for 4weeks. The results showed that compared with the other energy flux densities (0.09, 0.30, and 0.40mJ/mm2), ESWT with 0.20mJ/mm2 exhibited a more powerful effect in alleviating pelvic pain and prostate damage. The therapeutic effect is associated with the reduction of the number of total and degranulated mast cells. Collectively, ESWT with 0.20mJ/mm2 achieved the optimal therapeutic effect in alleviating pelvic pain in CP/CPPS rats.

Purpose: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), affecting over 90% of patients with symptomatic prostatitis, remains a therapeutic challenge and adversely affects patients’ quality of life (QoL). This study probed for likely beneficial effects of ESWT, evaluating its extent and durability. Patients and methods: Standardized indices, namely the pain, urinary, and QoL domains and total score of NIH-CPSI, IIEF-5, EHS, IPSS, and AUA QoL_US were employed in this study of patients with CP/CPPS who had been refractory to other prior treatments (n = 215; age range: 32–82 years; median age: 57.5 ± 12.4 years; modal age: 41 years). Results: For CP symptoms, the mean pre-ESWT NIH-CPSI total score of 27.1 ± 6.8 decreased by 31.3–53.6% over 12 months after ESWT. The mean pre-ESWT NIH-CPSI pain (12.5 ± 3.3), urinary (4.98 ± 2.7), and QoL (9.62 ± 2.1) domain scores improved by 2.3-fold, 2.2-fold, and 2.0-fold, respectively, by month 12 post-ESWT. Compared with the baseline IPSS of 13.9 ± 8.41, we recorded 27.1–50.9% amelioration of urinary symptoms during the 12 months post-ESWT. For erectile function, compared to pre-ESWT values, the IIEF-5 also improved by ~1.3-fold by month 12 after ESWT. This was corroborated by EHS of 3.11 ± 0.99, 3.37 ± 0.65, 3.42 ± 0.58, 3.75 ± 0.45, and 3.32 ± 0.85 at baseline, 1, 2, 6, and 12 months post-ESWT. Compared to the mean pre-ESWT QoL score (4.29 ± 1.54), the mean QoL values were 3.26 ± 1.93, 3.45 ± 2.34, 3.25 ± 1.69, and 2.6 ± 1.56 for months 1, 2, 6, and 12 after ESWT, respectively. Conclusions: This study shows ESWT, an outpatient and easy-to-perform, minimally invasive procedure, effectively alleviates pain, improves erectile function, and ameliorates quality of life in patients with refractory CP/CPPS.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in which the two main clinical features are pelvic pain and lower urinary tract symptoms. There are currently many approaches for its management, using both pharmacological and non-pharmacological interventions. The National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score is a validated measure commonly used to measure CP/CPPS symptoms. To assess the effects of non-pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017. We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available non-pharmacological interventions. Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence (QoE) according to the GRADE methods. We included 38 unique studies with 3290 men with CP/CPPS across 23 comparisons.1. Acupuncture: (three studies, 204 participants) based on short-term follow-up, acupuncture probably leads to clinically meaningful reduction in prostatitis symptoms compared with sham procedure (mean difference (MD) in total NIH-CPSI score -5.79, 95% confidence interval (CI) -7.32 to -4.26, high QoE). Acupuncture may result in little to no difference in adverse events (low QoE). Acupuncture may not reduce sexual dysfunction when compared with sham procedure (MD in the International Index of Erectile Function (IIEF) Scale -0.50, 95% CI -3.46 to 2.46, low QoE). Acupuncture may also lead to a clinically meaningful reduction in prostatitis symptoms compared with standard medical therapy (MD -6.05, 95% CI -7.87 to -4.24, two studies, 78 participants, low QoE). We found no information regarding quality of life, depression or anxiety.2. Lifestyle modifications: (one study, 100 participants) based on short-term follow-up, lifestyle modifications may be associated with a reduction in prostatitis symptoms compared with control (risk ratio (RR) for improvement in NIH-CPSI scores 3.90, 95% CI 2.20 to 6.92, very low QoE). We found no information regarding adverse events, sexual dysfunction, quality of life, depression or anxiety.3. Physical activity: (one study, 85 participants) based on short-term follow-up, a physical activity programme may cause a small reduction in prostatitis symptoms compared with control (NIH-CPSI score MD -2.50, 95% CI -4.69 to -0.31, low QoE). This programme may not reduce anxiety or depression (low QoE). We found no information regarding adverse events, sexual dysfunction or quality of life.4. Prostatic massage: (two studies, 115 participants) based on short-term follow-up, we are uncertain whether the prostatic massage reduces or increases prostatitis symptoms compared with control (very low QoE). We found no information regarding adverse events, sexual dysfunction, quality of life, depression or anxiety.5. Extracorporeal shockwave therapy: (three studies, 157 participants) based on short-term follow-up, extracorporeal shockwave therapy reduces prostatitis symptoms compared with control (NIH-CPSI score MD -6.18, 95% CI -7.46 to -4.89, high QoE). These results may not be sustained at medium-term follow-up (low QoE). This treatment may not be associated with a greater incidence of adverse events (low QoE). This treatment probably improves sexual dysfunction (MD in the IIEF Scale MD 3.34, 95% CI 2.68 to 4.00, one study, 60 participants, moderate QoE). We found no information regarding quality of life, depression or anxiety.6. Transrectal thermotherapy compared to medical therapy: (two studies, 237 participants) based on short-term follow-up, transrectal thermotherapy alone or in combination with medical therapy may decrease prostatitis symptoms slightly when compared with medical therapy alone (NIH-CPSI score MD -2.50, 95% CI -3.82 to -1.18, low QoE). One included study reported that participants may experience transient adverse events. We found no information regarding sexual dysfunction, quality of life, depression or anxiety.7. Other interventions: there is uncertainty about the effects of most of the other interventions included in this review. We found no information regarding psychological support or prostatic surgery. Based on the findings of moderate quality evidence, this review found that some non-pharmacological interventions such as acupuncture and extracorporeal shockwave therapy are likely to result in a decrease in prostatitis symptoms and may not be associated with a greater incidence of adverse event. The QoE for most other comparisons was predominantly low. Future clinical trials should include a full report of their methods including adequate masking, consistent assessment of all patient-important outcomes including potential treatment-related adverse events and appropriate sample sizes.

Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally immunostimulating agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III. Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo. Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p = 0.59; PPS: p = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa. This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated. 2007-004609-85.

To evaluate the efficacy of shockwave therapy, acupuncture, hyperthermia, biofeedback therapy, electrical nerve stimulation, magnetotherapy and ultrasound therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS), and to provide evidence-based support for clinical decision-making. Two researchers independently searched PubMed, Web of Science, Embase, Cochrane Library, CNKI, Wanfang, VIP and Chinese Biomedical Literature databases for randomized controlled trials(RCTs) on the effects of different interventions on CP/CPPS from the establishment of the databases to August 2024. We evaluated the quality of the included literature and extracted the relevant data according to the Cochrane Handbook for Systematic Reviews of Interventions, followed by network meta-analysis using Revman 5.3, R 4.33 and Stata17 software. A total of 25 RCTs involving 1 794 cases were included. The results of network meta-analysis showed that electrical nerve stimulation, shockwave therapy, biofeedback therapy, magnetotherapy, ultrasound therapy and acupuncture were significantly superior to conventional medication and placebo in the total NIH-CPSI scores(P< 0.05), and so were electrical nerve stimulation and shockwave therapy to acupuncture and hyperthermia(P< 0.05), magnetic therapy to hyperthermia, and ultrasound therapy to placebo(P< 0.05). Shockwave therapy, biofeedback therapy, electrical nerve stimulation, magnetotherapy and ultrasound therapy achieved remarkably better clinical efficacy than conventional medication and placebo in the treatment of CP/CPPS, and so did shockwave therapy than electrical nerve stimulation, hyperthermia, ultrasonic therapy, magnetotherapy and acupuncture. For the treatment of CP/CPPS, electrical nerve stimulation is advantageous over the other interventions in improving total NIH-CPSI scores, and shockwave therapy is advantageous in relieving pain symptoms and clinical efficacy. This conclusion, however, needs to be further verified by more high-quality clinical studies.

BackgroundRecent data showed that a six-domain UPOINT is a flexible and responsive new classification system that has the clinical applicability in CP/CPPS. However, the utility of UPOINT algorithm in men in China with CP/CPPS has not been comprehensively studied. For international validation and adoption, we evaluated this clinical phenotype system for a large cohort of Chinese CP/CPPS patients and correlated it with patient symptoms and erectile dysfunction (ED). We also investigated the addition of an ED domain in regard to symptom correlation.MethodsA total of 389 Chinese males with CP/CPPS were prospectively collected and classified in each domain of the UPOINT system. Symptom severity was measured using the NIH-CPSI and IPSS. The erectile function was evaluated using the IIEF-5. Clinically relevant associations were calculated.ResultsThe percentage of patients positive for each domain was 54.0%, 42.1%, 41.9%, 20.8%, 26.7%, and 40.4% for the Urinary, Psychosocial, Organ-specific, Infection, Neurological/systemic, and Tenderness, respectively. There were significant correlations between the number of positive UPOINT domains and total NIH-CPSI (r = 0.706, p<0.001), IPSS (r = 0.682, p<0.001) and IIEF-5 scores (r = 0.631, P = 0.007) in Chinese cohort. Except for patients age, symptom duration was associated with a significantly greater number of positive domains (r = 0.638, P = 0.005). After adding an ED domain to create a modified UPOINT system, the correlation between the number of phenotypic domains and symptom severity was improved (0.706 to 0.844, p<0.001).ConclusionsThe clinical applicability of using UPOINT phenotyping system has been validated in the Chinese patients with CP/CPPS. In our cohort, the number of positive domains was also correlated with ED symptoms and the significant association between the number of UPOINT domains and NIH-CPSI scores was further refined by adding a domain for ED. Our findings presented here support the utility of using ED as a stand-alone item in the UPOINT domain.

This study aims to evaluate the effect of extracorporeal shock wave therapy (ESWT) on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to explore the mechanism. RWPE-2 cells were randomly divided into three groups: (a) RWPE-2 group (normal control), (b) LPS groups (lipopolysaccharide inducing inflammation) and (c) ESWT groups (LPS induced RWPE-2 treated by ESWT). After ESWT was administered, cells and supernatant were collected for enzyme-linked immunosorbent assay (ELISA) and Western blot analysis. In vivo, Sprague-Dawley rats (n = 30) were randomly divided into three groups: (a) normal control group, (b) prostatitis groups, and (c) ESWT groups. Prostatitis rats were induced by 17 β-estradiol and dihydrotestosterone for 4 weeks. After ESWT, prostates of each group were collected for immunohistochemistry, Western blot analysis, and ELISA. ESWT improved prostatitis by attenuating inflammation (P < .01). ESWT downregulated the expression of cyclooxygenase 2 (COX-2) through inhibiting TLR4-NFκB pathway compared with the LPS group in vitro or prostatitis group in vivo (P < .05). TRAF2 mediates ERK1/2-COX2 pathway. ESWT promotes prostate tissue recovery by stimulating vascular endothelial growth factor expression (P < .01). ESWT could suppress apoptosis in the prostate. ESWT improved CP/CPPS and reduced inflammation by degrading COX-2 in microenvironment through TLR4-NFκB-inhibiting pathway. TRAF2 regulator in ERK1/2-COX-2 inhibition significantly reduced inflammation, thus suggesting ESWT may be a potential and promising treatment for CP/CPPS.

Clustering of UPOINT Domains and Subdomains in Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Contribution to Symptom Severity