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335COMPARISON OF SYMPTOMS IN NEWLY-DIAGNOSED VS CHRONIC-REFRACTORY PATIENTS WITH CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS)

J Curtis Nickel*, Kingston, ONCanada; Richard B Alexander, Baltimore, MD; Rodney U Anderson, Stanford, CA; Richard Berger, Seattle, WA; William L Duncan, Jackson, MS; John N Krieger, Seattle, WA; Mark S Litwin, Los Angeles, CA; Mary McNaughton-Collins, Boston, MA; Michel A Pontari, Philadelphia, PA; Anthony J Schaeffer, Chicago, IL; Daniel A Shoskes, Cleveland, OH; J. Richard Landis, Philadelphia, PA; John W Kusek, Leroy M Nyberg, Bethesda, MD; Shannon Chuai, Philadelphia, PA; The Chronic Prostatitis Collaborative Research Network

INTRODUCTION AND OBJECTIVE: Two distinctly different CP/CPPS cohorts were enrolled into CPCRN randomized clinical trials comparing alfuzosin (diagnosis within the last two years and relatively treatment naive) or pregabalin (more chronic heavily pretreated) with placebo therapy. To gain insight into potential factors associated with CP/CPPS symptom progression, we compared baseline characteristics of these two patient populations.

METHODS: We compared the following baseline parameters (that were collected for both randomized clinical trials): age, duration of symptoms, Chronic Prostatitis Symptom Index (CPSI), McGill Pain Questionnaire, SF-12 Quality of Life, Hospital Anxiety and Depression Scale (HADS), and Sexual Health Inventory for Men (SHIM).

RESULTS: Compared to the 272 patients in the alfuzosin trial the 321 patients in the pregabalin trial had longer symptom duration the (mean 10.2 vs, 1.9 years; p<0.001), were older (47.1 vs. 40.1 years p<0.0001), reported higher CPSI total scores (26.1 vs 24.4; p<0.0004), higher CPSI pain sub-score- (12.4 vs. 11.3; p<0.0001), higher CPSI quality of life sub-score (8.9 vs. 4.6; p<0.0001), poorer SF-12 mental component quality of life (42.1 vs. 44.5; p=0.0092) and more significant anxiety and depression (HADS scores (14.6 vs. 12.8; p=0.0031). There were no differences between cohorts in CPSI urinary sub-scores (4.8 vs. 4.7; p=0.30), SF-12 physical component quality of life (44.6 vs. 45.6; p=0.35) or sexual functioning (SHIM scores 17.1 vs 17.2; p=0.67).

CONCLUSIONS: Duration of symptoms in CP/CPPS may be associated with cognitive progression but not physical progression. Symptom duration is negatively associated with pain, quality of life (particularly mental QoL), anxiety and depression. The duration of symptoms is not associated with urinary, physical and sexual functioning. Early identification and therapy may prevent this apparent cognitive progression associated with symptom duration.

Source of Funding: NIH/NIDDK

336EFFECT OF THE COMBINATION TREATMENT OF URO-DRTM AND MEDICAL THERAPY FOR CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME: A PROSPECTIVE STUDY.

Tag Keun Yoo, Kyung Tae Moon*, Seung Wook Lee, Seoul, Republic of Korea; Hong Sup Kim, Hong Chung, Chungju, Republic of Korea; Jong Yun Kim, Gangneung, Republic of Korea

INTRODUCTION AND OBJECTIVE: Chronic prostatitis/Chronic pelvic pain syndrome (CP/CPPS) is of considerable interest in clinical urology. It is a prevalent and multifactorial condition. URO-DrTM(Somang Medical, Gangneung, Korea) is a portable transrectal thermal therapeutic device for CP/CPPS. We analyzed the outcomes of URO-DrTM combining with medical therapy in patients of CP/CPPS.

METHODS: 120 patients with the major complaint of pelvic pain at least 3 months in duration were enrolled. National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was recorded at Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The patients were randomly divided into three group by medical therapy (antimicrobials+nonsteroidal anti-inflammatory drugs) group (Group I), URO-DrTM therapy group (Group II), Combination of medical therapy and URO-DrTM therapy group (Group III). EPS, Semen analysis, Patient satisfaction questionnaire were completed to assess the changes in prostatic inflammation and to evaluate patient

satisfaction of the therapy. Patient satisfaction questionnaire was consisted of five scales (very dissatisfaction- 1 point, dissatisfaction- 2 point, normal- 3 point, satisfaction- 4 point, and very satisfaction- 5 point).

RESULTS: Group I vs. Group II and Group II vs. Group III were not significantly different from NIH-CPSI, but Group I and Group III were significantly different at pain score and total score of NIH-CPSI (Table1). Group III was significantly improved in Patient satisfaction score compared to Group I (3.79±0.69 Vs. 3.31±0.89, p=0.021).

CONCLUSIONS: Combination therapy of URO-DrTM with medical treatment appeared more effective for treating patients with chronic prostatitis/chronic pelvic pain syndrome than just administering medical drugs or URO-Dr TM monotherapy.

Table 1. Change in NIH-CPSI score before therapy and at last followup.

NIH-CPSIGroup I(N=40) Group II(N=40) Group III(N=40)

p-valueBaseline 12weeks Baseline 12weeks Baseline 12weeks

Pain 10.49±3.66 7.03±4.30 11.16±3.55 7.14±3.59 11.81±3.33 6.13±4.22 0.008

Urination 5.87±2.79 4.18±3.11 5.67±3.01 3.59±2.63 4.51±3.17 2.42±2.16 0.514

QoL 8.87±2.08 6.55±2.69 8.38±2.73 5.68±2.19 8.08±2.31 5.81±2.75 0.164

Total 25.18±5.12 17.92±8.30 25.26±7.15 16.37±6.49 24.59±6.02 13.97±7.39 0.027

Source of Funding: None

337A PROSPECTIVE, RANDOMIZED, PLACEBO CONTROLLED STUDY OF RADIOFREQUENCY THERAPY FOR THE TREATMENT OF CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME

Mi Mi Oh*, Ansansi, Republic of Korea; Myeong Heon Jin, Du Geon Moon, Sang Gan Nam, Seoul, Republic of Korea; Jae Hyun Bae, Hong Seok Park, Ansansi, Republic of Korea

INTRODUCTION AND OBJECTIVE: Male chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a condition of uncertain etiology and treatment is often unsatisfactory. There is evidence that the symptom complex may result from pelvic floor muscular dysfunction and/or neural hypersensitivity/inflammation. We evaluated that the application of radiofrequency therapy may have a therapeutic effect on chronic prostatitis/chronic pelvic pain syndrome.

METHODS: Thirty men with chronic prostatitis/chronic pelvic pain syndrome CPPS (inflammatory or non-inflammatory) for 6 months, and who had failed to improve with standard antibiotic therapy, were prospectively randomized to receive radio-frequency or placebo therapy. Radiofrequency therapy consisted of 30 minutes of pelvic floor stimulation at a frequency of 0.5MHz, twice weekly for 4 weeks. Patients were evaluated at baseline, 1 month after treatment using validated NIH-chronic prostatitis symptom index (NIH-CPSI) and pelvic pain symptom survey (PPSS).

RESULTS: A total of 30 men with a mean age of 46.3 years (range 23 to 72) were analyzed. Of the 30 men 20 were randomized to the active treatment group and 10 were randomized to the placebo treatment group. Mean symptom scores decreased significantly in the actively treated group at 1 months (p<0.05), unlike the placebo group, which showed no significant change (p>0.05). Subanalysis of those receiving active treatment showed that the greatest improvement was in pain related symptoms.

CONCLUSIONS: The novel use of pelvic floor radiofrequency therapy may be a promising new noninvasive option for chronic prostatitis/CPPS in men.

Source of Funding: None

338EXTRACORPOREAL SHOCK WAVE TREATMENT FOR NON-INFLAMMATORY CHRONIC PELVIC PAIN SYNDROME: A PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED STUDY

Xiaoyong Zeng*, Zhangqun Ye, Weimin Yang, Zhiqiang Chen, Guanghui Du, Wuhan, China

INTRODUCTION AND OBJECTIVE: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a clinical syndrome characterized by pain in the perineum, pelvis, suprapubic area, or external genitalia and variable degrees of voiding and ejaculatory disturbance .Extracorporeal

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shock wave therapy (ESWT) has long been used successfully in lithotripsy for the destruction of urinary calculi as a standard urological procedure. The analgesic side effect of ESWT was an interesting phenomenon with an unclear mechanism discovered by chance in the applications for urolithiasis regardless of high or low- dose energy.

This study was designed to evaluate primarily the feasibility and efficacy of ESWT in non-inflammatory(IIIB) CP/CPPS.

METHODS: Men diagnosed with IIIB CP/CPPS were randomized to either ESWT (group 1, n=40) or control (group 2, n=20). Group 1 received 20,000 impulses of shock wave in 10 sessions during 2 weeks, whereas group2 received sham operation under the same condition as the treatment group. The total scores and sub-domain scores (pain, urination and quality of life) of National Institutes of Health (NIH)-Chronic Prostatitis Symptom Index (CPSI) in both groups were accessed in baseline, post-treatment and after 4-week follow-up.

RESULTS: Two men of each group were dropped out. The total CPSI score was decreased significantly from baseline 29.6±7.7 to post-treatment 21.8±1.9(P<0.01) in group 1, and from 28.4±5.2 to 25.4±5.8(P<0.05) in group 2; As for the sub-domain scores, both pain score and quality of life score were decreased significantly compared to baseline, however the urination was not. The total score and pain score continued a lower lever after a 4-week follow-up in group 1, but restored in group 2. The perceptible improvement (>6 points drop in total CPSI) and clinically significant improvement (>12 points, drop in total CPSI) were also accessed. At both post-treatment and after the 4-week follow-up, group 1 had significantly more perceptible and clinically significant improvements than group 2. Throughout the whole study, there was no any adverse event or side effect.

CONCLUSIONS: These findings suggest the potential therapeutic role of ESWT in the treatment of CP/CPPS. Further studies are warranted to ascertain the mechanism and reproducibility of these effects in a multicentre, larger sample size and with longer term follow-up trial.

Source of Funding: None

339MEMANTINE IN THE ALLEVIATION OF SYMPTOMS OF CHRONIC PELVIC PAIN SYNDROME: A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Jordan D Dimitrakov*, Boston, MA; Jean Chitalov, Ivan Dechev, Plovdiv, Bulgaria

INTRODUCTION AND OBJECTIVE: The etiology and underlying pathogenetic mechanisms of chronic pelvic pain syndrome (CPPS) remain elusive. The hallmark of the syndrome is chronic pelvic pain in the absence of identifiable underlying pathology. Recently, CPPS has been conceptualized as a central pain syndrome and N-methyl-D-aspartate (NMDA)-receptor mechanisms have been implicated in the generation of symptoms of CPPS. The objective of this study was to evaluate the efficacy and safety of memantine, a noncompetitive N-methyl-D-aspartate (NMDA)-receptor blocker in the alleviation of CPPS symptoms.

METHODS: 170 men with CPPS were randomly assigned to receive either memantine 20 mg/day or placebo for 1 year. CPPS was diagnosed in accordance with the CPCRN criteria. All patients provided written informed consent and the study was approved by the insitutional review board. The primary outcome was alleviation of pain at 6 months based on the NIH-CPSI pain domain scale. Secondary outcomes were patient-reported improvement in GRA, voiding and quality of life scales of the NIH-CPSI.

RESULTS: The study is ongoing and 1-year results will be presented at the AUA meeting. At 6 months, patients in the memantine group reported significant improvement in pain, GRA and quality of life as compared with patients in the placebo group (77% vs. 16%, P<0.001). No difference was noted between the placebo and treatment groups in the voiding subscale of the NIH-CPSI. Side effects were minimal and included dizziness (7%), headache (5%) and tiredness (1%).

CONCLUSIONS: Memantine appears safe and effective in the alleviation of symptoms of chronic pelvic pan syndrome in men. Future studies should evaluate long-term treatment outcomes in larger patient cohorts.

Source of Funding: Medical University-Plovdiv, Bulgaria

340A RANDOMIZED PLACEBO-CONTROLLED MULTICENTER TRIAL OF PREGABALIN FOR THE TREATMENT OF MEN WITH CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME

Michel A Pontari*, Philadelphia, PA; John N Krieger, Seattle, WA; Mark S Litwin, Los Angeles, CA; Paige C White, Jackson, MS; Rodney U Anderson, Palo Alto, CA; Mary McNaughton-Collins, Boston, MA; J Curtis Nickel, Kingston, ONCanada; Daniel A Shoskes, Cleveland, OH; Richard B Alexander, Baltimore, MD; Robert B Nadler, Chicago, IL; Michael P O’Leary, Boston, MA; Scott Zeitlin, Los Angeles, CA; Shannon Chuai, J. Richard Landis, Philadelphia, PA; John W Kusek, Leroy M Nyberg, Bethesda, MD; Anthony J Schaeffer, Chicago, IL; The Chronic Prostatitis Collaborative Research Network(CPCRN)

INTRODUCTION AND OBJECTIVE: Although chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is the most common form of prostatitis, there is no standard therapy. Growing evidence suggests that the urogenital pain of CP/CPPS may be neuropathic in origin. The objective of this study is to determine whether pregabalin, approved for use in neuropathic pain, is effective in treating the symptoms of CP/CPPS.

METHODS: This randomized double-blind placebo controlled trial was conducted by the Chronic Prostatitis Collaborative Research Network(CPCRN) at ten centers in North America from 2006-2007. Men with pelvic pain for at least 3 of the previous 6 months, a National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score of > 15 and a non zero pain domain score were randomly assigned to either pregabalin or matching placebo in a 2:1 ratio respectively for 6 weeks. Daily pregabalin dose was increased at two week intervals beginning with 150 mg to 300 mg and finally to 600 mg. The primary endpoint was at least a 6-point decrease in the total score of the NIH-CPSI. Secondary endpoints were the Global Response Assessment (GRA), sub-scores of the NIH-CPSI (pain, urinary symptoms and quality of life), the McGill Pain Questionnaire (MPQ), Hospital Anxiety and Depression Scale (HADS), and the Sexual Health Inventory for Men (SHIM).

RESULTS: A total of 324 men were randomized. Among men assigned to pregabalin, 103/218 (47.2%) reported at least a 6-point decrease in total NIH-CPSI score at 6 weeks compared to 38/106 (35.8%) of men assigned to placebo (p=0.072, exact Mantel-Haenszel test, controlling for clinical sites). The NIH-CPSI total score decreased by a mean of 6.6 and 4.2 points (out of 43) in the pregabalin and placebo groups respectively (p=0.008). Qualitatively, similar results were observed for the three NIH-CPSI sub scores. The GRA response rate (men who reported they were markedly or moderately improved from baseline) was 31% and 19% respectively (p=0.023). The pregabalin group showed more improvement than the placebo group in the McGill total score (p=0.006) and for both the sensory (p=0.03) and the affective sub-domain (p=0.02). Results for the HADS and SHIM were not different between treatment groups.

CONCLUSIONS: Based on the primary endpoint, 6 weeks of pregabalin therapy was not superior to placebo for treating symptoms of CP/CPPS. However, the impressive differences in secondary endpoints suggest that pregabalin may prove effective in some men with long-standing CP/CPPS.

Source of Funding: NIH/NIDDK