A multicenter European epidemiological prevalence study on chronic prostatitis and chronic pelvic pain syndrome

Transcription

1 A multicenter European epidemiological prevalence study on chronic prostatitis and chronic pelvic pain syndrome Prof. Riccardo Bartoletti Department of Urology University of Florence

2 PROSTATITIS WHY? About 10% of urologic consultations Influence of prostatitis on QoL Indiscriminate use of therapies Impact of diet, patient behaviour, physical activity/sports, intestinal diseases on prostatitis

3 PROSTATITIS WHY do Italian urologists always give antibiotics to treat prostatitis when bacterial etiology is limited to 15% of cases, according to NIH classification? are different treatments planned when the disease still isn t correctly understood?

4 Multi-centre observational study of prostatitis. Characteristics of illness, incidence in the Italian population and methods of diagnostic interpretation

5 PROSTATITIS WHO? Men ranging in age between 25 and 50 yrs. Symptomatic LUTS SEXUAL PAIN and/or High level PSA (its first appearance without other objective data)

6 PROSTATITIS WHO IS EXCLUDED? Men >50 yrs. Due to increased incidence of other prostatic disease (BPH, PCa) Other relevant diseases Use of drugs or substances which could affect the typical development of the illness

7 PREVALENCE, INCIDENCE ESTIMATION, RISK FACTORS AND CHARACTERIZATION OF CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS) IN UROLOGICAL HOSPITAL OUTPATIENTS IN ITALY: RESULTS OF A MULTICENTRE CASE-CONTROL OBSERVATIONAL STUDY. Bartoletti R. et al. J Urol Dec;178(6):2411-5; discussion 2415.

8 Objectives of the observational study Definition of the incidence of prostatitis in Italy To collect anamnestic data on patients To compare subjective symptoms to different symptom scores To collect data on patients clinical evaluation (physical examination, laboratory tests, microbiological tests, other) Optional: To collect data on different kinds of treatment To collect follow-up data after 2-months of therapy

9 INCIDENCE of Prostatitis in Italy Patients enrolled 764 Healthy subjects (control group) 152 Number of patients evaluated for urological problems in outpatient offices 5540 Incidence: 13.7 % (764/5540)

10 Participating Centres (Geographic distribution)

11 Anamnestic data Patients Controls Statistical SIgnificance (p) Age (mean) p= 0.81 (range) (24-43) (28-41) Elementary school 0% 0% Mid school. 8.8% 6.9% p= 0.60 College. 62.9% 77.1% Degree 28.3% 16.0%

12 Anamnestic data Patients Controls Statistical Significance (p) Concomitant diseases 3.2% 1.8% p= 0.90 Depression 80% - Headache 15% 1% Epilepsy 5% - Anorectal diseases 7% 1% Irritative Bowel Syndrome 60% 20%

13 Anamnestic data Patients Controls Statistical Significance (p) Concomitant treatments 2.0% 1.0% p= 0.89 Antidepressant compounds 60% - Analgesics 15% 1% Carbamazepine and other 5% -

14 Lifestyle smokers Non smokers Patients 72.1% 27.9% Controls 46.3% 53.7% Statistical Significance (p) p= Alcohol use* No Alcohol use 63.0% 37.0% 51.0% 49.0% p= 0.52 * More than 4 glasses/wine/day or 1 spirits/day

15 Diet Patients Controls Statistical Significance (p) Meat/Fish/Eggs 35%/die 45 %/die p= 0.06 Milk/Milk derivates/ Cheese 28%/die 15 %/die p<0.001 Carbohydrates 45%/die 15 %/die p<0.001 Vegetables* 15%/die 35 %/die p<0.001 Fruits* 1.4 pezzi/die 3.2 pezzi/die p<0.001 Water consumption/ liquids 1500 ml 1800mL p= 0.79 Spices 79.2% 65.1% p= 0.31 Coffee/Teas 3/die 4/die p= 0.70 *relationship with prostate cancer?

16 Sexual Activity Patients Controls Statistical Significance (p) 1 partner more partners 43% 57% 64% 36% p= No contraceptive 32% 40% p= 0.65 Coitus interruptus 41% 22% p< Condom 18% 28% p= 0.73 other 9% 10% p= 0.99

17 Sexual Activity Patients Controls Statistical Significance (p) Decrease of sexual desire 14% 0% p< Evident symptoms 40% 8% p= 0.05 ED 69% 0% Premature ejaculation 31% 100%

18 Subjective abdominal symptoms Patients Controls Statistical Significance (p) Regular rectal function 21.2% 80.1% Constipation 53.2% 13.4% p< Diarroea 15.6% 5.5% Constipation/ 10.0% 1.0% Diarroea After dinner swelling 24.5% 5.5% p< Slow digestion 12.3% 8.0% p< 0.001

19 Subjective urinary symptoms Regular Micturition Frequency Patients 32% 40% Controls 100% - Statistical Significance (p) Burning Tenesmus 1% 2% - - p< Difficulty in starting to void Painful micturition 12% 13% - -

20 Subjective pain symptoms (pain site) Perineal pain Scrotal pain Suprapubic pain Abdominal pain Patients 58% 22% 12% 8% Controls

21 Subjective pain symptoms (pain frequency) Daily Weekly Monthly Patients 96% 4% - Controls - - -

22 Total PSA Patients Controls Statistical Significance (p) PSA (range) 2.8 ( ) 1.8 ( ) p= 0.06

23 Clinical Evaluation Patients Controls Statistical Significance (p) DRE 84% 2% abnormalities Prostate enlargement and tenderness 76% 1% p< Smooth surface of prostate 42% 1%

24 Symptom scores Patients Controls Statitical Significance (p) NIH Total NIH Pain NIH Urinary Symptoms p<0.001 NIH QoL IPSS Total IPSS Urinary Symptoms p< IPSS Nocturia IPSS QoL

25 Symptom scores Patients Controls Statistical Significance (p) IIEF p= 0.92 VAS No pain Low 2% 63.2% 100% - p< Moderate 14.7% - Intense 20.1% -

26 Trans Rectal Ultra Sound Patients Controls Statistical Significance (p) Rate of performance 69.3% 22.3% Prostate diameters Long 4.6 ( ) Long 4.4 ( ) (cms. e range) A-P 5.2 ( ) A-P 4.8 ( ) p= 0.48 L-L 3.8 ( ) L-L 3.6 ( ) IntraProstatic Calcifications 59.1% 1% p< 0.001

27 Microbiological analysis ( Meares-Stamey) Patients Controls Statistics (p) Positive tests 13.3% 2.9% p< 0.001

28 Pathogens Patients Controls Statistical Significance (p) Gram + 32% 11% p= Gram - 51% 89% p= Chlamydia trachomatis 8% - Ureaplasma Urealiticum 4% - Mycoplasma Hominis 4% - p< Yeasts 1% -

29 Urethral swab Patients Controls Positive test Pathogens Chlamydia T Ureaplasma U Mycoplasma H Yeasts HPV, HSV1, HSV2 6% 12% 12% 1% < 1% 74% -

30 Conclusions The incidence of prostatitis in Italy is comparable to the prevalence of the disease in other European Countries (10-14%) (Mehik A. et al. Brit.J.Urol. 86: ,2000) In patients anamnestic data we have to consider the following relevant factors : Constipation / uneven defecation Swelling after eating / slow digestion Higher diet intake of carbohydrates and lower intake of vegetables/fruits Smoking

31 Conclusions Sexual activity can influences the disease N of partners STD? Contraceptive method coitus interrupt. prostate constipaton? The disease can influence sexual activity Decreased sexual desire Erectile dysfunction and premature ejaculation

32 Conclusions The scores (NIH-CPSI, VAS, IPSS) confirmed their specific role in patients evaluation except the IIEF-5 score. The IIEF5 score was in fact originally created for patients treatment monitoring but not for andrologic patient screening

33 Conclusions The higher incidence of bacterial prostatitis can be justified by the extensive use of Meares test among patients. We found a slight presence of bacteria among the control group subjects without relevant subjective symptoms.

34 With the results obtained in the present observational study, several future clinical and more specific observational studies could be planned both in Italy and in Europe

35 A Multinational European Epidemiological Prevalence Survey on CP/CPPS Team of ESIU study: Preliminary coordinators: Riccardo Bartoletti (Italy), Aare Mehik (Finland) ESIU study panel-members: Kurt Naber (Germany), Wolfgang Weidner (Germany), Domenico Prezioso (Italy), Pierangelo Geppetti (Italy), Dr. Nesi (Italy), Margus Punab (Estonia)

36 an epidemiological prevalence survey on CP/CPPS in as many European countries as possible European urologists are asked to join the study in order to assess the burden of this disease in their countries and to improve the care of these patients

37 Primary objective To obtain data about the incidence/prevalence of CP/CPPS in different European countries during a period of 6 months with the option of a 6 months follow up in order to repeat the investigation of the patient after 3-6 months.

38 Secondary objective To analyse data on specific symptoms, lifestyle, concurrent illnesses, medications, results of medical investigations including microbiology and treatment modalities in patients with CP/CPPS.

39 Inclusion Criteria Male patients aged between years CP/CPPS symptoms for at least 3 months within the last 6 months NIH-CPSI overall scores over 14 (out of 43) Pain domain scores over 8 (out of 12) Urinary domain scores over 2 (out of 10) Quality of Life domain scores over 4 (out of 12) Basic microbiological/bacteriological localization investigations (4 or 2 glasses test with WBC and microbiology) should be performed at least once Prostate volume under 30 ml (method optional) PSA (optional) If needed, prostate biopsy must be done (3+3 or 6+6) and patients with PCa excluded

40 Exclusion Criteria Symptoms less then 3 months during the last 6 months period History of any urological tract malignancy History of urethral stricture or suspicion of this History of epididymitis during the last month Uninvestigated macrohematuria Neurological disorders of the urinary bladder History of previous prostate surgery History of antibiotic use during the last month Patients with acute bacterial prostatitis

41 Anamnestic Data Patients characteristics Diet, alcohol and smoking Concomitant diseases Sexual activity Sport activities/fitness Subjective symptoms

42 Symptoms scores NIH-CPSI Italian version IIEF 5 IPSS VAS (pain)

43 Clinical and Instrumental Evaluation Digital Rectal Examination and general clinical evaluation Trans Rectal Ultra Sound Uroflowmetry Total PSA Optional Prostatic biopsy (if tpsa greater than 2.5 ng/ml)

44 Microbiological Evaluation Meares Test Modified Meares Test (3 samples) Urethral swab (if Meares Test was negative)

45 Other data Treatment modalities Treatment is at the discretion of the specialist consulted by the patient. All data concerning treatment will be collected and registered on the appropriate evaluation form. Follow Up Patients of the follow-up study will receive all study questionnaires and another clinical and microbiological evaluation 3 or 6 months after start of treatment.

46 Data management A CD-ROM with a Microsoft Access programme set up for electronic data collection will be given to all participating centres for data collection. The forms will be installed on the hard disk of a PC at the centre with password protection (in order to protect personal data). Data about individual patients are to be entered prospectively. After enrolment the data will be copied onto a CD-ROM and sent to the centralized data management which will probably be in Italy.

47 Statistical Power in order to obtain statistically meaningful results, at least 750 patients and 150 healthy controls in larger countries or 250 patients and 50 controls in smaller countries should be enrolled

48 IN COMING within December 2008 all Centres should close the enrollment process

49 Conclusions Importance of OBSERVATIONAL STUDIES: are more suitable to provide an indication of what is achievied in daily medical practice are able to indicate specifical correlation with factors and disease are more suitable to provide an indication to plan future clinical studies

50 Conclusions OBSERVATIONAL STUDIES avoid to

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52 Thanks for your attention Claude Monet La donna con parasole e bambino