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chronic pelvic pain syndrome
49 MULTI CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PHYTOTHERAPEUTICUM PERMIXON IN THE TREATMENT OF CHRONIC PROSTATITIS/ CHRONIC PELVIC PAIN SYNDROME Rcissigl
A.‘, Pointner
Marberger
J.‘. DJavan
M.‘. Brunncr
J.‘. Obwexer
S.‘.
M.’
I.andeskrankenhaus Brcgenz. Llrology, Vienna, Austria
lNTRODUCTION endpoints (CPICPPS)
B.‘. Rcmri
Urology.
Brcgenz.
& OBJECTIVES:
in patients with chronic treated with Permixon.
Austria.
l’o evaluate
prostatitis/chronic
ofVienna.
‘University
the efficacy pelvic
and
pain
m 2 and age. was
evaluated at 6 and 12 weeks after treatment (visit 2 and 3) based on efticacy parameters mcludmg Patients Subjective Global Assessment (SGA). the total life/mlpact
Prostatitis domains
Symptom
Index (CPSI),
of the CPSI. safety
the pain, voiding
and quality
of
data. PSA and prostate volume.
2.
clinical
benefit
This multicentre
in patients
study
with Category
suggests
that Pcrmiwon
‘North Florida Urology Associates Research Institute, Inc, Urology. United States ofAmerica, ‘University of Vienna, Vienna, Austria
Gaines\
dle. FL.
INTRODUCTION & OBJECTIVES: It has been estimated that between 30.60% of men attending a prostatitis clinic have symptoms associated with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Although physicians routinely treat these symptoms with alpha-adrenoccptor antagonists. there is little sclentitic evidence suppotimg this. This study was dcsigncd to evaluate the effect of tams&sin m patients with non-bactenal CPX’PPS. MATERIAL & METHODS: A h-week, double-blind study in males (5 55 years) with a diagnosis of CPICPPS. Patients were randomised to once daily tamsulosin 0.4 mg or placebo, after a 2-week smgle-blind wash-out period. A validated index, the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), contammg 3 domains (pain, urinary symptoms and quality of life (QoL)/impact). was used. Patients with an overall NIH-CPSI score > I5 (out of 43 points) and a pain domain score > 8 (out of 21) during the screening phase were eligible. Primary parameter: change from baseline in overall NIH-CPSI at Day 45. Secondary end-points Included the 3 domain5 of the NIH-CPSI and an Invcstlgator’s (ilobal Assessment of the patient’s condition I-clativc to hatclinc. RESULTS: 57 patlcnts (age bctwccn 2 l-56 ycarr) mcrc included in the analysis (n=27 on tamsulosm
and n=30 on placebo). (figure).
of prostatitis at barcllnc
RESULTS: 52 patients were enrolled (27 Permixon; 25 control group). 75% of the Permixon group compared to 20% of the control group had at least mild improvement. 55% of Permixon patients compared to 160/o of control patients reported moderate or marked improvement. At visit 2, patients treated with Permixon showed a 30% reduction in total NIH-CPSI. No difference was observed at visit 3. Prostate volume did not change significantly in both groups. In the control group PSA did not differ from Baseline. Subjects on Permixon at visit experienced median decreases from Baseline in PSA of 22”/n. respectively
CONCl,USIONS:
Narayan P.‘. Diavan B.’
safety
syndrome
MATERIAL & METHODS: Men with Category IIIB CPPS enrolled institutions were randomised to Permixon (6 weeks active treatment) matched with a control group. Both groups uere comparable in terms of prostate volume and prostate-specific antigen (PSA). The response to therapy
NIH Chronic
50 TAMSULOSIN IS EFFECTIVE IN PATIENTS WITH NON-BACTERIAL CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME
may pro\idc
IIIB CPPS.
Response to treatment was related to the severity
The higher the haselinc severity, the higher the change rl,.,l”~l,ans.,r,,,,r.r.r I.,,I,“““lSll~l”~ 1 from baseline with tams&sin, as compared to placebo 1(1” T?l,TO,“iilO,. .P,.,rnl 1 For men with a baseline NIH-CPSI overall score > 1 > Ia ; 26.3, the dlffcrencc from placebo (at Day 45) was -3.6 .I t (p=O.O404). For patients with severe prostatitis at l .I ‘-“-ll i baseline (overall NIH-CPSI score 2 30). the difference .<..“’ I- i from placeho (at Day 45) was -7.3 (p=O.O014), which is 1 considered a clinically significant response. For the ..^.~_..._^ ^--^_,x ,. . NIH-CPSI sub-scores pam, urinary symptoms and QoL and impact. similar results were seen. Tamsulosin was well tolerated in this patient group. CONCLCISIONS: potentially &ccti\c syndrome
l’lus study suggest\ iI-carmcnt f(Jr patlcnt\
that tamsuloSm 1s a well-tolerated and u~th chrome pro\tatlti\‘chronlc pclbic pain
51 TECHNIQUE FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS IN THE EPS OF PATIENTS WITH PROSTATITIS USING CYTOMORPHOLOGICAL, METHODS
A NEW
Sofras F.‘. I‘qakanika
K
. Sopllidls
0.‘. Mpogrls
Cnlv. of Athens Med. School, 2nd Dept. ‘Sismanoglio Hospital, Cytology Department. ilospltal, MIcrobiology Lab, Athens. (ircecc
S ‘. Martsoukou
STAMEY-MEARES TEST IN CHRONIC STILL A VALID PROCEDURE?
INTRODUCTION
DIAGNOSIS.
IS
& OBJECTIVES: To check the role of scmcn cultuu
rcgmcntcd urtnc cultures tnclndmg ‘;tamey-Meares in bacterial chmmc
INTRODUCTION & OBJECTIVES: C‘hlamydia Trachomatis infection 15 a very common sexually transmitted disease easily detected in the female in the smear of a PAP test. It may also be detected using culture on McCoy medium, by direct immunofluorescent array (DFA), enzyme immunoassay (EIA). nucleic acid amplification tests (NAAT) like polymcrasc chain reaction (PCR) and ligdse chain reaction (LCR). We describe an entirely new method of detecting Chl. Tr. in the cxprcsscd prostatic spccimcn of male patients using cytomorphology.
.MATERIAL & METHODS: In 72 pauents tiho attended the dcpartmem for “Prostatitis”, DFA. and culture of the expressed prostatic secretion (EPS) was Performed. At this time a drop of EPS uas prcparcd and fixed on a glass slide as for standard cytology. The \lide was stained with tl tt. RESULTS: Of the 72 patients 55 were positive for Chl. Tr. using DFA. The morphology of the prostatic cells allo\ved us to identify SO patients with c‘hl TI-. infection. epithelial
PROSTATITIS
M.
of Urology. Athens. (ircccc. Athem. Greece. ‘Siamanoglio
(A prostatic Chl. Tr.)
52
cell infected
with
CONCLUSIONS: Cytology of the EPS can be a very reliable test to diagnose Chl Tr. infection. It is extremely cheap and requires only standard techniques and a
capable cytologist. We recommend that the EPS of patients with “prostatitis” IS alway examined by this method
cxprcsscd prortatiti\
prostate sccrction diagno\i\.
cc~sus (FPS) dcscrlhcd by
MATERIAL & METHODS: WC rctrospcctlvcly cxammed 895 parlcnts with ages between 17-67 years old consulting by suggestive symptomatology: 50, I % dysuria and/or permeal discomfort, 37.4% infertility of unknown etiology. 12.5% erectlle &ftmctlon A segmented urine culture includmg EPS and semen culture was ~pcrformcd ttr all thc\c pntlcnts. RESULTS: ~~-otma totalof644 posm\e cultt~~cs. IX7 were posltl\c for (iram -micro organism (k. cob wab the 11105t common spccunen 15olated; 70,4%) and 457 \+ere positibc for Gram 1(S.cpidcrmldis: 46,I”h). In the series of 644 po\itivc cultures 465 \\crc consldcred significant. and WC compared the culture result in EPS sample \h lth the semen sample. In those CB~L‘S where tPS could not be obtained. wc carned out the comparl\on \\irh postmasaagc urine barnpIe (VB3) In Gram group a rotal of IX2 \Igntficant cultures wcrc obtalncd, 32 patlcnts mere diagnosed hy means of \cmcn culture (negative FPS and’or VB3) and in only 5 cases a posttibc of rhc casts dlagnosls was made in spltc of a ncgatnc semen culture (posltivc EPS and/or VB3). In Ihe resl dlagnosls was performed with the aid of both: EPS-VB3 and semen. In the Gram I group (283 Ggnificant cultures), thcrc was a significant growth of such micro organisms in semen in every case considered positive. but only in 46 casts diagnosis was achicvcd via tPS and/or VB3. A chronic prostatitis diagnosis by Gram + in those patients was only considered when the same microorganism was retrieved m repeated cultures without previous treatment. Only 4 casts met such criteria (all of them with Inegative EPS). To evaluate the diagnosis efficiency of the semen and EPS samples. we analysed the sensitivity and specificity of both, obtaming tugher sensitivity m >emcn than in EPS samples for Gram (97% us. 82,4%). In Gram + cases. the \cnsitlvtty in scmcn samples was loo%,. being EPS \cnsitivity only 16.1%. CONCLUSIONS:
A bcmen sample has higher sensltl\uy
than EPS for the bacterial
chronic prostatitis diagnosis. In our climcal work-out a first-void urine (VB I ) and a ~mcn
culture arc con\idcrcd European
the only tcct nccccsary to diagnose
Urology
Supplements
a chronic prostatiti\
2 (2003) No.
1, pp. 15
A.‘, Pointner
Marberger
J.‘. DJavan
M.‘. Brunncr
J.‘. Obwexer
S.‘.
M.’
I.andeskrankenhaus Brcgenz. Llrology, Vienna, Austria
lNTRODUCTION endpoints (CPICPPS)
B.‘. Rcmri
Urology.
Brcgenz.
& OBJECTIVES:
in patients with chronic treated with Permixon.
Austria.
l’o evaluate
prostatitis/chronic
ofVienna.
‘University
the efficacy pelvic
and
pain
m 2 and age. was
evaluated at 6 and 12 weeks after treatment (visit 2 and 3) based on efticacy parameters mcludmg Patients Subjective Global Assessment (SGA). the total life/mlpact
Prostatitis domains
Symptom
Index (CPSI),
of the CPSI. safety
the pain, voiding
and quality
of
data. PSA and prostate volume.
2.
clinical
benefit
This multicentre
in patients
study
with Category
suggests
that Pcrmiwon
‘North Florida Urology Associates Research Institute, Inc, Urology. United States ofAmerica, ‘University of Vienna, Vienna, Austria
Gaines\
dle. FL.
INTRODUCTION & OBJECTIVES: It has been estimated that between 30.60% of men attending a prostatitis clinic have symptoms associated with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Although physicians routinely treat these symptoms with alpha-adrenoccptor antagonists. there is little sclentitic evidence suppotimg this. This study was dcsigncd to evaluate the effect of tams&sin m patients with non-bactenal CPX’PPS. MATERIAL & METHODS: A h-week, double-blind study in males (5 55 years) with a diagnosis of CPICPPS. Patients were randomised to once daily tamsulosin 0.4 mg or placebo, after a 2-week smgle-blind wash-out period. A validated index, the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), contammg 3 domains (pain, urinary symptoms and quality of life (QoL)/impact). was used. Patients with an overall NIH-CPSI score > I5 (out of 43 points) and a pain domain score > 8 (out of 21) during the screening phase were eligible. Primary parameter: change from baseline in overall NIH-CPSI at Day 45. Secondary end-points Included the 3 domain5 of the NIH-CPSI and an Invcstlgator’s (ilobal Assessment of the patient’s condition I-clativc to hatclinc. RESULTS: 57 patlcnts (age bctwccn 2 l-56 ycarr) mcrc included in the analysis (n=27 on tamsulosm
and n=30 on placebo). (figure).
of prostatitis at barcllnc
RESULTS: 52 patients were enrolled (27 Permixon; 25 control group). 75% of the Permixon group compared to 20% of the control group had at least mild improvement. 55% of Permixon patients compared to 160/o of control patients reported moderate or marked improvement. At visit 2, patients treated with Permixon showed a 30% reduction in total NIH-CPSI. No difference was observed at visit 3. Prostate volume did not change significantly in both groups. In the control group PSA did not differ from Baseline. Subjects on Permixon at visit experienced median decreases from Baseline in PSA of 22”/n. respectively
CONCl,USIONS:
Narayan P.‘. Diavan B.’
safety
syndrome
MATERIAL & METHODS: Men with Category IIIB CPPS enrolled institutions were randomised to Permixon (6 weeks active treatment) matched with a control group. Both groups uere comparable in terms of prostate volume and prostate-specific antigen (PSA). The response to therapy
NIH Chronic
50 TAMSULOSIN IS EFFECTIVE IN PATIENTS WITH NON-BACTERIAL CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME
may pro\idc
IIIB CPPS.
Response to treatment was related to the severity
The higher the haselinc severity, the higher the change rl,.,l”~l,ans.,r,,,,r.r.r I.,,I,“““lSll~l”~ 1 from baseline with tams&sin, as compared to placebo 1(1” T?l,TO,“iilO,. .P,.,rnl 1 For men with a baseline NIH-CPSI overall score > 1 > Ia ; 26.3, the dlffcrencc from placebo (at Day 45) was -3.6 .I t (p=O.O404). For patients with severe prostatitis at l .I ‘-“-ll i baseline (overall NIH-CPSI score 2 30). the difference .<..“’ I- i from placeho (at Day 45) was -7.3 (p=O.O014), which is 1 considered a clinically significant response. For the ..^.~_..._^ ^--^_,x ,. . NIH-CPSI sub-scores pam, urinary symptoms and QoL and impact. similar results were seen. Tamsulosin was well tolerated in this patient group. CONCLCISIONS: potentially &ccti\c syndrome
l’lus study suggest\ iI-carmcnt f(Jr patlcnt\
that tamsuloSm 1s a well-tolerated and u~th chrome pro\tatlti\‘chronlc pclbic pain
51 TECHNIQUE FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS IN THE EPS OF PATIENTS WITH PROSTATITIS USING CYTOMORPHOLOGICAL, METHODS
A NEW
Sofras F.‘. I‘qakanika
K
. Sopllidls
0.‘. Mpogrls
Cnlv. of Athens Med. School, 2nd Dept. ‘Sismanoglio Hospital, Cytology Department. ilospltal, MIcrobiology Lab, Athens. (ircecc
S ‘. Martsoukou
STAMEY-MEARES TEST IN CHRONIC STILL A VALID PROCEDURE?
INTRODUCTION
DIAGNOSIS.
IS
& OBJECTIVES: To check the role of scmcn cultuu
rcgmcntcd urtnc cultures tnclndmg ‘;tamey-Meares in bacterial chmmc
INTRODUCTION & OBJECTIVES: C‘hlamydia Trachomatis infection 15 a very common sexually transmitted disease easily detected in the female in the smear of a PAP test. It may also be detected using culture on McCoy medium, by direct immunofluorescent array (DFA), enzyme immunoassay (EIA). nucleic acid amplification tests (NAAT) like polymcrasc chain reaction (PCR) and ligdse chain reaction (LCR). We describe an entirely new method of detecting Chl. Tr. in the cxprcsscd prostatic spccimcn of male patients using cytomorphology.
.MATERIAL & METHODS: In 72 pauents tiho attended the dcpartmem for “Prostatitis”, DFA. and culture of the expressed prostatic secretion (EPS) was Performed. At this time a drop of EPS uas prcparcd and fixed on a glass slide as for standard cytology. The \lide was stained with tl tt. RESULTS: Of the 72 patients 55 were positive for Chl. Tr. using DFA. The morphology of the prostatic cells allo\ved us to identify SO patients with c‘hl TI-. infection. epithelial
PROSTATITIS
M.
of Urology. Athens. (ircccc. Athem. Greece. ‘Siamanoglio
(A prostatic Chl. Tr.)
52
cell infected
with
CONCLUSIONS: Cytology of the EPS can be a very reliable test to diagnose Chl Tr. infection. It is extremely cheap and requires only standard techniques and a
capable cytologist. We recommend that the EPS of patients with “prostatitis” IS alway examined by this method
cxprcsscd prortatiti\
prostate sccrction diagno\i\.
cc~sus (FPS) dcscrlhcd by
MATERIAL & METHODS: WC rctrospcctlvcly cxammed 895 parlcnts with ages between 17-67 years old consulting by suggestive symptomatology: 50, I % dysuria and/or permeal discomfort, 37.4% infertility of unknown etiology. 12.5% erectlle &ftmctlon A segmented urine culture includmg EPS and semen culture was ~pcrformcd ttr all thc\c pntlcnts. RESULTS: ~~-otma totalof644 posm\e cultt~~cs. IX7 were posltl\c for (iram -micro organism (k. cob wab the 11105t common spccunen 15olated; 70,4%) and 457 \+ere positibc for Gram 1(S.cpidcrmldis: 46,I”h). In the series of 644 po\itivc cultures 465 \\crc consldcred significant. and WC compared the culture result in EPS sample \h lth the semen sample. In those CB~L‘S where tPS could not be obtained. wc carned out the comparl\on \\irh postmasaagc urine barnpIe (VB3) In Gram group a rotal of IX2 \Igntficant cultures wcrc obtalncd, 32 patlcnts mere diagnosed hy means of \cmcn culture (negative FPS and’or VB3) and in only 5 cases a posttibc of rhc casts dlagnosls was made in spltc of a ncgatnc semen culture (posltivc EPS and/or VB3). In Ihe resl dlagnosls was performed with the aid of both: EPS-VB3 and semen. In the Gram I group (283 Ggnificant cultures), thcrc was a significant growth of such micro organisms in semen in every case considered positive. but only in 46 casts diagnosis was achicvcd via tPS and/or VB3. A chronic prostatitis diagnosis by Gram + in those patients was only considered when the same microorganism was retrieved m repeated cultures without previous treatment. Only 4 casts met such criteria (all of them with Inegative EPS). To evaluate the diagnosis efficiency of the semen and EPS samples. we analysed the sensitivity and specificity of both, obtaming tugher sensitivity m >emcn than in EPS samples for Gram (97% us. 82,4%). In Gram + cases. the \cnsitlvtty in scmcn samples was loo%,. being EPS \cnsitivity only 16.1%. CONCLUSIONS:
A bcmen sample has higher sensltl\uy
than EPS for the bacterial
chronic prostatitis diagnosis. In our climcal work-out a first-void urine (VB I ) and a ~mcn
culture arc con\idcrcd European
the only tcct nccccsary to diagnose
Urology
Supplements
a chronic prostatiti\
2 (2003) No.
1, pp. 15