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437Diclofenac suppository administration during transrectal ultrasound guided prostate biopsy: A randomized, placebo-controlled study
438
437 D I C L O F E N A C SUPPOSITORY ADMINISTRATION DURING TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY: A RANDOMIZED, P L A C E B O - C O N T R O L L E D STUDY
T H E E F F E C T OF R E C T A L E N E M A B E F O R E TRUS GUIDED PROSTATE BIOPSY ON PATIENT C O M F O R T AND BIOPSY RELATED COMPLICATIONS
irer B. 1, Gfilcfi A. 2, Aslan G. t, G6ktay y.2, ~elebi ?1
0zden E., ~a~atay G., Akand M., Yaman ~, Gr~/i~ O.
IDokuz Eylfil University Faculty of Medicine, Urology, Izmir, Turkey, 2Dokuz Eylfil University Faculty of Medicine, Radiology, Izmir, Turkey
Ankara University, School of Medicine, Urology, Ankara, Turkey
I N T R O D U C T I O N & OBJECTIVES: We evaluated the additional analgesic efficacy of the rectal administration of diclofenac suppository compared to placebo in patients who underwent transrectal ultrasound guided (TRUS) prostate biopsy. MATERIAL & METHODS: A total of 40 consecutive men undergoing biopsy were enrolled into this study. Patients were randomized equally two treatment groups. In group 1, patients received intrarectal 100 mg diclofenac suppository 1 hour before biopsy and in group 2, patients received glycerin suppository as a placebo intrarectally 1 hour before biopsy. All patients received 10 cc 2% lidocaine gel intrarectally 10 minutes before biopsy. The 12 sites biopsy scheme was obtained in all patients. A self administrated visual analogue scale (VAS) was used to measure the pain scores at the end of biopsy, 2 hours after and 1 day after the biopsy. RESULTS: The mean patient age was 63.3±6.8 and 61.6±6.7 in groups 1 and 2 respectively (P=0.430). The mean PSA, f/t PSA, prostate volume and PSA density were not significantly different between two groups. The mean pain scores were 3.4±1.3 versus 5.9±1.7 (P<0.0001) at the end of biopsy. The pain scores of 2 hours after the procedure were 1.2±1.0 versus 3.6±1.4 (P<0.0001) and the pain scores of 1 day after the biopsy were 0.5±0.9 versus 1.4±1.3 (P=0.017) in groups I and 2 respectively. Persistent hematuria was identified as the most common minor complication in 72.5% of patients. Any serious or drug related adverse affect was not observed during procedure.
CONCLUSIONS: Intrarectal diclofenac suppository administration is a simple, safe and helpful procedure for patients to reduce pain and to improve TRUS prostate biopsy tolerance. We recommend this procedure together with intrarectally lidocaine gel in men undergoing TRUS prostate biopsy.
I N T R O D U C T I O N & OBJECTIVES: To evaluate the effect of rectal enema before transrectai ultrasonography (TRUS)-guided prostate biopsy on patient comfort and biopsy related complications. M A T E R I A L & METHODS: A total of 100 men, who underwent TRUS-guided prostate biopsy were equally randomized into two groups. Rectal enema (1 packet of Fleet enema) was administered 1 hour before the procedure in the first group, no bowel preparation was performed in the second group. All patients had 12 core prostate biopsy. In both groups, pain scores during needle insertion and total procedure discomfort (including pre and postbiopsy phases) was assessed seperatively by an l 1-pointed visual-linear scala. One week after the biopsy patients were questioned about complications. RESULTS: There was not a statistically significant difference in mean age, PSA level and prostate volume between groups. Mean biopsy pain score was 1.72 +/1.26 in the first and 1.34 +/-1.0 in the second group (p=0.099). Mean total procedure discomfort was 2.18 +/-1.27 in the first and 1.44 +/- 0.97 in the second group (13-0.003). Complication rates were as follows in the first and second groups respectively: hemamria: 65.9%, 63.6% (p=l.0); hematospermia: 53.7%, 56.8% (p=0.941); rectal bleeding: 61%, 52.3% (p=0.555); high fever: 4.9%, 2.3% (p=0.607).
C O N C L U S I O N S : Altough biopsy pain scores between groups were not significantly different, in the group that did not use enema total procedure discomfort was significantly lower than the other. We think that use of rectal enema before biopsy increases patient discomfort because of rectal irritation, and should not be used as it also does not reduce complication rates.
440
439 R O L E OF SEXTANT P R O S T A T E B I O P S Y IN PATIENTS W I T H PROSTATE SPECIFIC ANTIGEN ABOVE 10 N G / M L AND A B N O R M A L D I G I T O R E C T A L EXAMINATION
N E W E R ARTIFICIAL N E U R A L N E T W O R K S HAVE SPECIFICITY IN P R E D I C T I N G PROSTATE C A N C E R
BETTER
Lynn N. t, Collins G. l , Lynn M. 2, Brown S. l, O'Reilly E t Luciani L., De Giorgi G., Valotto C., Zanin M., Zattoni F. ~Stepping Hill Hospital, Dept. of Urology, Stockport, United Kingdom, ZLondon Metropolitan University, Dept. of Computer Science, London, United Kingdom
University of Udine, Department of Urology, Udine, italy INTRODUCTION & OBJECTIVES: Recent studies show that standard sextant biopsy (SSB) provides inadequate prostate cancer diagnosis. A minimum of 10 to 12 cores is currently recommended in order to obtain a satisfactory detection rate. Our goal is to define whether sextant biopsy can still play a role in patients with a high clinical suspicion of prostate cancer, i.e. PSA above 10 ng/ml together with an abnormal digitorectal examination (DRE). MATERIAL & METHODS: A total of 507 patients underwent a 12-core transperineal ultrasoand-guided prostate biopsy under local anaesthesia. The first set of 6 cores was obtained as a standard sextant biopsy, integrated by 6 more cores (4 in the peripheral zone and 2 in the transition zone). Patients with clinically obvious disease or P SA > 100 ng/ml were excluded from the study. Patients were divided into 4 categories, according to PSA and digitorectal examination (DRE): 1) PSA > 10 ng/ml and an abnormal DRE; 2) PSA < 10 with abnormal DRE; 3) PSA > 10 and negative DRE or PSA > 10 and negative DRE; 4) PSA < 10 and negative DRE (table). RESULTS: The table shows the detection rate (by 12-core) and false negative SSB biopsies (6-core), in each group. The overall detection rate was 47%, with the highest rate (75%) in the group with PSA > 10 and abnormal DRE. Overall, 22 (9%) turnouts were missed by SSB, with the lowest number (3.9%) of tumours missed by SSB in the same group. In 20 of 22, the turnout was present in one core only, with a median Gleason score was 5. 1) PSA>10 DRE + Detection 76/101 rate (75%) False nega- 3/76 tive SSB (3.9%)
2) PSA<10 3 ) P S A > 1 0 DRE + DRE 78/151 36/88 (51%) (41%) 6/78 6/36 (7.6%) (16%)
4) PSA<10 DRE 52/166 (31%) 7/52 (13%)
Overall 243/507 (47%) 22/243 (9%)
CONCLUSIONS: The optimal number of cores to detect prostate cancer is yet to be defined, considering that clinical scenarios vary significantly. According to our data, a sextant prostate biopsy appeared to be adequate in patients with a high index of suspicion for prostate cancer (PSA above 10 and abnormal DRE). An initial approach with a SSB might be a safe option in such cases, especially in older or ineligible patients for surgical treatment.
European Urology Supplements 4 (2005) No. 3, pp. 112
INTRODUCTION & OBJECTIVES: Artificial neural network (ANN) has been shown to be a useful tool in predicting prostatic histology. Multilayer perceptron (MLP) is the commonly used ANN in medicine. Many network designs have been proposed as better than MLE We compared the use of these in a single population. MATERIAL & METHODS: A MLP, generalized feed forward network, modular neural network and Jordan/Ehnan network were constructed. Data from 800 men were used to train the networks with 20% cross validation. Genetic algorithms were used to find the best learning rate and optimal number of processing neurons. Variables used were age, total PSA (tPSA), total prostate volume and digital rectal examination findings. The networks were trained to predict the outcome of sextant prostate biopsies. After training, data from separate 106 men were used to test the predictive ability of these networks. The sensitivity, specificity, positive and negative predictive values of individual networks were compared. RESULTS: Mean (range) age, tPSA and TV of the test group were 68.0 (51.0-87.0) years, 9.3 (0.5-40.2) ng/ml and 61.5 (22.1-183.0) cm3. The results are shown in table elow.
tPSA (4ng/ml) MLP Jordan/Elman netwrok Modular neural netwrok General feedforward
Sensitivity
Specificity
Positive predictive value 31% 77% 82%
Negative predictive value 100% 50% 34%
100% 86% 52%
18% 36% 69%
70%
63%
184% l I
43%
50%
73%
84%
34%
CONCLUSIONS: MLP has the best sensitivity although newer networks have far better specificity than traditional MLP.
437 D I C L O F E N A C SUPPOSITORY ADMINISTRATION DURING TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY: A RANDOMIZED, P L A C E B O - C O N T R O L L E D STUDY
T H E E F F E C T OF R E C T A L E N E M A B E F O R E TRUS GUIDED PROSTATE BIOPSY ON PATIENT C O M F O R T AND BIOPSY RELATED COMPLICATIONS
irer B. 1, Gfilcfi A. 2, Aslan G. t, G6ktay y.2, ~elebi ?1
0zden E., ~a~atay G., Akand M., Yaman ~, Gr~/i~ O.
IDokuz Eylfil University Faculty of Medicine, Urology, Izmir, Turkey, 2Dokuz Eylfil University Faculty of Medicine, Radiology, Izmir, Turkey
Ankara University, School of Medicine, Urology, Ankara, Turkey
I N T R O D U C T I O N & OBJECTIVES: We evaluated the additional analgesic efficacy of the rectal administration of diclofenac suppository compared to placebo in patients who underwent transrectal ultrasound guided (TRUS) prostate biopsy. MATERIAL & METHODS: A total of 40 consecutive men undergoing biopsy were enrolled into this study. Patients were randomized equally two treatment groups. In group 1, patients received intrarectal 100 mg diclofenac suppository 1 hour before biopsy and in group 2, patients received glycerin suppository as a placebo intrarectally 1 hour before biopsy. All patients received 10 cc 2% lidocaine gel intrarectally 10 minutes before biopsy. The 12 sites biopsy scheme was obtained in all patients. A self administrated visual analogue scale (VAS) was used to measure the pain scores at the end of biopsy, 2 hours after and 1 day after the biopsy. RESULTS: The mean patient age was 63.3±6.8 and 61.6±6.7 in groups 1 and 2 respectively (P=0.430). The mean PSA, f/t PSA, prostate volume and PSA density were not significantly different between two groups. The mean pain scores were 3.4±1.3 versus 5.9±1.7 (P<0.0001) at the end of biopsy. The pain scores of 2 hours after the procedure were 1.2±1.0 versus 3.6±1.4 (P<0.0001) and the pain scores of 1 day after the biopsy were 0.5±0.9 versus 1.4±1.3 (P=0.017) in groups I and 2 respectively. Persistent hematuria was identified as the most common minor complication in 72.5% of patients. Any serious or drug related adverse affect was not observed during procedure.
CONCLUSIONS: Intrarectal diclofenac suppository administration is a simple, safe and helpful procedure for patients to reduce pain and to improve TRUS prostate biopsy tolerance. We recommend this procedure together with intrarectally lidocaine gel in men undergoing TRUS prostate biopsy.
I N T R O D U C T I O N & OBJECTIVES: To evaluate the effect of rectal enema before transrectai ultrasonography (TRUS)-guided prostate biopsy on patient comfort and biopsy related complications. M A T E R I A L & METHODS: A total of 100 men, who underwent TRUS-guided prostate biopsy were equally randomized into two groups. Rectal enema (1 packet of Fleet enema) was administered 1 hour before the procedure in the first group, no bowel preparation was performed in the second group. All patients had 12 core prostate biopsy. In both groups, pain scores during needle insertion and total procedure discomfort (including pre and postbiopsy phases) was assessed seperatively by an l 1-pointed visual-linear scala. One week after the biopsy patients were questioned about complications. RESULTS: There was not a statistically significant difference in mean age, PSA level and prostate volume between groups. Mean biopsy pain score was 1.72 +/1.26 in the first and 1.34 +/-1.0 in the second group (p=0.099). Mean total procedure discomfort was 2.18 +/-1.27 in the first and 1.44 +/- 0.97 in the second group (13-0.003). Complication rates were as follows in the first and second groups respectively: hemamria: 65.9%, 63.6% (p=l.0); hematospermia: 53.7%, 56.8% (p=0.941); rectal bleeding: 61%, 52.3% (p=0.555); high fever: 4.9%, 2.3% (p=0.607).
C O N C L U S I O N S : Altough biopsy pain scores between groups were not significantly different, in the group that did not use enema total procedure discomfort was significantly lower than the other. We think that use of rectal enema before biopsy increases patient discomfort because of rectal irritation, and should not be used as it also does not reduce complication rates.
440
439 R O L E OF SEXTANT P R O S T A T E B I O P S Y IN PATIENTS W I T H PROSTATE SPECIFIC ANTIGEN ABOVE 10 N G / M L AND A B N O R M A L D I G I T O R E C T A L EXAMINATION
N E W E R ARTIFICIAL N E U R A L N E T W O R K S HAVE SPECIFICITY IN P R E D I C T I N G PROSTATE C A N C E R
BETTER
Lynn N. t, Collins G. l , Lynn M. 2, Brown S. l, O'Reilly E t Luciani L., De Giorgi G., Valotto C., Zanin M., Zattoni F. ~Stepping Hill Hospital, Dept. of Urology, Stockport, United Kingdom, ZLondon Metropolitan University, Dept. of Computer Science, London, United Kingdom
University of Udine, Department of Urology, Udine, italy INTRODUCTION & OBJECTIVES: Recent studies show that standard sextant biopsy (SSB) provides inadequate prostate cancer diagnosis. A minimum of 10 to 12 cores is currently recommended in order to obtain a satisfactory detection rate. Our goal is to define whether sextant biopsy can still play a role in patients with a high clinical suspicion of prostate cancer, i.e. PSA above 10 ng/ml together with an abnormal digitorectal examination (DRE). MATERIAL & METHODS: A total of 507 patients underwent a 12-core transperineal ultrasoand-guided prostate biopsy under local anaesthesia. The first set of 6 cores was obtained as a standard sextant biopsy, integrated by 6 more cores (4 in the peripheral zone and 2 in the transition zone). Patients with clinically obvious disease or P SA > 100 ng/ml were excluded from the study. Patients were divided into 4 categories, according to PSA and digitorectal examination (DRE): 1) PSA > 10 ng/ml and an abnormal DRE; 2) PSA < 10 with abnormal DRE; 3) PSA > 10 and negative DRE or PSA > 10 and negative DRE; 4) PSA < 10 and negative DRE (table). RESULTS: The table shows the detection rate (by 12-core) and false negative SSB biopsies (6-core), in each group. The overall detection rate was 47%, with the highest rate (75%) in the group with PSA > 10 and abnormal DRE. Overall, 22 (9%) turnouts were missed by SSB, with the lowest number (3.9%) of tumours missed by SSB in the same group. In 20 of 22, the turnout was present in one core only, with a median Gleason score was 5. 1) PSA>10 DRE + Detection 76/101 rate (75%) False nega- 3/76 tive SSB (3.9%)
2) PSA<10 3 ) P S A > 1 0 DRE + DRE 78/151 36/88 (51%) (41%) 6/78 6/36 (7.6%) (16%)
4) PSA<10 DRE 52/166 (31%) 7/52 (13%)
Overall 243/507 (47%) 22/243 (9%)
CONCLUSIONS: The optimal number of cores to detect prostate cancer is yet to be defined, considering that clinical scenarios vary significantly. According to our data, a sextant prostate biopsy appeared to be adequate in patients with a high index of suspicion for prostate cancer (PSA above 10 and abnormal DRE). An initial approach with a SSB might be a safe option in such cases, especially in older or ineligible patients for surgical treatment.
European Urology Supplements 4 (2005) No. 3, pp. 112
INTRODUCTION & OBJECTIVES: Artificial neural network (ANN) has been shown to be a useful tool in predicting prostatic histology. Multilayer perceptron (MLP) is the commonly used ANN in medicine. Many network designs have been proposed as better than MLE We compared the use of these in a single population. MATERIAL & METHODS: A MLP, generalized feed forward network, modular neural network and Jordan/Ehnan network were constructed. Data from 800 men were used to train the networks with 20% cross validation. Genetic algorithms were used to find the best learning rate and optimal number of processing neurons. Variables used were age, total PSA (tPSA), total prostate volume and digital rectal examination findings. The networks were trained to predict the outcome of sextant prostate biopsies. After training, data from separate 106 men were used to test the predictive ability of these networks. The sensitivity, specificity, positive and negative predictive values of individual networks were compared. RESULTS: Mean (range) age, tPSA and TV of the test group were 68.0 (51.0-87.0) years, 9.3 (0.5-40.2) ng/ml and 61.5 (22.1-183.0) cm3. The results are shown in table elow.
tPSA (4ng/ml) MLP Jordan/Elman netwrok Modular neural netwrok General feedforward
Sensitivity
Specificity
Positive predictive value 31% 77% 82%
Negative predictive value 100% 50% 34%
100% 86% 52%
18% 36% 69%
70%
63%
184% l I
43%
50%
73%
84%
34%
CONCLUSIONS: MLP has the best sensitivity although newer networks have far better specificity than traditional MLP.