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The Impact of Prostate Biopsy and Periprostatic Nerve Block on Erectile and Voiding Function: A Prospective Study
The Impact of Prostate Biopsy and Periprostatic Nerve Block on Erectile and Voiding Function: A Prospective Study Tobias Klein,* Rein Jueri Palisaar, Alexander Holz, Marko Brock, Joachim Noldus and Andreas Hinkel From the Department of Urology, Ruhr-University-Bochum, Marienhospital Herne, Herne, Germany
Purpose: We evaluated the effect of multiple core prostate biopsy and periprostatic nerve block on voiding and erectile function. Materials and Methods: A total of 198 patients in whom prostate cancer was suspected were randomly assigned to undergo 10-core prostate biopsy with (71) or without (74) periprostatic nerve block. The 53 men with a history of negative prostate biopsy underwent 20-core saturation prostate biopsy with periprostatic nerve block. The International Prostate Symptom Score and International Index of Erectile Function were completed before, and 1, 4 and 12 weeks after biopsy to measure changes in voiding and erectile function, and quality of life. Upon prostate cancer diagnosis patients were excluded from further analysis. Results: The International Prostate Symptom Score was significantly increased in all patients at week 1, which persisted at weeks 4 and 12 after saturation biopsy (p ⫽ 0.007 and 0.035, respectively). After 10-core prostate biopsy with periprostatic nerve block patients had a higher International Prostate Symptom Score at weeks 4 and 12 but this was not statistically significant (p ⬎0.05). Quality of life was significantly affected at all times after saturation prostate biopsy (p ⫽ 0.001, 0.003 and 0.010, respectively). International Index of Erectile Function scores decreased significantly in all groups at week 1 (p ⬍0.05). The decrease persisted at week 4 in each 10-core prostate biopsy group. Conclusions: Prostate biopsy causes impaired voiding. Saturation prostate biopsy and periprostatic nerve block seem to have a lasting impact on voiding function. Erectile function is transiently affected by prostate biopsy regardless of periprostatic nerve block and the number of cores. Patients who undergo prostate biopsy must be informed about these side effects.
Abbreviations and Acronyms CaP ⫽ prostate cancer ED ⫽ erectile dysfunction IIEF-5 ⫽ International Index of Erectile Function I-PSS ⫽ International Prostate Symptom Score PPNB ⫽ periprostatic nerve block PSA ⫽ prostate specific antigen QOL ⫽ quality of life VAS ⫽ visual analog scale Submitted for publication February 17, 2010. Study received internal review board approval. * Correspondence: Department of Urology, Marienhospital Herne, Widumer Str. 8, 44627 Herne, Germany (telephone: ⫹ 49 2323 499 0; FAX: ⫹ 49 2323 499 385; e-mail: [email protected]).
For another article on a related topic see page 1560.
Key Words: prostate, biopsy, impotence, prostatic neoplasms, urination disorders TRANSRECTAL ultrasound guided systematic prostate biopsy has been the standard procedure to detect CaP since it was first introduced in 1989 by Hodge et al.1,2 Numerous prostate biopsy protocols with different sites and number of biopsy cores have been implemented. Extended biopsy schemes increase the CaP detection rate.3–7 Saturation biopsy may increase diag-
nostic accuracy in cases continuously suspicious for cancer despite negative biopsy.8 Although the procedure is still considered uncomfortable, the complication rate is low and biopsy is easily done in the office setting.9 –11 Especially the application of PPNB has helped make the procedure less uncomfortable.12,13
0022-5347/10/1844-1447/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 184, 1447-1452, October 2010 Printed in U.S.A. DOI:10.1016/j.juro.2010.06.021
AND
RESEARCH, INC.
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PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
Little data are available on post-prostate biopsy QOL, and erectile and voiding function. Particularly to our knowledge the influence of PPNB and saturation biopsy have not yet been evaluated in detail. To date the impact of saturation biopsy on erectile function has been addressed in only a single study.14 Several groups have noted that transient voiding impairment may be precipitated by prostate biopsy.15,16 We evaluated the impact of 10-core prostate biopsy with and without PPNB and saturation prostate biopsy on voiding and erectile function.
MATERIALS AND METHODS A total of 198 patients in whom CaP was suspected were enrolled in this study between September 2008 and January 2009. Patients undergoing initial transrectal ultrasound guided prostate biopsy were randomized into group 1—10-core biopsy without PPNB in 74, group 2—10-core biopsy with PPNB in 71 and group 3—saturation prostate biopsy (20 cores) in 53 with a history of negative prostate biopsy but suspicious PSA velocity. Indications for prostate biopsy were increased PSA 4.0 ng/ml or greater in 71, 67 and 52 men, and/or suspicious digital rectal examination in 16, 13 and 8 in groups 1 to 3, respectively. All patients received prophylactic oral antibiotics (250 mg ciprofloxacin twice daily) before biopsy and for 3 subsequent days. All patients received transrectal anesthesia with 2% lidocaine gel 15 minutes before prostate biopsy. Group 2 and 3 patients received an injection of 10 ml 2% prilocaine hydrochloride into the angle between the prostatic gland and the seminal vesicles (5 ml each) using an 18 gauge needle. All patients completed the I-PSS and IIEF-5 questionnaires before biopsy, and 1, 4 and 12 weeks later. According to I-PSS voiding symptoms were classified into 3 categories, including 7 or less—mildly, 8 to 19 —moderately and 20 to 35—severely symptomatic. Impaired QOL due to urinary symptoms was rated on a scale of 0 — delighted to 6 —terrible.17 ED severity was classified into 5 categories, including 22 to 25—none, and 17 to 21—mild, 12 to 16 —mild to moderate, 8 to 11—moderate and 5 to 7— severe ED.18 One week after biopsy pain was recorded using a VAS on a scale of 0 —no pain to 10 —maximum pain. Patients with confirmed CaP were excluded from study since most received therapy known to affect erectile and voiding function at least transiently. The study was approved by the internal review board and informed consent was obtained from all patients. Primary study end points were change in median I-PSS and IIEF-5 in the 3 groups after 1, 4 and 12 weeks compared to baseline. Secondary end points were change in QOL due to urinary symptoms and any increase in median I-PSS. Other secondary end points were evaluation of any decrease in erectile function within 3 months and a decrease in the median IIEF-5 score that led to a different category, eg from moderate to severe ED.18 We analyzed certain variables, including local anesthesia, number of cores (10 vs 20-core biopsy), pain (VAS score) and age, for an association with the primary and secondary end points.
The Student t, Wilcoxon and chi-square tests were used for statistical analysis. One-way ANOVA followed by the Tukey post hoc test was used to compare patient characteristics. Univariate and multivariate linear regression analysis was done to evaluate the influence of certain variables, including local anesthesia, number of cores, pain and age, on voiding and erectile function. All analysis was done using SPSS®, version 16 with 2-sided p ⬍0.05 considered statistically significant.
RESULTS Patients Statistical analysis of baseline patient characteristics revealed statistically significant differences among the 3 groups in patient age and prostate volume, which were clinically irrelevant (table 1). Patients with saturation biopsy had significantly higher prostate volume than groups 1 and 2 (p ⫽ 0.026 and 0.016, respectively). Differences in prostate volume and PSA in the saturation biopsy vs the 10-core prostate biopsy group were due to preselection bias, including previously negative prostate biopsy and persistently increased, suspicious PSA. CaP was detected in 80 cases (40.4%). A total of 118 CaP-free patients were further evaluated for voiding and erectile function, including 44 (37.3%) in group 1, 36 (30.5%) in group 2 and 38 (32.2%) in group 3. Complications and Pain Three patients (1.5%) diagnosed with CaP were in acute urinary retention after biopsy. Four patients had prostatitis, including 1, 2 and 1 in each of groups 1 to 3 (p ⫽ 0.693). The mean ⫾ SD VAS score was 2.56 ⫾ 2.37, including 2.41 ⫾ 2.16, 2.61 ⫾ 2.1 and 2.68 ⫾ 2.86 in groups 1 to 3, respectively (p ⫽ 0.864). Four patients (3.4%) received intravenous antibiotics for febrile prostatitis. Mild hematuria was reported by 64 patients, including 21 in group 1, 19 in group 2 and 24 in group 3 (p ⫽ 0.357), but there was no need for surgical intervention. Voiding Function Median I-PSS change. At 1 week median I-PSS was significantly higher in patients with 10 core-prostate biopsy with and without PPNB compared to base-
Table 1. Patient characteristics
Overall Biopsy alone Biopsy ⫹ PPNB Saturation biopsy p Value
Median Age
No. Ca (%)
66.1 68.5 63.8 65.7 0.001*
80 (40.4) 30 (40.5) 35 (49.2) 15 (28.3) 0.062
* Significant (p ⱕ0.05).
Median PSA Median Prostate (ng/ml) Vol (ml) 9.1 8.53 8.81 10.57 0.062
44.94 42.78 42.1 51.74 0.011*
PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
line. A persistent increase was also found in group 3 but it was not statistically significant. Patients with 10-core prostate biopsy and PPNB had increased I-PSS at weeks 4 and 12, which was also not statistically significant (table 2). Influential factors. Univariate and multivariate regression analysis revealed a correlation between the change in median I-PSS and pain on the VAS at 1 week (p ⫽ 0.021 and 0.005, respectively). This correlation was also found for any increase in I-PSS, which was a secondary end point (p ⫽ 0.021 and 0.024, respectively). An association was noted between increased median I-PSS and PPNB at 12 weeks on univariate and multivariate regression analysis (p ⫽ 0.041 and 0.030), and between any I-PSS increase and PPNB at 4 weeks (p ⫽ 0.038 and 0.006, respectively). No other variables correlated with end points (p ⬎0.05). QOL change. Overall we noted a significant change in QOL due to urinary symptoms at 1 and 4 weeks (0.31 and 0.25, respectively). Subgroup analysis revealed significant changes after 1, 4 and 12 weeks in group 3 only (table 3). Univariate regression analysis showed a correlation of impaired QOL due to urinary symptoms with PPNB and saturation biopsy at 1 and 4 weeks (p ⬍0.05). However, multivariate analysis only revealed a positive correlation with saturation prostate biopsy at 1 week and with PPNB at 4 weeks (p ⫽ 0.032 and 0.039, respectively). No association was found for impaired QOL due to urinary symptoms with PPNB or saturation biopsy at 12 weeks. Erectile Function Median IIEF-5 score change. Compared to baseline the median IIEF-5 score was significantly lower in all groups 1 week after biopsy. There were still significant differences vs baseline at 4 weeks after 10-
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Table 3. Change in QOL and IIEF-5 score within 3 months after biopsy Difference vs Baseline Baseline
Wk 1
Wk 4
Wk 12
⫺0.05 0.728 0.33 0.116 0.53 0.003 0.25 0.011*
⫺0.23 0.160 0.11 0.586 0.58 0.010 0.14 0.232
⫺5.33
⫺5.32
⫺2.11 0.037† ⫺1.53 0.119
⫺1.21 0.132 ⫺1.11 0.233
QOL Mean biopsy alone p Value Mean biopsy ⫹ PPND p Value Mean saturation biopsy p Value* Mean overall p Value Mean biopsy alone p Value Mean biopsy ⫹ PPND p Value Mean saturation biopsy p Value
1.77 1.58 1.71 1.70
0.05 0.623 0.14 0.230 0.79 0.001 0.31 0.001*
IIEF-5 score 14.73 ⫺4.18 ⬍0.001† 17.81 ⫺3.27 ⬍0.001† 15.18 ⫺1.14 0.066
* Significant (p ⬍0.05). † Significant (p ⱕ0.05).
core but not after saturation biopsy (table 3). No significant differences were found at 12 weeks. Erectile function change. There was a significant increase in severe ED5–7 1 week after prostate biopsy but not at 4 and 12 weeks. An additional 10 men (10.75%) complained about severe ED 12 weeks after prostate biopsy (table 4). Influential factors. Univariate but not multivariate regression analysis revealed a significant correlation between change in median IIEF-5 score and pain at 1 week (p ⫽ 0.032). No other variables correlated with the primary end point (p ⬎0.05). Univariate and multivariate regression analysis revealed a significant association between the decrease in median IIEF-5 score leading to a higher level of ED, eg from moderate to
Table 2. I-PSS change within 3 months after biopsy vs baseline Baseline Biopsy alone: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) Biopsy ⫹ PPNB: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) Saturation biopsy: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) * Significant (p ⬍0.05).
Wk 1
p Value
Wk 4
0.004* 9.36 22 (50) 14 (31.8) 8 (18.2)
11 18 17 9
8.39 17 (47.2) 17 (47.2) 2 (.6)
10.58 12 (33.3) 21 (58.3) 3 (8.3)
10.58 16 (42.1) 18 (47.4) 4 (10.5)
11.89 14 (36.8) 17 (44.7) 7 (18.4)
p Value 0.147
10.14 23 (52.3) 14 (31.8) 7 (15.9)
(40.9) (38.6) (20.5)
Wk 12
0.001*
0.670 9.32 24 (54.5) 10 (22.7) 10 (22.7)
0.094 9.97 15 (41.7) 15 (41.7) 6 (16.7)
0.051
0.088 10.22 16 (44.4) 14 (38.9) 6 (16.7)
0.007* 12.39 12 (31.6) 18 (47.4) 8 (21.1)
p Value
0.035* 12.66 11 (28.9) 16 (42.1) 11 (28.9)
0.035*
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PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
Table 4. Patients in ED categories at baseline, and 1, 4 and 12 weeks after biopsy ED Degree Biopsy alone: None Mild Mild-moderate Moderate Severe Biopsy ⫹ PPNB: None Mild Mild-moderate Moderate Severe Saturation biopsy: None Mild Mild-moderate Moderate Severe
No. Baseline (%)
No. Wk 1 (%)
p Value
No. Wk 4 (%)
p Value
No. Wk 12 (%)
p Value
13 (29.5) 10 (22,7) 6 (13.6) 3 (6.8) 12 (27.3)
6 (13.6) 9 (20.5) 5 (11.4) 1 (2.3) 23 (52.3)
0.119 1 1 0.616 0.028*
6 (13.6) 9 (20.5) 5 (11.4) 6 (13.6) 18 (40.9)
0.119 1 1 0.484 0.261
10 (22.7) 13 (29.5) 3 (6.8) 3 (6.8) 15 (34.1)
0.628 0.628 0.484 1 0.644
13 (36.1) 12 (33.3) 7 (19.4) 0 4 (11.2)
5 (13.9) 8 (22.2) 6 (16.7) 3 (8.3) 14 (38.9)
0.055 0.430 0.771 0.120 0.013*
12 (33.3) 7 (19.4) 7 (19.4) 1 (2.8) 9 (25.1)
0.811 0.285 1 1 0.220
13 (36.1) 6 (16.7) 8 (22.2) 2 (5.6) 7 (19.4)
1 0.173 1 0.493 0.515
13 (34.2) 5 (13.2) 4 (10.5) 7 (18.4) 9 (23.7)
7 (18.4) 3 (7.9) 2 (5.3) 6 (15.8) 20 (52.6)
0.192 0.711 0.675 0.772 0.018*
14 (36.8) 4 (10.5) 5 (13.2) 2 (5.3) 13 (34.2)
1 1 1 0.091 0.449
13 (34.2) 6 (15.8) 1 (2.6) 5 (13.2) 13 (24.2)
1 1 0.358 0.550 0.449
* Significant (p ⱕ0.05).
severe ED, and pain (univariate and multivariate p ⫽ 0.021 and 0.037, respectively). Any decrease in erectile function after 1 week also correlated with pain on univariate analysis (p ⫽ 0.034).
DISCUSSION Most studies of peri-interventional complications associated with prostate biopsy have focused on pain, hematuria and prostatitis.19,20 There are few publications of impaired voiding function and QOL aspects, eg erectile function.21 We found a significant increase in mean I-PSS in groups 1 to 3 (1.64, 2.19 and 1.31, respectively) 1 week after prostate biopsy. This resolved within the following 12 weeks in patients with 10-core biopsy with and without PPNB but not in those with saturation biopsy. We also found a transient decrease in IIEF-5 scores in groups 1 to 3 (⫺4.18, ⫺3.27 and ⫺1.14, respectively). Four weeks after prostate biopsy we noted a significant decrease in patients with 10-core biopsy with and without PPNB, which resolved after 3 months. We found no evidence of a persistent influence of certain factors, including local anesthesia, number of cores or age, on erectile function in any group but there was an association of transient ED with pain. In 2001 Zisman et al first described in detail the influence of prostate biopsy on patient general wellbeing, considering pain, voiding and erectile function.15,21 They delivered topical anesthesia with 2% lidocaine gel transrectally before prostate biopsy but did not use PPNB. They concluded that prostate biopsy has a measurable impact on voiding function. The larger the transition zone, the more likely prostate biopsy is to be associated with subjective symp-
toms and urinary retention. Thus, they recommended that patients with baseline I-PSS greater than 20 and transition zone volume greater than 42 ml be informed about the increased risk of impaired voiding. We could not substantiate this observation since we detected no correlation between increased I-PSS and prostate volume. In the series by Zisman et al 11 of 167 patients (7%) reported de novo ED when they were informed about the need for prostate biopsy and the problem persisted in 4.21 After biopsy some patients reported transient ED. Those with persistent ED had a higher anxiety. To our knowledge whether local damage to the neurovascular bundle or a psychological impact was responsible for ED remains an open question. Although our patients were not explicitly interviewed about anxiety, 5 reported severe anxiety about harboring CaP during the 3 to 5-day interval waiting for the final histopathological biopsy results. Libido was decreased during week 1, as substantiated by decreased median IIEF-5 and increased VAS scores. Thus, the psychological impact of an imminent cancer diagnosis and the pain experienced during biopsy seem to have an important role in transient ED after prostate biopsy. Bozlu et al noted transiently impaired voiding function until post-prostate biopsy day 30.16 Thus, they suggested medication with tamsulosin before and for a brief time after biopsy. All 66 patients underwent 12-core prostate biopsy with PPNB. The impact of the number of cores and PPNB on voiding function was not evaluated but QOL was altered by voiding symptoms. Significant impairment, as in our series, was not observed.
PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
In 2006 Chrisofos et al reported ED after prostate biopsy.22 At biopsy 10 ml 2% lidocaine gel topical anesthesia were applied transrectally but PPNB was not used. No significant difference in erectile function was found 4 and 12 weeks after biopsy. Of previously potent men 9% reported persistent ED 3 months after biopsy. In our study population an additional 10 men (10.75%) complained about severe ED 3 months after biopsy. However, the difference was not significant on subgroup analysis. Patients with severe ED after biopsy had already had mild to moderate ED before biopsy. Thus, we advocate that patients with preexisting ED must be informed about the risk of worsening ED. Akbal et al performed saturation prostate biopsy in 150 patients.14 Median IIEF score was unchanged in 88 CaP-free patients followed for 6 months. However, 1 month after prostate biopsy 36 of 74 patients with no or mild ED before prostate biopsy had progressed to mild or moderate ED (p ⫽ 0.01). This difference resolved after 6 months. Notable saturation biopsy was done using general anesthesia in all throughout the study. Similar to our findings, there was no correlation between transient ED, age or number of biopsy cores but there was transiently impaired erectile function. Only Tuncel et al found a significant difference between prebiopsy and 6-month post-biopsy IIEF-5 scores.23 They also evaluated the impact on female sexual function and detected a significant impact even after 6 months. To our knowledge our study is the first to evaluate the impact of the number of biopsy cores and PPNB on voiding function and potency. Erectile function is not significantly influenced by these factors and biopsy can be done with low risk. In addition to previous studies, we noted that impaired QOL due to urinary symptoms seems to be associated with an
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increased number of biopsy cores and with PPNB. We found a measurable yet transient impact on voiding and erectile function in patients with 10core prostate biopsy with and without PPNB, which was more pronounced and durable after saturation prostate biopsy with PPNB. Regarding underlying pathophysiology, our data show that any additional measure over the standard prostate biopsy regimen (10 vs 20 cores and PPNB vs no PPNB) causes impaired voiding until week 1, which persists in patients with 20-core prostate biopsy and PPNB. Thus, we propose that increasing the number of biopsy cores and PPNB irritate the neurovascular bundle, resulting in impaired voiding and erectile function. Our assumption is indirectly supported by the fact that, in addition to preventing erection loss, preserving the neurovascular bundle at radical prostatectomy positively influences early postoperative continence.24,25
CONCLUSIONS Transrectal ultrasound guided prostate biopsy is well tolerated, especially when combined with local anesthesia. However, PPNB causes voiding problems, which resolve 1 to 4 weeks after prostate biopsy. Erectile function is transiently impaired after prostate biopsy regardless of PPNB and the number of cores. Impairment is reversible within 3 months. PPNB does not cause permanent damage to the neurovascular bundle. Patient age, the number of cores and local anesthesia have no lasting impact on erectile function but further evaluation is needed to evaluate the psychological influence on erectile function. Before prostate biopsy patients should be informed about a transient detriment in erectile function and worsening preexisting ED. Those who undergo saturation prostate biopsy must be informed about the risk of prolonged difficult voiding.
REFERENCES 1. Hodge K, McNeal J, Terris M et al: Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol 1989; 142: 71.
5. Babaian R, Toi A, Kamoi K et al: A comparative analysis of sextant and an extended 11-core multisite directed biopsy strategy. J Urol 2000; 163: 152.
2. Hodge K, McNeal J and Stamey T: Ultrasound guided transrectal core biopsies of the palpably abnormal prostate. J Urol 1989; 142: 66.
6. Durkan G, Sheikh N, Johnson P et al: Improving prostate cancer detection with an extended-core transrectal ultrasonography-guided prostate biopsy protocol. BJU Int 2002; 89: 33.
3. Eskew L, Bare R and McCullough D: Systematic 5 region prostate biopsy is superior to sextant method for diagnosing carcinoma of the prostate. J Urol 1997; 157: 199. 4. Levine M, Ittman M, Melamed J et al: Two consecutive sets of transrectal ultrasound guided sextant biopsies of the prostate for the detection of prostate cancer. J Urol 1998; 159: 471.
7. Presti JJ, Chang J, Bhargava V et al: The optimal systematic prostate biopsy scheme should include 8 rather than 6 biopsies: results of a prospective clinical trial. J Urol 2000; 163: 163. 8. Boccon-Gibod L, de Longchamps N, Toublanc M et al: Prostate saturation biopsy in the reevalua-
tion of microfocal prostate cancer. J Urol 2006; 176: 961. 9. Raaijmakers R, Kirkels W, Roobol M et al: Complication rates and risk factors of 5802 transrectal ultrasound-guided sextant biopsies of the prostate within a population-based screening program. Urology 2002; 60: 826. 10. Stewart C, Leibovich B, Weaver A et al: Prostate cancer diagnosis using a saturation needle biopsy technique after previous negative sextant biopsies. J Urol 2001; 166: 86. 11. Collins G, Lloyd S, Hehir M et al: Multiple transrectal ultrasound-guided prostatic biopsies—true morbidity and patient acceptance. Br J Urol 1993; 71: 460.
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12. von Knobloch R, Weber J, Varga Z et al: Bilateral fine-needle administered local anaesthetic nerve block for pain control during TRUS-guided multicore prostate biopsy: a prospective randomised trial. Eur Urol 2002; 41: 508.
17. Barry M, Fowler FJ, O’Leary M et al: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 1992; 148: 1549.
13. Jones J, Oder M and Zippe C: Saturation prostate biopsy with periprostatic block can be performed in office. J Urol 2002; 168: 2108.
18. Rosen R, Cappelleri J, Smith M et al: Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999; 11: 319.
14. Akbal C, Türker P, Tavukçu H et al: Erectile function in prostate cancer-free patients who underwent prostate saturation biopsy. Eur Urol 2008; 53: 540. 15. Zisman A, Leibovici D, Kleinmann J et al: The impact of prostate biopsy on patient well-being: a prospective study of voiding impairment. J Urol 2001; 166: 2242. 16. Bozlu M, Ulusoy E, Doruk E et al: Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology 2003; 62: 1050.
19. Rodríguez L and Terris M: Risks and complications of transrectal ultrasound guided prostate needle biopsy: a prospective study and review of the literature. J Urol 1998; 160: 2115. 20. Rietbergen J, Kruger A, Kranse R et al: Complications of transrectal ultrasound-guided systematic sextant biopsies of the prostate: evaluation of complication rates and risk factors within a population-based screening program. Urology 1997; 49: 875.
21. Zisman A, Leibovici D, Kleinmann J et al: The impact of prostate biopsy on patient well-being: a prospective study of pain, anxiety and erectile dysfunction. J Urol 2001; 165: 445. 22. Chrisofos M, Papatsoris A, Dellis A et al: Can prostate biopsies affect erectile function? Andrologia 2006; 38: 79. 23. Tuncel A, Kirilmaz U, Nalcacioglu V et al: The impact of transrectal prostate needle biopsy on sexuality in men and their female partners. Urology 2008; 71: 1128. 24. Abel E, Masterson T, Warner J et al: Nervesparing prostatectomy and urinary function: a prospective analysis using validated quality-oflife measures. Urology 2009; 73: 1336. 25. Burkhard F, Kessler T, Fleischmann A et al: Nerve sparing open radical retropubic prostatectomy— does it have an impact on urinary continence? J Urol 2006; 176: 189.
Purpose: We evaluated the effect of multiple core prostate biopsy and periprostatic nerve block on voiding and erectile function. Materials and Methods: A total of 198 patients in whom prostate cancer was suspected were randomly assigned to undergo 10-core prostate biopsy with (71) or without (74) periprostatic nerve block. The 53 men with a history of negative prostate biopsy underwent 20-core saturation prostate biopsy with periprostatic nerve block. The International Prostate Symptom Score and International Index of Erectile Function were completed before, and 1, 4 and 12 weeks after biopsy to measure changes in voiding and erectile function, and quality of life. Upon prostate cancer diagnosis patients were excluded from further analysis. Results: The International Prostate Symptom Score was significantly increased in all patients at week 1, which persisted at weeks 4 and 12 after saturation biopsy (p ⫽ 0.007 and 0.035, respectively). After 10-core prostate biopsy with periprostatic nerve block patients had a higher International Prostate Symptom Score at weeks 4 and 12 but this was not statistically significant (p ⬎0.05). Quality of life was significantly affected at all times after saturation prostate biopsy (p ⫽ 0.001, 0.003 and 0.010, respectively). International Index of Erectile Function scores decreased significantly in all groups at week 1 (p ⬍0.05). The decrease persisted at week 4 in each 10-core prostate biopsy group. Conclusions: Prostate biopsy causes impaired voiding. Saturation prostate biopsy and periprostatic nerve block seem to have a lasting impact on voiding function. Erectile function is transiently affected by prostate biopsy regardless of periprostatic nerve block and the number of cores. Patients who undergo prostate biopsy must be informed about these side effects.
Abbreviations and Acronyms CaP ⫽ prostate cancer ED ⫽ erectile dysfunction IIEF-5 ⫽ International Index of Erectile Function I-PSS ⫽ International Prostate Symptom Score PPNB ⫽ periprostatic nerve block PSA ⫽ prostate specific antigen QOL ⫽ quality of life VAS ⫽ visual analog scale Submitted for publication February 17, 2010. Study received internal review board approval. * Correspondence: Department of Urology, Marienhospital Herne, Widumer Str. 8, 44627 Herne, Germany (telephone: ⫹ 49 2323 499 0; FAX: ⫹ 49 2323 499 385; e-mail: [email protected]).
For another article on a related topic see page 1560.
Key Words: prostate, biopsy, impotence, prostatic neoplasms, urination disorders TRANSRECTAL ultrasound guided systematic prostate biopsy has been the standard procedure to detect CaP since it was first introduced in 1989 by Hodge et al.1,2 Numerous prostate biopsy protocols with different sites and number of biopsy cores have been implemented. Extended biopsy schemes increase the CaP detection rate.3–7 Saturation biopsy may increase diag-
nostic accuracy in cases continuously suspicious for cancer despite negative biopsy.8 Although the procedure is still considered uncomfortable, the complication rate is low and biopsy is easily done in the office setting.9 –11 Especially the application of PPNB has helped make the procedure less uncomfortable.12,13
0022-5347/10/1844-1447/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 184, 1447-1452, October 2010 Printed in U.S.A. DOI:10.1016/j.juro.2010.06.021
AND
RESEARCH, INC.
www.jurology.com
1447
1448
PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
Little data are available on post-prostate biopsy QOL, and erectile and voiding function. Particularly to our knowledge the influence of PPNB and saturation biopsy have not yet been evaluated in detail. To date the impact of saturation biopsy on erectile function has been addressed in only a single study.14 Several groups have noted that transient voiding impairment may be precipitated by prostate biopsy.15,16 We evaluated the impact of 10-core prostate biopsy with and without PPNB and saturation prostate biopsy on voiding and erectile function.
MATERIALS AND METHODS A total of 198 patients in whom CaP was suspected were enrolled in this study between September 2008 and January 2009. Patients undergoing initial transrectal ultrasound guided prostate biopsy were randomized into group 1—10-core biopsy without PPNB in 74, group 2—10-core biopsy with PPNB in 71 and group 3—saturation prostate biopsy (20 cores) in 53 with a history of negative prostate biopsy but suspicious PSA velocity. Indications for prostate biopsy were increased PSA 4.0 ng/ml or greater in 71, 67 and 52 men, and/or suspicious digital rectal examination in 16, 13 and 8 in groups 1 to 3, respectively. All patients received prophylactic oral antibiotics (250 mg ciprofloxacin twice daily) before biopsy and for 3 subsequent days. All patients received transrectal anesthesia with 2% lidocaine gel 15 minutes before prostate biopsy. Group 2 and 3 patients received an injection of 10 ml 2% prilocaine hydrochloride into the angle between the prostatic gland and the seminal vesicles (5 ml each) using an 18 gauge needle. All patients completed the I-PSS and IIEF-5 questionnaires before biopsy, and 1, 4 and 12 weeks later. According to I-PSS voiding symptoms were classified into 3 categories, including 7 or less—mildly, 8 to 19 —moderately and 20 to 35—severely symptomatic. Impaired QOL due to urinary symptoms was rated on a scale of 0 — delighted to 6 —terrible.17 ED severity was classified into 5 categories, including 22 to 25—none, and 17 to 21—mild, 12 to 16 —mild to moderate, 8 to 11—moderate and 5 to 7— severe ED.18 One week after biopsy pain was recorded using a VAS on a scale of 0 —no pain to 10 —maximum pain. Patients with confirmed CaP were excluded from study since most received therapy known to affect erectile and voiding function at least transiently. The study was approved by the internal review board and informed consent was obtained from all patients. Primary study end points were change in median I-PSS and IIEF-5 in the 3 groups after 1, 4 and 12 weeks compared to baseline. Secondary end points were change in QOL due to urinary symptoms and any increase in median I-PSS. Other secondary end points were evaluation of any decrease in erectile function within 3 months and a decrease in the median IIEF-5 score that led to a different category, eg from moderate to severe ED.18 We analyzed certain variables, including local anesthesia, number of cores (10 vs 20-core biopsy), pain (VAS score) and age, for an association with the primary and secondary end points.
The Student t, Wilcoxon and chi-square tests were used for statistical analysis. One-way ANOVA followed by the Tukey post hoc test was used to compare patient characteristics. Univariate and multivariate linear regression analysis was done to evaluate the influence of certain variables, including local anesthesia, number of cores, pain and age, on voiding and erectile function. All analysis was done using SPSS®, version 16 with 2-sided p ⬍0.05 considered statistically significant.
RESULTS Patients Statistical analysis of baseline patient characteristics revealed statistically significant differences among the 3 groups in patient age and prostate volume, which were clinically irrelevant (table 1). Patients with saturation biopsy had significantly higher prostate volume than groups 1 and 2 (p ⫽ 0.026 and 0.016, respectively). Differences in prostate volume and PSA in the saturation biopsy vs the 10-core prostate biopsy group were due to preselection bias, including previously negative prostate biopsy and persistently increased, suspicious PSA. CaP was detected in 80 cases (40.4%). A total of 118 CaP-free patients were further evaluated for voiding and erectile function, including 44 (37.3%) in group 1, 36 (30.5%) in group 2 and 38 (32.2%) in group 3. Complications and Pain Three patients (1.5%) diagnosed with CaP were in acute urinary retention after biopsy. Four patients had prostatitis, including 1, 2 and 1 in each of groups 1 to 3 (p ⫽ 0.693). The mean ⫾ SD VAS score was 2.56 ⫾ 2.37, including 2.41 ⫾ 2.16, 2.61 ⫾ 2.1 and 2.68 ⫾ 2.86 in groups 1 to 3, respectively (p ⫽ 0.864). Four patients (3.4%) received intravenous antibiotics for febrile prostatitis. Mild hematuria was reported by 64 patients, including 21 in group 1, 19 in group 2 and 24 in group 3 (p ⫽ 0.357), but there was no need for surgical intervention. Voiding Function Median I-PSS change. At 1 week median I-PSS was significantly higher in patients with 10 core-prostate biopsy with and without PPNB compared to base-
Table 1. Patient characteristics
Overall Biopsy alone Biopsy ⫹ PPNB Saturation biopsy p Value
Median Age
No. Ca (%)
66.1 68.5 63.8 65.7 0.001*
80 (40.4) 30 (40.5) 35 (49.2) 15 (28.3) 0.062
* Significant (p ⱕ0.05).
Median PSA Median Prostate (ng/ml) Vol (ml) 9.1 8.53 8.81 10.57 0.062
44.94 42.78 42.1 51.74 0.011*
PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
line. A persistent increase was also found in group 3 but it was not statistically significant. Patients with 10-core prostate biopsy and PPNB had increased I-PSS at weeks 4 and 12, which was also not statistically significant (table 2). Influential factors. Univariate and multivariate regression analysis revealed a correlation between the change in median I-PSS and pain on the VAS at 1 week (p ⫽ 0.021 and 0.005, respectively). This correlation was also found for any increase in I-PSS, which was a secondary end point (p ⫽ 0.021 and 0.024, respectively). An association was noted between increased median I-PSS and PPNB at 12 weeks on univariate and multivariate regression analysis (p ⫽ 0.041 and 0.030), and between any I-PSS increase and PPNB at 4 weeks (p ⫽ 0.038 and 0.006, respectively). No other variables correlated with end points (p ⬎0.05). QOL change. Overall we noted a significant change in QOL due to urinary symptoms at 1 and 4 weeks (0.31 and 0.25, respectively). Subgroup analysis revealed significant changes after 1, 4 and 12 weeks in group 3 only (table 3). Univariate regression analysis showed a correlation of impaired QOL due to urinary symptoms with PPNB and saturation biopsy at 1 and 4 weeks (p ⬍0.05). However, multivariate analysis only revealed a positive correlation with saturation prostate biopsy at 1 week and with PPNB at 4 weeks (p ⫽ 0.032 and 0.039, respectively). No association was found for impaired QOL due to urinary symptoms with PPNB or saturation biopsy at 12 weeks. Erectile Function Median IIEF-5 score change. Compared to baseline the median IIEF-5 score was significantly lower in all groups 1 week after biopsy. There were still significant differences vs baseline at 4 weeks after 10-
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Table 3. Change in QOL and IIEF-5 score within 3 months after biopsy Difference vs Baseline Baseline
Wk 1
Wk 4
Wk 12
⫺0.05 0.728 0.33 0.116 0.53 0.003 0.25 0.011*
⫺0.23 0.160 0.11 0.586 0.58 0.010 0.14 0.232
⫺5.33
⫺5.32
⫺2.11 0.037† ⫺1.53 0.119
⫺1.21 0.132 ⫺1.11 0.233
QOL Mean biopsy alone p Value Mean biopsy ⫹ PPND p Value Mean saturation biopsy p Value* Mean overall p Value Mean biopsy alone p Value Mean biopsy ⫹ PPND p Value Mean saturation biopsy p Value
1.77 1.58 1.71 1.70
0.05 0.623 0.14 0.230 0.79 0.001 0.31 0.001*
IIEF-5 score 14.73 ⫺4.18 ⬍0.001† 17.81 ⫺3.27 ⬍0.001† 15.18 ⫺1.14 0.066
* Significant (p ⬍0.05). † Significant (p ⱕ0.05).
core but not after saturation biopsy (table 3). No significant differences were found at 12 weeks. Erectile function change. There was a significant increase in severe ED5–7 1 week after prostate biopsy but not at 4 and 12 weeks. An additional 10 men (10.75%) complained about severe ED 12 weeks after prostate biopsy (table 4). Influential factors. Univariate but not multivariate regression analysis revealed a significant correlation between change in median IIEF-5 score and pain at 1 week (p ⫽ 0.032). No other variables correlated with the primary end point (p ⬎0.05). Univariate and multivariate regression analysis revealed a significant association between the decrease in median IIEF-5 score leading to a higher level of ED, eg from moderate to
Table 2. I-PSS change within 3 months after biopsy vs baseline Baseline Biopsy alone: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) Biopsy ⫹ PPNB: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) Saturation biopsy: Mean I-PSS No. mildly symptomatic (%) No. moderately symptomatic (%) No. severely symptomatic (%) * Significant (p ⬍0.05).
Wk 1
p Value
Wk 4
0.004* 9.36 22 (50) 14 (31.8) 8 (18.2)
11 18 17 9
8.39 17 (47.2) 17 (47.2) 2 (.6)
10.58 12 (33.3) 21 (58.3) 3 (8.3)
10.58 16 (42.1) 18 (47.4) 4 (10.5)
11.89 14 (36.8) 17 (44.7) 7 (18.4)
p Value 0.147
10.14 23 (52.3) 14 (31.8) 7 (15.9)
(40.9) (38.6) (20.5)
Wk 12
0.001*
0.670 9.32 24 (54.5) 10 (22.7) 10 (22.7)
0.094 9.97 15 (41.7) 15 (41.7) 6 (16.7)
0.051
0.088 10.22 16 (44.4) 14 (38.9) 6 (16.7)
0.007* 12.39 12 (31.6) 18 (47.4) 8 (21.1)
p Value
0.035* 12.66 11 (28.9) 16 (42.1) 11 (28.9)
0.035*
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PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
Table 4. Patients in ED categories at baseline, and 1, 4 and 12 weeks after biopsy ED Degree Biopsy alone: None Mild Mild-moderate Moderate Severe Biopsy ⫹ PPNB: None Mild Mild-moderate Moderate Severe Saturation biopsy: None Mild Mild-moderate Moderate Severe
No. Baseline (%)
No. Wk 1 (%)
p Value
No. Wk 4 (%)
p Value
No. Wk 12 (%)
p Value
13 (29.5) 10 (22,7) 6 (13.6) 3 (6.8) 12 (27.3)
6 (13.6) 9 (20.5) 5 (11.4) 1 (2.3) 23 (52.3)
0.119 1 1 0.616 0.028*
6 (13.6) 9 (20.5) 5 (11.4) 6 (13.6) 18 (40.9)
0.119 1 1 0.484 0.261
10 (22.7) 13 (29.5) 3 (6.8) 3 (6.8) 15 (34.1)
0.628 0.628 0.484 1 0.644
13 (36.1) 12 (33.3) 7 (19.4) 0 4 (11.2)
5 (13.9) 8 (22.2) 6 (16.7) 3 (8.3) 14 (38.9)
0.055 0.430 0.771 0.120 0.013*
12 (33.3) 7 (19.4) 7 (19.4) 1 (2.8) 9 (25.1)
0.811 0.285 1 1 0.220
13 (36.1) 6 (16.7) 8 (22.2) 2 (5.6) 7 (19.4)
1 0.173 1 0.493 0.515
13 (34.2) 5 (13.2) 4 (10.5) 7 (18.4) 9 (23.7)
7 (18.4) 3 (7.9) 2 (5.3) 6 (15.8) 20 (52.6)
0.192 0.711 0.675 0.772 0.018*
14 (36.8) 4 (10.5) 5 (13.2) 2 (5.3) 13 (34.2)
1 1 1 0.091 0.449
13 (34.2) 6 (15.8) 1 (2.6) 5 (13.2) 13 (24.2)
1 1 0.358 0.550 0.449
* Significant (p ⱕ0.05).
severe ED, and pain (univariate and multivariate p ⫽ 0.021 and 0.037, respectively). Any decrease in erectile function after 1 week also correlated with pain on univariate analysis (p ⫽ 0.034).
DISCUSSION Most studies of peri-interventional complications associated with prostate biopsy have focused on pain, hematuria and prostatitis.19,20 There are few publications of impaired voiding function and QOL aspects, eg erectile function.21 We found a significant increase in mean I-PSS in groups 1 to 3 (1.64, 2.19 and 1.31, respectively) 1 week after prostate biopsy. This resolved within the following 12 weeks in patients with 10-core biopsy with and without PPNB but not in those with saturation biopsy. We also found a transient decrease in IIEF-5 scores in groups 1 to 3 (⫺4.18, ⫺3.27 and ⫺1.14, respectively). Four weeks after prostate biopsy we noted a significant decrease in patients with 10-core biopsy with and without PPNB, which resolved after 3 months. We found no evidence of a persistent influence of certain factors, including local anesthesia, number of cores or age, on erectile function in any group but there was an association of transient ED with pain. In 2001 Zisman et al first described in detail the influence of prostate biopsy on patient general wellbeing, considering pain, voiding and erectile function.15,21 They delivered topical anesthesia with 2% lidocaine gel transrectally before prostate biopsy but did not use PPNB. They concluded that prostate biopsy has a measurable impact on voiding function. The larger the transition zone, the more likely prostate biopsy is to be associated with subjective symp-
toms and urinary retention. Thus, they recommended that patients with baseline I-PSS greater than 20 and transition zone volume greater than 42 ml be informed about the increased risk of impaired voiding. We could not substantiate this observation since we detected no correlation between increased I-PSS and prostate volume. In the series by Zisman et al 11 of 167 patients (7%) reported de novo ED when they were informed about the need for prostate biopsy and the problem persisted in 4.21 After biopsy some patients reported transient ED. Those with persistent ED had a higher anxiety. To our knowledge whether local damage to the neurovascular bundle or a psychological impact was responsible for ED remains an open question. Although our patients were not explicitly interviewed about anxiety, 5 reported severe anxiety about harboring CaP during the 3 to 5-day interval waiting for the final histopathological biopsy results. Libido was decreased during week 1, as substantiated by decreased median IIEF-5 and increased VAS scores. Thus, the psychological impact of an imminent cancer diagnosis and the pain experienced during biopsy seem to have an important role in transient ED after prostate biopsy. Bozlu et al noted transiently impaired voiding function until post-prostate biopsy day 30.16 Thus, they suggested medication with tamsulosin before and for a brief time after biopsy. All 66 patients underwent 12-core prostate biopsy with PPNB. The impact of the number of cores and PPNB on voiding function was not evaluated but QOL was altered by voiding symptoms. Significant impairment, as in our series, was not observed.
PROSTATE BIOPSY AND NERVE BLOCK IMPACT ON ERECTILE AND VOIDING FUNCTION
In 2006 Chrisofos et al reported ED after prostate biopsy.22 At biopsy 10 ml 2% lidocaine gel topical anesthesia were applied transrectally but PPNB was not used. No significant difference in erectile function was found 4 and 12 weeks after biopsy. Of previously potent men 9% reported persistent ED 3 months after biopsy. In our study population an additional 10 men (10.75%) complained about severe ED 3 months after biopsy. However, the difference was not significant on subgroup analysis. Patients with severe ED after biopsy had already had mild to moderate ED before biopsy. Thus, we advocate that patients with preexisting ED must be informed about the risk of worsening ED. Akbal et al performed saturation prostate biopsy in 150 patients.14 Median IIEF score was unchanged in 88 CaP-free patients followed for 6 months. However, 1 month after prostate biopsy 36 of 74 patients with no or mild ED before prostate biopsy had progressed to mild or moderate ED (p ⫽ 0.01). This difference resolved after 6 months. Notable saturation biopsy was done using general anesthesia in all throughout the study. Similar to our findings, there was no correlation between transient ED, age or number of biopsy cores but there was transiently impaired erectile function. Only Tuncel et al found a significant difference between prebiopsy and 6-month post-biopsy IIEF-5 scores.23 They also evaluated the impact on female sexual function and detected a significant impact even after 6 months. To our knowledge our study is the first to evaluate the impact of the number of biopsy cores and PPNB on voiding function and potency. Erectile function is not significantly influenced by these factors and biopsy can be done with low risk. In addition to previous studies, we noted that impaired QOL due to urinary symptoms seems to be associated with an
1451
increased number of biopsy cores and with PPNB. We found a measurable yet transient impact on voiding and erectile function in patients with 10core prostate biopsy with and without PPNB, which was more pronounced and durable after saturation prostate biopsy with PPNB. Regarding underlying pathophysiology, our data show that any additional measure over the standard prostate biopsy regimen (10 vs 20 cores and PPNB vs no PPNB) causes impaired voiding until week 1, which persists in patients with 20-core prostate biopsy and PPNB. Thus, we propose that increasing the number of biopsy cores and PPNB irritate the neurovascular bundle, resulting in impaired voiding and erectile function. Our assumption is indirectly supported by the fact that, in addition to preventing erection loss, preserving the neurovascular bundle at radical prostatectomy positively influences early postoperative continence.24,25
CONCLUSIONS Transrectal ultrasound guided prostate biopsy is well tolerated, especially when combined with local anesthesia. However, PPNB causes voiding problems, which resolve 1 to 4 weeks after prostate biopsy. Erectile function is transiently impaired after prostate biopsy regardless of PPNB and the number of cores. Impairment is reversible within 3 months. PPNB does not cause permanent damage to the neurovascular bundle. Patient age, the number of cores and local anesthesia have no lasting impact on erectile function but further evaluation is needed to evaluate the psychological influence on erectile function. Before prostate biopsy patients should be informed about a transient detriment in erectile function and worsening preexisting ED. Those who undergo saturation prostate biopsy must be informed about the risk of prolonged difficult voiding.
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