Introduction

Transrectal ultrasound-guided biopsies of the prostate have become an integral part of the diagnostic methodology used for patients with an abnormal digital rectal examination or elevated prostate-specific antigen (PSA). Although, transrectal ultrasound-guided biopsies are reasonably well tolerated in most patients, they could be partly associated with some discomfort. During transrectal prostate biopsy, the role of anesthesia on pain and tolerance is controversial.^1,2,3,4 Four studies, of which three were prospective and randomized, demonstrated a benefit for pain with local anesthesia.^1,2,3,5 However, a prospective randomized study showed no statistically significant difference on pain between local anesthesia and no anesthesia.⁴ The objectives of our study were to evaluate pain and tolerance of transrectal ultrasound-guided biopsy of the prostate without any anesthesia and to identify a correlation between pain and six parameters: patient age, prostate volume, cores number, operator, previous biopsy and first core location (apex or base).

Materials and methods

Prospectively, we enrolled 131 consecutive men who underwent transrectal ultrasound-guided biopsies of the prostate without any anesthesia or sedation. Indications for prostate biopsy were abnormal digital rectal examination (n=28) and/or >4 ng/ml serum PSA (n=103). Mean age of patients was 667.7 y (range: 42–81). Mean prostate volume on transrectal prostate ultrasonography was 4212 cm³ (range: 10–94). Mean serum PSA was 13.324 ml (range: 0.4–192). The median number of cores was 7 (range: 4–10). The distribution of cores number per patient is summarized in Table 1. The location of the first core was the apex for 43 patients and the base for 88 patients, depending on the operator. Four experienced senior urologists performed biopsy. It was the first prostate biopsy for 99 patients (75%).

Table 1 - Number of cores per patient.

Full table

All patients received 2 h before biopsy an oral fluoroquinolone prophylaxis or appropriate alternative antibiotic in the case of fluoroquinolone allergy. A cleansing enema was administered on the evening before and on the morning of biopsy. Patients were placed in the left lateral decubitus position. The biopsy was performed in an outpatient setting. Informed consent was obtained from all study participants. Patients were not informed of study before the biopsy. An anonymous questionnaire was given immediately after biopsy. All 131 consecutive patients agreed to fill the questionnaire (Figure 1). Subjective evaluation of the pain was assessed by the patient after biopsy using a quantitative pain scale (0: no pain–10: intolerable pain) and a semiquantitative pain scale (zero, low, median, strong, very strong). Objective evaluation of the pain was assessed by the operator after biopsy using a 10-point linear visual analogue pain scale (visual analog scale (VAS); 0: no pain – 10: intolerable pain). We used Excel software 97 for basic data. Univariate and multivariate statistical analyses were performed to identify a significant correlation between pain and parameters (P0.05).

Figure 1.

Questionnaire used to assess pain and discomfort immediately after prostatic biopsy.

Full figure and legend (37K)

We used Student's t-test for continuous variables, ² test for qualitative variables, and the Kruskal–Wallis test for matching ones.

For multivariate analysis, ANOVA regression analysis was used and SPSS software was employed for the analysis.

Results

Final histological results revealed normal prostate in 68 men (52%), prostate cancer in 45 men (34%), prostatitis in 14 men (11%) and prostatic intraepithelial neoplasia in four men (3%). The subjective median score of pain was 5 and 58 patients (44%) had a pain score of less than 5. The objective median score of pain was 5 and 60 patients (46%) had a pain score of less than 5. There was no significant statistical difference between subjective and objective pain (data not shown). In all, 10 patients reported no pain during the biopsy (7.5%). Pain was subjectively low for 32 patients (24.5%), medium for 63 patients (48%), high for 16 patients (12.5%) and very high for 10 patients (7.5%).

Pain had no influence on the biopsy procedure for 101 patients (77%). Owing to the pain intensity, a break was necessary for 25 patients (19%) and biopsy was stopped for five patients (4%).

Most of the patients (81%) considered that no drug or anesthesia would be necessary. In total, 10 patients (7.5%) would have liked an analgesic drug. Eight patients (6%) would have liked a drug for anxiety and seven patients (5.5%) would have liked a local or general anesthesia. In all, 85% of patients would agree to undergo another biopsy under the same conditions. There was no major complication (no patient required hospital admission).

Univariate analysis is summarized in Table 2. It shows a statistically significant difference of the objective pain score for the first core location only (apex score: 5.22.3–base score: 4.32.2, P=0.02). The other parameters (previous biopsy, cores number, age, prostate volume, operator) had no statistically significant influence on objective pain score. Multivariate analysis is summarized in Table 3.

Table 2 - Univariate analysis.

Full table

Table 3 - Multivariate analysis.

Full table

In multivariate analysis, only the first core location had statistical influence on the objective pain score. Apex biopsy first was more painful than base biopsy first (Table 3).

Discussion

Standard sextant transrectal ultrasound-guided biopsy of prostate is an accepted technique for prostate cancer diagnosis. Usually, the discomfort associated with biopsy is perceived by the urologists as being mild or insignificant. Several authors have reported that biopsy can be routinely performed without anesthesia or sedation.^6,7,8 In our study, 80% of the patients reported an acceptable discomfort (no, low or medium pain). This percentage is similar to previous reported percentages.^6,8,9,10,11 However, it is difficult to compare the results, because most authors did not use a 10-point linear visual analog pain scale to quantify the pain objectively. The scales of subjective pain used in other series were different from ours. Assessment of pain is subjective and varies according to the authors. For Deliveliotis, prostate biopsy is a well-tolerated method with 25% of patients complaining of moderate or severe pain.⁸ While for Crundwell, prostate biopsy is often a painful experience with 24% of patients complaining of moderate or severe discomfort.⁹

Identification of risk factors for pain may be important for selecting a subgroup of patients who may benefit from anesthesia or drugs. In the literature, few studies reported risk factors of pain.^6,12

In our study, cores number had no influence on pain. The study by Rodriguez confirmed this result.⁶ For Naughton, the effect on pain of increasing the number of cores from 6 to 12 was not significantly associated with the discomfort.¹²

Our results showed that biopsy discomfort was not significantly correlated with prostate volume. These findings were corroborated by the study of Rodriguez.⁶

Our study showed no significant difference in pain according to age. However, Rodriguez reported a greater pain in younger patients (under 70 y).⁶ Rodriguez's subjective pain scale was different with respect to ours and the median age of his patients was greater than that of ours (70 vs 66).

In our experience, operator and previous biopsy had no influence on pain. In the literature, no study has investigated these parameters as risk factors of pain.

In our series, first core location was the only factor that influenced pain. However, for Rodriguez et al⁶ biopsy location had no influence on the latter. However, they did not state where the first core was located.

The degree of patient acceptance is hard to quantify. However, in our study, 85% of patients would agree to undergo another biopsy under the same conditions. Only 5.5% of patients would like an anesthesia. For the same questions, Irani et al¹³ reported 81 and 6%, respectively.¹³

Several authors reported a benefit on pain and tolerance during transrectal ultrasonography-guided prostate biopsy with periprostatic local anesthesia.^2,5 This approach seems very interesting for some of the patients. However, in these studies the research of risk factors of pain has not been assessed.

In summary, among the parameters we studied, only first core location seems to influence pain but it does not allow selection of a subgroup that would benefit from anesthesia.

Conclusions

Transrectal ultrasound-guided prostatic biopsy performed without anesthesia is a method well tolerated by most of patients. In our study, only the first core location influenced pain and we recommend starting biopsy with the base.

References

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