Dataset Information

'Pain-free TRUS B': a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501).

ABSTRACT:

Objective

To determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience.

Patients and methods

We conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events.

Results

The mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events.

Conclusions

We found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

SUBMITTER: Hayne D

PROVIDER: S-EPMC9291594 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:The Korean Society of Urogenital Radiology (KSUR) aimed to present a consensus statement for patient preparation, standard technique, and pain management in relation to transrectal ultrasound-guided prostate biopsy (TRUS-Bx) to reduce the variability in TRUS-Bx methodologies and suggest a nationwide guideline. The KSUR guideline development subcommittee constructed questionnaires assessing prebiopsy anticoagulation, the cleansing enema, antimicrobial prophylaxis, local anesthesia methods such as periprostatic neurovascular bundle block (PNB) or intrarectal lidocaine gel application (IRLA), opioid usage, and the number of biopsy cores and length and diameter of the biopsy needle. The survey was conducted using an Internet-based platform, and responses were solicited from the 90 members registered on the KSUR mailing list as of 2018. A comprehensive search of relevant literature from Medline database was conducted. The strength of each recommendation was graded on the basis of the level of evidence. Among the 90 registered members, 29 doctors (32.2%) responded to this online survey. Most KSUR members stopped anticoagulants (100%) and antiplatelets (76%) one week before the procedure. All respondents performed a cleansing enema before TRUS-Bx. Approximately 86% of respondents administered prophylactic antibiotics before TRUS-Bx. The most frequently used antibiotics were third-generation cephalosporins. PNB was the most widely used pain control method, followed by a combination of PNB plus IRLA. Opioids were rarely used (6.8%), and they were used only as an adjunctive pain management approach during TRUS-Bx. The KSUR members mainly chose the 12-core biopsy method (89.7%) and 18G 16-mm or 22-mm (96.5%) needles. The KSUR recommends the 12-core biopsy scheme with PNB with or without IRLA as the standard protocol for TRUS-Bx. Anticoagulants and antiplatelet agents should be discontinued at least 5 days prior to the procedure, and antibiotic prophylaxis is highly recommended to prevent infectious complications. Glycerin cleansing enemas and administration of opioid analogues before the procedure could be helpful in some situations. The choice of biopsy needle is dependent on the practitioners' situation and preferences.

Project description:ImportanceMagnetic resonance imaging (MRI) with targeted biopsy is an appealing alternative to systematic 12-core transrectal ultrasonography (TRUS) biopsy for prostate cancer diagnosis, but has yet to be widely adopted.ObjectiveTo determine whether MRI with only targeted biopsy was noninferior to systematic TRUS biopsies in the detection of International Society of Urological Pathology grade group (GG) 2 or greater prostate cancer.Design, setting, and participantsThis multicenter, prospective randomized clinical trial was conducted in 5 Canadian academic health sciences centers between January 2017 and November 2019, and data were analyzed between January and March 2020. Participants included biopsy-naive men with a clinical suspicion of prostate cancer who were advised to undergo a prostate biopsy. Clinical suspicion was defined as a 5% or greater chance of GG2 or greater prostate cancer using the Prostate Cancer Prevention Trial Risk Calculator, version 2. Additional criteria were serum prostate-specific antigen levels of 20 ng/mL or less (to convert to micrograms per liter, multiply by 1) and no contraindication to MRI.InterventionsMagnetic resonance imaging-targeted biopsy (MRI-TB) only if a lesion with a Prostate Imaging Reporting and Data System (PI-RADS), v 2.0, score of 3 or greater was identified vs 12-core systematic TRUS biopsy.Main outcome and measuresThe proportion of men with a diagnosis of GG2 or greater cancer. Secondary outcomes included the proportion who received a diagnosis of GG1 prostate cancer; GG3 or greater cancer; no significant cancer but subsequent positive MRI results and/or GG2 or greater cancer detected on a repeated biopsy by 2 years; and adverse events.ResultsThe intention-to-treat population comprised 453 patients (367 [81.0%] White, 19 [4.2%] African Canadian, 32 [7.1%] Asian, and 10 [2.2%] Hispanic) who were randomized to undergo TRUS biopsy (226 [49.9%]) or MRI-TB (227 [51.1%]), of which 421 (93.0%) were evaluable per protocol. A lesion with a PI-RADS score of 3 or greater was detected in 138 of 221 men (62.4%) who underwent MRI, with 26 (12.1%), 82 (38.1%), and 30 (14.0%) having maximum PI-RADS scores of 3, 4, and 5, respectively. Eighty-three of 221 men who underwent MRI-TB (37%) had a negative MRI result and avoided biopsy. Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, -3.4% to ∞; noninferiority margin, -5%). Adverse events were less common in the MRI-TB arm. Grade group 1 cancer detection was reduced by more than half in the MRI arm (from 22% to 10%; risk difference, -11.6%; 95% CI, -18.2% to -4.9%).Conclusions and relevanceMagnetic resonance imaging followed by selected targeted biopsy is noninferior to initial systematic biopsy in men at risk for prostate cancer in detecting GG2 or greater cancers.Trial registrationClinicalTrials.gov Identifier: NCT02936258.