Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate: The UNBLOCS RCT and economic evaluation

Worthington, J; Lane, JA; Taylor, H; Young, G; Noble, SM; Abrams, P; Ahern, A; Brookes, ST; Cotterill, N; Johnson, L; Khan, R; Fernandez, AM; Page, T; Swami, S; Hashim, H

Abstract

Background: Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a technique similar to TURP. The small amount of existing literature suggested potential advantages over TURP.

Objective(s): To determine whether ThuVARP is equivalent to TURP in men with BPO treated within the NHS.

Design: A multi-centre, pragmatic, randomised, controlled, parallel-group trial, with embedded qualitative study and economic evaluation.

Setting: Seven UK centres: four university teaching hospitals and three district general hospitals.

Participants: Men ≥ 18 years suitable for TURP, presenting with bothersome Lower Urinary Tract Symptoms (LUTS) or urinary retention secondary to BPO.

Interventions: Patients were randomised 1:1 to receive TURP or ThuVARP and remained blinded.

Main outcome measures: Two co-primary outcomes; patient reported International Prostate Symptom Score (IPSS), and clinical measure of maximum urine flow rate (Qmax) 12 months post-surgery.

Results: In total, 410 men were randomised, 205 per arm. The two procedures were equivalent for IPSS score [adjusted mean difference 0.28 points higher in ThuVARP (favouring TURP), 95% confidence interval (CI) -0.92 to 1.49]. The two procedures were not equivalent for Qmax [adjusted mean difference of 3.12ml/s in favour of TURP, 95% CI 0.45 to 5.79ml/s], with TURP deemed to be superior to ThuVARP. Surgical outcomes such as complication and blood transfusion rates, and hospital stay were similar for ThuVARP and TURP. Patient reported urinary and sexual symptoms were also similar between the arms. Qualitative interviews indicated similar patient experiences for both procedures. However, 25% of ThuVARP patients did not undergo their randomised allocation versus 2% for TURP. Prostate cancer was also detected less frequently from routine histology after ThuVARP [65% lower odds of detection], in an exploratory analysis. Adjusted mean differences between the arms were similar for secondary care NHS costs (£71 higher in ThuVARP, 95% CI -£343 to £486) and Quality Adjusted Life Years (QALYs) (0.01 favouring TURP, 95% CI -0.04 to 0.02).

Limitations: Complications were collected in pre-specified categories; those not pre-specified were excluded due to variable reporting. Pre-operative Qmax and IPSS data could not be collected for patients with indwelling catheters, making adjustment for baseline status difficult.

Conclusions: TURP was superior to ThuVARP for Qmax, although both operations achieved a Qmax considered clinically successful. ThuVARP also potentially resulted in lower detection of prostate cancer due to a lesser volume of tissue for histology. Length of hospital stay, anticipated to be a key benefit for ThuVARP, was equal to TURP in this trial. Overall, both ThuVARP and TURP were effective procedures for BPO, with minor benefits favouring TURP. The results therefore suggest that it may be appropriate that new treatment alternatives continue to be compared to TURP.

Future work: Longer-term follow up to assess reoperation rates over time, and research into the comparative effectiveness of ThuVARP and TURP in large prostates.

Trial registration: ISRCTN registry - ISRCTN00788389

Funding: National Institute for Health and Research, Health Technology Assessment (HTA) programme.

• Report Type: Project Report
• Acceptance Date: Feb 26, 2019
• Deposit Date: Mar 7, 2019
• Peer Reviewed: Peer Reviewed
• Keywords: benign prostatic obstruction, laser therapy, lower urinary tract symptoms, randomised controlled trial, qualitative, ThuVARP, TURP, patient experience, quality of life, satisfaction.
• Public URL: https://uwe-repository.worktribe.com/output/851776
• Contract Date: Mar 7, 2019