Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained

Peter Gilling, Neil Barber, Mohamed Bidair, Paul Anderson, Mark Sutton, Tev Aho, Eugene Kramolowsky, Andrew Thomas, Barrett Cowan, Ronald P Kaufman Jr, Andrew Trainer, Andrew Arther, Gopal Badlani, Mark Plante, Mihir Desai, Leo Doumanian, Alexis E Te, Mark DeGuenther, Claus Roehrborn, Peter Gilling, Neil Barber, Mohamed Bidair, Paul Anderson, Mark Sutton, Tev Aho, Eugene Kramolowsky, Andrew Thomas, Barrett Cowan, Ronald P Kaufman Jr, Andrew Trainer, Andrew Arther, Gopal Badlani, Mark Plante, Mihir Desai, Leo Doumanian, Alexis E Te, Mark DeGuenther, Claus Roehrborn

Abstract

Introduction: To compare 2-year safety and efficacy outcomes after Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH).

Methods: One hundred eighty-one patients with BPH were assigned at random (2:1 ratio) to either Aquablation or TURP. Patients and follow-up assessors were blinded to treatment. Assessments included the International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function and uroflow. The focus of analysis was 2-year outcomes.

Results: At 2 years, IPSS scores improved by 14.7 points in the Aquablation group and 14.9 points in TURP (p = .8304, 95% CI for difference - 2.1 to 2.6 points). Two-year improvements in maximum flow rate (Qmax) were large in both groups at 11.2 and 8.6 cc/s for Aquablation and TURP, respectively (p = 0.1880, 95% CI for difference - 1.3 to 6.4). Sexual function as assessed by MSHQ was stable in the Aquablation group and decreased slightly in the TURP group. At 2 years, PSA was reduced significantly in both groups by 0.7 and 1.2 points, respectively; the reduction was similar across groups (p = 0.1816). Surgical retreatment rates after 12 months for Aquablation were 1.7% and 0% for TURP. Over 2 years, surgical BPH retreatment rates were 4.3% and 1.5% (p = 0.4219), respectively.

Conclusion: Two-year efficacy outcomes after TURP and Aquablation were similar, and the rate of surgical retreatment was low and similar to TURP.

Trial registration: ClinicalTrials.gov no. NCT02505919.

Funding: PROCEPT BioRobotics.

Keywords: Aquablation; BPH; Robotic surgery; TURP; Urology.

Figures

Fig. 1
Fig. 1
CONSORT diagram. Asterisk: one subject exited early because of prostate cancer. Double asterisk: two subjects exited early because of subject expiration prior to the 24-month visit
Fig. 2
Fig. 2
Change in International Prostate Symptom Score (IPSS, top left), IPSS quality of life (top right), and IPSS voiding (bottom left) and storage (bottom right) scores. Circles: Aquablation; triangles: TURP
Fig. 3
Fig. 3
Uroflow measures by treatment and time. For PVR, inset graph shows subgroup analysis of those with elevated (> 100 cc) and not elevated (

Fig. 4

Change in total MSHQ (top)…

Fig. 4

Change in total MSHQ (top) and MSHQ bother (bottom) by treatment and time.…

Fig. 4
Change in total MSHQ (top) and MSHQ bother (bottom) by treatment and time. Circles: Aquablation; triangles: TURP. Numbers next to graph are p values for one-way change from 0. Numbers at bottom of graph are effect size (difference, Aquablation—TURP) and t test p value for difference

Fig. 5

Change in International Index of…

Fig. 5

Change in International Index of Erectile Function subdomains by treatment and time. Circles:…

Fig. 5
Change in International Index of Erectile Function subdomains by treatment and time. Circles: Aquablation; triangles: TURP
Fig. 4
Fig. 4
Change in total MSHQ (top) and MSHQ bother (bottom) by treatment and time. Circles: Aquablation; triangles: TURP. Numbers next to graph are p values for one-way change from 0. Numbers at bottom of graph are effect size (difference, Aquablation—TURP) and t test p value for difference
Fig. 5
Fig. 5
Change in International Index of Erectile Function subdomains by treatment and time. Circles: Aquablation; triangles: TURP

References

    1. Trueman P, Hood SC, Nayak US, et al. Prevalence of lower urinary tract symptoms and self-reported diagnosed “benign prostatic hyperplasia”, and their effect on quality of life in a community-based survey of men in the UK. BJU Int. 1999;83:410–415. doi: 10.1046/j.1464-410x.1999.00966.x.
    1. Naslund MJ, Gilsenan AW, Midkiff KD, et al. Prevalence of lower urinary tract symptoms and prostate enlargement in the primary care setting. Int J Clin Pract. 2007;61:1437–1445. doi: 10.1111/j.1742-1241.2007.01508.x.
    1. Madersbacher S, Marberger M. Is transurethral resection of the prostate still justified? BJU Int. 1999;83:227–237. doi: 10.1046/j.1464-410x.1999.00908.x.
    1. McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011;185:1793–1803. doi: 10.1016/j.juro.2011.01.074.
    1. Miano R, De Nunzio C, Asimakopoulos AD, et al. Treatment options for benign prostatic hyperplasia in older men. Med Sci Monit Int Med J Exp Clin Res. 2008;14:RA94–R102.
    1. Rassweiler J, Teber D, Kuntz R, et al. Complications of transurethral resection of the prostate (TURP)—incidence, management, and prevention. Eur Urol. 2006;50:969–979. doi: 10.1016/j.eururo.2005.12.042.
    1. Montorsi F, Moncada I. Safety and tolerability of treatment for BPH. Eur Urol Suppl. 2006;5:1004–1012. doi: 10.1016/j.eursup.2006.08.012.
    1. Emberton M, Neal DE, Black N, et al. The effect of prostatectomy on symptom severity and quality of life. Br J Urol. 1996;77:233–247. doi: 10.1046/j.1464-410X.1996.88213.x.
    1. Gilling P, Barber N, Bidair M, et al. WATER: a double-blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol. 2018;199:1252–1261. doi: 10.1016/j.juro.2017.12.065.
    1. Barry MJ, Fowler FJ, O’Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992;148:1549–1557. doi: 10.1016/S0022-5347(17)36966-5.
    1. Gilling P, Reuther R, Kahokehr A, et al. Aquablation—image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU Int. 2016;117:923–929. doi: 10.1111/bju.13358.
    1. Aljuri N, Gilling P, Roehrborn C. How I do it: balloon tamponade of prostatic fossa following Aquablation. Can J Urol. 2017;24:8937–8940.
    1. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–213. doi: 10.1097/.
    1. Li S, Zeng X-T, Ruan X-L, et al. Holmium laser enucleation versus transurethral resection in patients with benign prostate hyperplasia: an updated systematic review with meta-analysis and trial sequential analysis. PLoS One. 2014;9:e101615. doi: 10.1371/journal.pone.0101615.
    1. Bachmann A, Tubaro A, Barber N, et al. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial–the GOLIATH study. Eur Urol. 2014;65:931–942. doi: 10.1016/j.eururo.2013.10.040.
    1. McVary KT, Roehrborn CG. Three-year outcomes of the prospective, randomized controlled Rezūm system study: convective radiofrequency thermal for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Urology. 2018;111:1–9. doi: 10.1016/j.urology.2017.10.023.
    1. Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. study. J Urol. 2013;190:2161–2167. doi: 10.1016/j.juro.2013.05.116.
    1. Chughtai B, Thomas D. Pooled aquablation results for american men with lower urinary tract symptoms due to benign prostatic hyperplasia in large prostates (60–150 cc) Adv Ther. 2018;35:832–838. doi: 10.1007/s12325-018-0722-0.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner