Patients with frailty, benign prostatic hyperplasia and indwelling bladder catheter: What are the 1-year outcomes after Rezūm therapy?

Abstract

Background: Rezūm therapy, a minimally invasive surgical procedure for benign prostatic hyperplasia (BPH), was very recently developed. Its characteristics and safety profile render its use in patients with multiple comorbidities attractive. In this study, we evaluated the outcomes of Rezūm therapy in patients with frailty, BPH, and an indwelling catheter.

Methods: This single-center prospective study involved consecutive patients with frailty who underwent Rezūm therapy from June 2022 to December 2023. Patients with a prostate volume of 30-150 cm³, indwelling bladder catheter for ≥6 months, and diagnosis of frailty were included. Frailty was defined as the concomitant presence of a Clinical Frailty Score of ≥4, Charlson Comorbidity Index of ≥3, and Modified Frailty Index of ≥2. The primary end point was successful removal of the catheter and continued catheter independence 12 months after treatment. The International Prostate Symptom Score, maximum urinary flow rate, and post-void residual volume were evaluated 3, 6, and 12 months after the procedure. Adverse events were monitored throughout the study.

Results: Seventy patients were included: catheter removal was successful in 66 of these patients (94%), all of whom completed 1 year of follow-up without recatheterization. Statistically significant (p < 0.05) improvement was observed in the International Prostate Symptom Score, maximum urinary flow rate, and post-void residual volume during follow-up. No intraprocedural complications occurred. At 30 days, 4 of the 66 patients (6%) experienced postprocedural complications of Clavien-Dindo grades II (n = 2) and IIIa (n = 1).

Conclusions: Rezūm therapy was effectively and safely performed in patients with frailty, BPH, and an indwelling catheter. Further large comparative studies are needed.

Keywords

Benign prostatic hyperplasia / Catheter / Frailty / Rezūm therapy / Water vapor

Acknowledgments

We acknowledge Dr. M. Campanaro for her invaluable assistance in revising the manuscript.

Statement of ethics

This study was conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects. The study protocol was approved by the Institutional Review Board of University of Campania “Luigi Vanvitelli” - AOU Luigi Vanvitelli - AORN “Ospedali dei Colli” (approval number 11566/2022). All patients provided written informed consent for the inclusion of their data in the database and the use of these data in scientific research.

Conflicts of interest statement

All authors have completed the ICMJE uniform disclosure form. The authors have no conflicts of interest to declare.

Funding source

None.

Author contributions

ST, RB: Conception and design;

MDS, FF, FU, FC, MF: Administrative support;

RB, FU, DA: Provision of study materials or patients;

ST, BB, CM, LS: Collection and assembly of data;

BB, CM, ST: Data analysis and interpretation;

All authors: Manuscript writing and final approval of manuscript.

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

[1] Cherubini A, Del Signore S, Ouslander J, Semla T, Michel JP. Fighting against age discrimination in clinical trials. J Am Geriatr Soc 2010; 58(9):1791-1796.

[2] Morley JE, Vellas B, Abellan van Kan G, et al. Frailty consensus: A call to action. J Am Med Dir Assoc 2013; 14(6):392-397.

[3] Theou O, Walston J, Rockwood K. Operationalizing frailty using the frailty phenotype and deficit accumulation approaches. Interdiscip Top Gerontol Geriatr 2015;41:66-73.

[4] Gobbens RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. In search of an integral conceptual definition of frailty: Opinions of experts. J Am Med Dir Assoc 2010; 11(5):338-343.

[5] Roehrborn CG. The epidemiology of acute urinary retention in benign prostatic hyperplasia. Rev Urol 2001; 3(4):187-192.

[6] Fitzpatrick JM, Desgrandchamps F, Adjali K, et al. Management of acute urinary retention: A worldwide survey of 6074 men with benign prostatic hyperplasia. BJU Int 2012; 109(1):88-95.

[7] Licari LC, Bologna E, Manfredi C, et al. Incidence and management of BPH surgery-related urethral stricture: Results from a large U.S. database. Prostate Cancer Prostatic Dis 2024; 27(3):537-543.

[8] Crocerossa F, Cantiello F, Bagalá L, et al. Clinical effects of oral supplementation of gamma-cyclodextrin curcumin complex in male patients with moderate-to-severe benign prostatic hyperplasia-related lower urinary tract symptoms. Urol Int 2023; 107(10-12):924-934.

[9] Ditonno F, Manfredi C, Licari LC, et al. Benign prostatic hyperplasia surgery: A snapshot of trends, costs, and surgical retreatment rates in the USA. Eur Urol Focus 2024; 10(5):826-832.

[10] Spirito L, Capra M, Sciorio C, et al. Long-term functional outcomes and predictors of efficacy in thulium laser enucleation of the prostate (ThuLEP) for benign prostatic hyperplasia (BPH): A retrospective observational study. J Basic Clin Physiol Pharmacol 2024; 35(3):169-174.

[11] Gondran-Tellier B, McManus R, Sichez PC, et al. Efficacy and safety of surgery for benign prostatic obstruction in patients with preoperative urinary catheter. J Endourol 2021; 35(1):102-108.

[12] Bologna E, Licari LC, Franco A, et al. Incidental prostate cancer in patients treated for benign prostatic hyperplasia: Analysis from a contemporary national dataset. Diagnostics (Basel) 2024; 14(7):677.

[13] Creta M, Manfredi C, Arcaniolo D, et al. Mobile health: A promising tool for the management of male patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 2023; 26(4):712-714.

[14] Pandolfo SD, Del Giudice F, Chung BI, et al. Robotic assisted simple prostatectomy versus other treatment modalities for large benign prostatic hyperplasia: A systematic review and meta-analysis of over 6500 cases. Prostate Cancer Prostatic Dis 2023; 26(3):495-510.

[15] Cindolo L, Morselli S, Campobasso D, et al. One-year outcomes after water vapor thermal therapy for symptomatic benign prostatic hyperplasia in an unselected Italian multicenter cohort. Minerva Urol Nephrol 2023; 75(2):203-209.

[16] Kidd EA, Stewart F, Kassis NC, et al. Urethral (indwelling or intermittent) or suprapubic routes for short-term catheterisation in hospitalised adults. Cochrane Database Syst Rev 2015; 2015(12):CD004203.

[17] Spinos T, Katafigiotis I, Leotsakos I, et al. Rezūm water vapor therapy for the treatment of patients with urinary retention and permanent catheter dependence secondary to benign prostate hyperplasia: A systematic review of the literature. World J Urol 2023; 41(2):413-420.

[18] Balsamo R, Tammaro S, Trivellato M, et al. Water vapor thermal therapy (Rezūm system) in patients with large prostates: Results from a prospective comparative study. Minerva Urol Nephrol 2024; 76(6):759-767.

[19] Minore A, Morselli S, Franzoso F, et al. Is water vapor thermal therapy safe and feasible in elderly and frail men? The Italian experience. World J Urol 2024; 42(1):60.

[20] Siena G, Tellini R, Cindolo L. Can Rezum stand out as the most versatile and better performing minimally invasive treatment for the management of LUTS related to BPH? Minerva Urol Nephrol 2022; 74(5):499-501.

[21] Siena G, Cindolo L, Ferrari G, et al. Water vapor therapy (Rezūm) for lower urinary tract symptoms related to benign prostatic hyperplasia: Early results from the first Italian multicentric study. World J Urol 2021; 39(10):3875-3880.

[22] World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310(20):2191-2194.

[23] Takanashi M, Ito H, Fukazawa T, et al. Predictive factors for the success of trial without catheter for men with urinary retention. Low Urin Tract Symptoms 2023; 15(5):173-179.

[24] Goldwag J, Harris A, Bettis AD. 5-Item Modified Frailty Index as a preoperative predictor of morbidity following minimally invasive partial nephrectomy. Urology 2021;157:138-142.

[25] Chimukangara M, Helm MC, Frelich MJ, et al. A 5-item Frailty Index based on NSQIP data correlates with outcomes following paraesophageal hernia repair. Surg Endosc 2017;31:2509-2519.

[26] Subramaniam S, Aalberg JJ, Soriano RP, Divino CM. New 5-factor Modified Frailty Index using American College of Surgeons NSQIP data. J Am Coll Surg 2018; 226(2):173-181.e8.

[27] Cockett ATK, Ato Y, Chatelain C, et al. The International Consultation on Benign Prostatic Hyperplasia (BPH). Paris, France: World Health Organization; 1991.

[28] Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49(6):822-830.

[29] Viktrup L, Hayes RP, Wang P, Shen W. Construct validation of Patient Global Impression of Severity (PGI-S) and Improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol 2012;12:30.

[30] Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: Five-year experience. Ann Surg 2009; 250(2):187-196.

[31] Elterman D, Bhojani N, Vannabouathong C, et al. Rezūm therapy for ≥80-mL benign prostatic enlargement: A large, multicentre cohort study. BJU Int 2022; 130(4):522-527.

[32] Habibzadeh F. Data distribution: Normal or abnormal? J Korean Med Sci 2024; 39(3):e35.

[33] Li H, Johnson T. Wilcoxon's signed-rank statistic: What null hypothesis and why it matters. Pharm Stat 2014; 13(5):281-285.

[34] Manfredi C, García-Gómez B, Arcaniolo D, et al. Impact of surgery for benign prostatic hyperplasia on sexual function: A systematic review and meta-analysis of erectile function and ejaculatory function. Eur Urol Focus 2022; 8(6):1711-1732.

[35] Manfredi C, Napolitano L, Ditonno F, et al. Long-term functional outcomes and surgical retreatment after thulium laser enucleation of the prostate: A 10-year follow-up study. Int Braz J Urol 2024; 50(3):309-318.

[36] Manfredi C, Arcaniolo D, Spatafora P, et al. Emerging minimally invasive transurethral treatments for benign prostatic hyperplasia: A systematic review with meta-analysis of functional outcomes and description of complications. Minerva Urol Nephrol 2022; 74(4):389-399.

[37] McVary KT, Holland B, Beahrs JR. Water vapor thermal therapy to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 2020; 23(2):303-308.

[38] Wong A, Mahmalji W. The role of Rezūm™ team ablation of the prostate in the treatment of patients with acute urinary retention secondary to benign prostatic hyperplasia. A single center, single surgeon case series and literature review. Aging Male 2020; 23(5):1620-1626.

[39] Elterman DS, Bhojani N, Vannabouathong C, Chughtai B, Zorn KC. Rezūm water vapor therapy for catheter-dependent urinary retention: A real-world Canadian experience. Can J Urol 2022; 29(2):11075-11079.

[40] Khalil IA, Aldeeb M, Mohammed A, et al. The role of Rezum in the management of refractory urinary retention due to benign prostate hyperplasia: A literature review. Arab J Urol 2023; 21(3):185-189.

[41] Tammaro S, Arcaniolo D, Spirito L, et al. Top researchers in andrology: A bibliometric and demographic analysis of the last 7 years. J Mens Health 2024; 20(8):56-62.

[42] Eredics K, Wehrberger C, Henning A, et al. Rezūm water vapor therapy in multimorbid patients with urinary retention and catheter dependency. Prostate Cancer Prostatic Dis 2022; 25(2):302-305.

[43] Tadrist A, Baboudjian M, Bah MB, et al. Water vapor thermal therapy for indwelling urinary catheter removal in frail patients. Int Urol Nephrol 2023; 55(2):249-253.

[44] Mynderse LA, Hanson D, Robb RA, et al. Rezūm system water vapor treatment for lower urinary tract symptoms/benign prostatic hyperplasia: Validation of convective thermal energy transfer and characterization with magnetic resonance imaging and 3-dimensional renderings. Urology 2015; 86(1):122-127.

[45] Westwood J, Geraghty R, Jones P, Rai BP, Somani BK. Rezum: A new transurethral water vapour therapy for benign prostatic hyperplasia. Ther Adv Urol 2018; 10(11):327-333.