New minimally invasive techniques versus gold standard approach for middle volume prostates (30-80 ml): a multicentre prospective randomized study

Pastore A1, Al salhi Y1, Fuschi A1, Suraci P1, Scalzo S1, Rera O1, Sequi M1, Valenzi F1, De Nunzio C2, Carbone A1

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Best in Category Prize: Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction
Abstract 59
Male Lower Urinary Tract Symptoms
Scientific Podium Short Oral Session 7
Wednesday 23rd October 2024
14:00 - 14:07
Hall N105
Bladder Outlet Obstruction Benign Prostatic Hyperplasia (BPH) Clinical Trial Prospective Study New Devices
1. Sapienza University of Rome, Faculty of Pharmacy and Medicine, Dept. of Urology, ICOT, latina Italy, 2. Sapienza University of Rome, Faculty of Psychology and Medicine, Dept. of Urology,, Roma Italy
Presenter
Links

Abstract

Hypothesis / aims of study
Transurethral resection of prostate (TURP) is still considered the gold standard therapy for mid volume prostate glands (30-80 ml), as recommended by worldwide guidelines.
In the last few years, other minimally invasive tretaments have been introduced with the aim to reduce the TURP related morbidity, such as: convective water vapor energy (Rezum) and water-jet ablation (Aquablation).
The aim of this prospective randomized study is to compare the perioperative and functional outcomes between gold standard TURP and the two new minimally invasive techniques (Rezum and Aquablation).
Study design, materials and methods
Patients with non-neurogenic Lower Urinary Tract Symptoms (LUTS) secondary to mid volume benign prostatic obstruction (30-80 ml), non-responders to medical therapy for at least 6 months, were prospectively randomized to the three surgical approaches between January 2021 and July 2023. 
All patients were preoperatively evaluated with digital rectal examination (DRE), PSA, prostate volume was evaluated by trans abdominal ultrasound. Preoperatively, 6-, and 9-months postop all subjects were investigated with: Uroflowmetry (Qmax and Qave) with postvoid residual (PVR), International Prostatic Symptoms Score (IPSS), Male Sexual Health Questionnaire (MSHQ) and International Index of Erectile Function (IIEF-5). In all patients urodynamics was performed.
Exclusion criteria were established as: prostate volume <30 and >80 ml, previous pelvic surgery, urethral strictures, urothelial or prostatic malignancies, neurogenic LUTS, and urinary stones.
Operating time, days of hospitalization, intraoperative and postoperative bleeding, catheterization time were evaluated for each procedure.
Results
349 patients with mean age of 63.6 years old (56-74 years) were prospectively randomized to the following treatment groups: 112 subjects underwent Rezum (group A), 118 patients Aquablation (group B), and 119 patients bipolar TURP (group C). 
Postoperative IPSS resulted lower in patients underwent TURP and AQUABEAM (2 and 2, respectively) than Rezum (5; p<0.001). Both quality of life and sexual satisfaction evaluated through post-operative MSHQ reported a higher improvement after Rezum and Aquablation than after TURP.
Postoperative IIEF5 mean scores significantly increased in groups A and B (26 and 25, respectively) than in group C (17, p<0.001). The antegrade ejaculation was spared in all Rezum and Aquablation subjects, whereas all TURP patients reported retrograde ejaculation.

Operating time, length of hospital stay and bleeding drop were longer after TURP (respectively 56.9 min, 3 days) when compared to the other two groups (2.4 min, 0.6 days; 5.2 min, 1 day, in group A and B, respectively). The mean estimated blood loss (evaluated as postoperative drop in Hb) was significantly greater in group C (∆Hb 1.2 mg/dl) than in the other two groups (∆Hb 0.1 mg/dl observed in both groups, p <.005)
Postoperative bladder catheterization time was longer after Rezum (7 days) than after TURP (5 days) and Aquablation (1 day).
Interpretation of results
At post-operative urodynamics we observed a significant increase of flowmetry parameters (Qmax and Qave) as well as the Pdet values in all subjects. Particularly, the TURP group reported mean flowmetry parameters significantly better when compared to Aquabeam and Rezum groups (mean Qmax-Qave 19.4-10.6, 17.4-9.3, and 16.9-8.7 ml/sec, respectively p<.005). The PVR was significantly reduced in all groups with a mean value of 11.8 vs. 11.9. vs. 12.1, in group A, B and C, respectively (p>0.05).
Concluding message
This prospective randomized study is the first to compare new minimally invasive approaches to TURP, still considered the gold standard, in the treatment of non-neurogenic LUTS secondary to BPO for mid prostate volumes 30-80 ml. Postoperative outcomes were more effective in the Aquabeam and Rezum groups in terms of sexual function and overall satisfaction, especially when evaluating the antegrade ejaculation sparing.
Disclosures
Funding None Clinical Trial Yes Registration Number IRB UNIVLSLTURO2020/7691 RCT No Subjects Human Ethics Committee IRB UNIVLSLTURO2020/7691 Helsinki Yes Informed Consent Yes
Citation

Continence 12S (2024) 101401
DOI: 10.1016/j.cont.2024.101401

23/11/2024 07:14:14