Comparison of traditional outcome measures and self-assessed goal achievement in patients treated surgically for benign prostatic hyperplasia.

PURPOSE: To determine self-assessed goal achievement (SAGA) outcomes in men treated surgically for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) and compare them to the traditional outcome measures. METHODS: Single-center analysis of prospective database of men undergoing surgical treatment of LUTS/BPO at a single institution between July 2019 and March 2021. We assessed individual goals, traditional questionnaires, and functional outcomes prior to treatment, and at first follow-up after 6-12 weeks. We compared SAGA outcomes 'overall goal achievement' and 'satisfaction with treatment' to subjective and objective outcomes using Spearman's rank correlations (rho). RESULTS: A total of sixty-eight patients completed the individual goal formulation prior to surgery. Preoperative goals varied between different treatments and individuals. IPSS correlated with 'overall goal achievement' (rho = - 0.78, p < 0.001) and 'satisfaction with treatment' (rho = - 0.59, p < 0.001). Similarly, the IPSS-QoL was correlated with overall goal achievement (rho = - 0.79, p < 0.001) and satisfaction with treatment (rho = - 0.65, p < 0.001). No correlation was seen between SAGA outcomes and functional outcomes Qmax and PVR. CONCLUSIONS: SAGA represents a uniquely patient-specific outcome measure. Our study is, to our knowledge, the first to assess patient-specific goals prior to surgery and examine SAGA outcomes following treatment in men suffering from LUTS/BPO. The correlation of SAGA outcomes with IPSS and IPSS-QoL highlight the importance of this well-established questionnaire. Functional outcomes do not necessarily reflect patient's goals and may rather be considered physician-directed outcomes.

In-hospital cost analysis of aquablation compared with transurethral resection of the prostate in the treatment of benign prostatic enlargement.

PURPOSE: To compare in-hospital treatment costs of aquablation and transurethral resection of the prostate (TURP) in the treatment of benign prostatic enlargement. PATIENTS AND METHODS: Patient data and procedural details were derived from a prospective database. In-hospital costs were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs including those arising from surgical procedures, consumables, personnel and accommodation were analysed for 24 consecutive patients undergoing aquablation and compared with 24 patients undergoing TURP during the same period. Mean total costs and mean costs for individual expense items were compared between treatment groups with t-tests. RESULTS: Mean total costs per patient (± standard deviation) were higher for aquablation at EUR 10,994 ± 2478 than for TURP at EUR 7445 ± 2354. The mean difference of EUR 3549 was statistically significant (p <0.001). Although the mean procedural costs were significantly higher for aquablation (mean difference EUR 3032; p <0.001), costs apart from the procedure were also lower for TURP, but the mean difference of EUR 1627 was not significant (p <0.327). Medical supplies were mainly responsible (mean difference EUR 2057; p <0.001) for the difference in procedural costs. CONCLUSIONS: In-hospital costs are significantly higher for aquablation than for TURP, mainly due to higher costs of medical supplies for the procedure. This difference should be taken into consideration, at least in patients for whom the different side effect profiles of both treatments are irrelevant.

Aquablation versus holmium laser enucleation of the prostate in the treatment of benign prostatic hyperplasia in medium-to-large-sized prostates (ATHLETE): protocol of a prospective randomised trial.

INTRODUCTION: A novel method for the surgical treatment of benign prostatic hyperplasia (BPH) called Aquablation has become commercially available. Previous studies have been able to show similar functional results when compared with transurethral resection of the prostate and a high efficacy has been demonstrated when this approach is applied to patients with a prostate size of 80-150 cm3.Holmium laser enucleation of the prostate (HoLEP) is a well-established procedure in the surgical treatment of BPH in prostate glands larger than 30 mL and a first-line therapy in glands over 80 mL. To date, no data are available whether Aquablation is non-inferior compared with HoLEP in the treatment of patients with medium-to-large-sized prostates regarding safety and efficacy. METHODS AND ANALYSIS: This is a prospective, randomised, open-label, non-inferiority clinical trial conducted at a Swiss centre of tertiary care. The primary outcome is assessment of non-inferiority of Aquablation compared with HoLEP in reducing lower urinary tract symptoms due to benign prostatic obstruction measured by the International Prostate Symptom Score (IPSS). Randomisation will be performed using secuTrial, stratifying on age (<70 years, 70+ years) and prostate volume (<100 mL, 100+ mL). Both interventions are performed in an inpatient setting and regular follow-up controls starting 8 weeks after intervention and continuing up to 5 years will be performed. The primary outcome (change in IPSS from baseline to 6 months) will be tested for non-inferiority with a one-sided t-test. Secondary outcomes, such as efficacy parameters, several patient-reported outcome measures, and periprocedural and safety parameters will be described by calculating means or relative frequencies for each treatment group and testing differences with two-sided standard superiority tests. ETHICS AND DISSEMINATION: The study was approved by the local ethics committee (EKOS 2020-02353). Results of the primary endpoint and each of the secondary endpoints will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04560907).

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial.

BACKGROUND: Prostatic artery embolisation (PAE) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (LUTS/BPO) still remains under investigation. OBJECTIVE: To compare the efficacy and safety of PAE and transurethral resection of the prostate (TURP) in the treatment of LUTS/BPO at 2 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A randomised, open-label trial was conducted. There were 103 participants aged ≥40 yr with refractory LUTS/BPO. INTERVENTION: PAE versus TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: International Prostate Symptoms Score (IPSS) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated. Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests. RESULTS AND LIMITATIONS: The mean reduction in IPSS after 2 yr was 9.21 points after PAE and 12.09 points after TURP (difference of 2.88 [95% confidence interval 0.04-5.72]; p = 0.047). Superiority of TURP was also found for most other patient-reported outcomes except for erectile function. PAE was less effective than TURP regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31-240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70-31.38]; p = 0.005). Adverse events were less frequent after PAE than after TURP (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar. Ten patients (21%) who initially underwent PAE required TURP within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and, therefore, represents a limitation of the study. CONCLUSIONS: Inferior improvements in LUTS/BPO and a relevant re-treatment rate are found 2 yr after PAE compared with TURP. PAE is associated with fewer complications than TURP. The disadvantages of PAE regarding functional outcomes should be considered for patient selection and counselling. PATIENT SUMMARY: Prostatic artery embolisation is safe and effective. However, compared with transurethral resection of the prostate, its disadvantages regarding subjective and objective outcomes should be considered for individual treatment choices.

In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial.

OBJECTIVES: To perform a post hoc analysis of in-hospital costs incurred in a randomized controlled trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). PATIENTS AND METHODS: In-hospital costs arising from PAE and TURP were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs, including those arising from surgical and interventional procedures, consumables, personnel and accommodation, were analysed for all of the study participants and compared between PAE and TURP using descriptive analysis and two-sided t-tests, adjusted for unequal variance within groups (Welch t-test). RESULTS: The mean total costs per patient (±sd) were higher for TURP, at €9137 ± 3301, than for PAE, at €8185 ± 1630. The mean difference of €952 was not statistically significant (P = 0.07). While the mean procedural costs were significantly higher for PAE (mean difference €623 [P = 0.009]), costs apart from the procedure were significantly lower for PAE, with a mean difference of €1627 (P < 0.001). Procedural costs of €1433 ± 552 for TURP were mainly incurred by anaesthesia, whereas €2590 ± 628 for medical supplies were the main cost factor for PAE. CONCLUSIONS: Since in-hospital costs are similar but PAE and TURP have different efficacy and safety profiles, the patient's clinical condition and expectations - rather than finances - should be taken into account when deciding between PAE and TURP.

Is absorption of irrigation fluid a problem in Thulium laser vaporization of the prostate? A prospective investigation using the expired breath ethanol test.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men. If medical treatment fails, monopolar transurethral resection of the prostate (TUR-P) is still considered as the standard treatment. The proportion of high-risk patients with cardiac comorbidities increases and TUR-P goes along with a relevant perioperative risk. Especially large volume influx of irrigation fluid and transurethral resection syndrome (TUR syndrome) represent serious threats to these patients. Using isotonic saline as irrigation fluid like in transurethral laser vaporization (TUV-P), TUR syndrome can be prevented. However, no prospective trial has ever assessed occurrence or extent of irrigation fluid absorption in Thulium Laser TUV-P. METHODS/DESIGN: This is a single-center prospective trial, investigating, if absorption of irrigation fluid occurs during Thulium Laser TUV-P by expired breath ethanol test. The expired breath ethanol technique is an established method of investigating intraoperative absorption of irrigation fluid: A tracer amount of ethanol is added to the irrigation fluid and the absorption of irrigation fluid can be calculated by measuring the expiratory ethanol concentrations of the patient with an alcohol breathalyzer. Fifty consecutive patients undergoing TUV-P at our tertiary referral center are included into the trial. Absorption volume of irrigation fluid during Thulium Laser TUV-P is defined as primary endpoint. Pre- to postoperative changes in bladder diaries, biochemical and hematological laboratory findings, duration of operation and standardized questionnaires are assessed as secondary outcome measures. DISCUSSION: The aim of this study is to assess the safety of Thulium Laser TUV-P in regard to absorption of irrigation fluid.