Long-Term Outcomes Following Bipolar Transurethral Plasma Enucleation of the Prostate: 10-Year Follow-Up

Abstract

Background and Purpose:

The aim of our study is to assess the long-term outcomes and safety of bipolar transurethral plasma enucleation of the prostate (B-TUEP) in patients with lower urinary tract symptoms (LUTS) in a single-center cohort study. Our focus is to evaluate the impact on outcomes after 10 years of follow-up (FUP) in terms of recurrence, LUTS, and patients' quality of life after B-TUEP in prostates between 30 and 80 cc.

Materials and Methods:

Between May 2010 and December 2011, all consecutive patients with benign prostatic hyperplasia undergoing B-TUEP were prospectively enrolled in our study. Data on patients' history, physical examination, prostate volumes, erectile function, prostate-specific antigen levels, International Prostate Symptoms Score (IPSS), and uroflowmetry were collected at 0, 1, 3, 6, 12, 24, 36, 60, and 120 months. Early and long-term complications were recorded.

Results:

A total of 50 consecutive patients underwent B-TUEP in our facility, all performed by a single surgeon (R.G.). Twelve patients were excluded during the 10 years. No patients had persistent bladder outlet obstruction (BOO) requiring reoperation. In terms of results, the improvement in IPSS was sustained throughout 5 years, and the mean difference from baseline at 5 years was 17 points, with similar results at 10 years. Erectile function was also slightly improved after surgery and maintained for the next 5 years, with a slight age-related decrease at 10 years. Furthermore, the improvements in maximum urine flow rate (Qmax) were maintained at 5 years, with a mean improvement of 16 mL/s, while at 10 years, it settled on a mean improvement from baseline of 12 mL/s.

Conclusions:

In our 10 years' experience, B-TUEP is a safe and highly effective technique for relieving BOO, with excellent outcomes and no recurrence at 10 years of FUP. Further multicenter studies should confirm our results.

Introduction

During the past two centuries, life expectancy has linearly increased. The high prevalence of disease and disability in the elderly will therefore impose major future challenges on governments, particularly in social health care.¹ Among these conditions, voiding dysfunction, due to its high prevalence, has a significant impact on socioeconomic conditions and predisposes to a poorer health-related quality of life (QoL) and at an increased risk of developing urinary tract infections.^2
–4 Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are considered a major condition in men over the age of 40, severely impacting their QoL. Many studies have shown a high prevalence of urinary symptoms starting from the age of 40, with about 3% of the male population affected, gradually increasing with age.⁵ The prevalence of moderate-to-severe LUTS in males increases 10% per decade from 40 to 79 years of age, and in men older than 80 years, 70% are affected by voiding symptoms.^2,6,7

Transurethral resection of the prostate (TURP) is currently a chosen treatment for BPH. According to the latest European guidelines, TURP may be considered the treatment of choice for prostates between 30 and 80 cc. For prostates larger than 80 cc results are lacking and contradictory. No studies on the optimal cutoff value exist, but complication rates increase with prostate size. Therefore, high-level evidence for larger prostates is limited.⁸ Nowadays, TURP can be performed using different ways and energies, ranging from monopolar energy, bipolar, holmium laser, green light laser, diode laser, thulium laser, and others.⁹

The introduction of bipolar technology has overcome the limitations of monopolar energy, but recurrence is still an important limitation, especially when compared with the latest enucleation techniques.^10,11 Improvement in International Prostate Symptom Score (IPSS), QoL score, and maximum urine flow rate (Qmax), with urodynamically proven deobstruction favoring plasmakinetic enucleation of the prostate, has been reported after a 3-year follow-up (FUP), in prostates between 30 and 80 cc.^12
–14

The aim of this study is to assess the safety, efficacy, and long-term durability of bipolar transurethral plasma enucleation of the prostate (B-TUEP) for the treatment of bladder outlet obstruction (BOO) due to BPH after a 10-year FUP.

Materials and Methods

After approval by the Internal Review Committee, all patients who underwent B-TUEP between May 2010 and December 2011 were prospectively enrolled. The study fully complied with the Helsinki Declaration, and all patients signed informed consent before the procedure. Inclusion criteria were as follows: (1) age >50 years; (2) IPSS >12 and/or ≥4 and/or Qmax <15 mL/s and/or not responding to medical therapy and/or not willing to undergo medical therapy. Exclusion criteria were a history of urethral, bladder or prostate surgery, postvoid residual (PVR) >300 mL, neurovesical dysfunction, prostate carcinoma, bladder carcinoma, urethral stricture, and loss to FUP before 12 months.

The following data were collected: age, comorbidities and clinical history, IPSS, International Index of Erectile Function (IIEF)-5, QoL score, prostate-specific antigen (PSA), prostate volume, hemoglobin, PVR, and uroflowmetry (UFR). Prostate volume was measured using a transrectal 7.5 MHz ultrasound probe (Bk-Medical) and calculated using the ellipsoid formula (π/6 × width × height × depth of prostate).

Operative technique

Each procedure was performed by a single expert surgeon (R.G.) using an Olympus SurgMaster UES-40 bipolar generator, OES-Pro bipolar resectoscope, continuous-flow saline irrigation, and button-type vaporesection electrodes (Olympus Europe, Hamburg, Germany). The procedure begins with an apical incision, with the button positioned laterally to the verumontanum. The surgical strategy is unaltered by prostatic anatomy, such as the presence or absence of a medium lobe. Afterward, the 5 and 7 o'clock incisions are extended by laterolateral movement and distoproximal compression of the button. The button induces progressive pedunculation while the adenoma is partially vaporized. The avascular pedunculated adenoma is subsequently removed using the loop. The final hemostasis is accomplished with the button.¹⁰

Surgical outcomes

We recorded operative time, resected adenoma weight, changes in hemoglobin levels, duration of bladder irrigation and catheterization time, postoperative hospital stay, and complications, if any. Serum hemoglobin was determined perioperatively and on postoperative day 1. All patients were evaluated at 1, 6, 12, 24, 36, 48, 60, and 120 months after surgery. Assessments included IPSS, Qmax, QoL, PVR, IIEF-5, PSA, and complications. Patient erectile function was evaluated using the IIEF-5 questionnaire. Perioperative complications have been described in our previous article.¹⁵ Postoperatively, early complications such as urethral stricture, residual adenoma, acute urinary retention, transient urinary incontinence, and readmission rate were recorded. In the long-term, reintervention rate and urethral strictures were recorded (Table 3).

Statistical analyses

Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL). Continuous variables are presented as mean ± standard deviation and were compared using the Mann–Whitney test. Categorical data (percentages) were compared using the chi-square test or Fisher's exact probability test. Differences from baseline were evaluated using the Wilcoxon (Table 1).

Table 1.

Baseline Characteristics of the Cohort Population

Age, year	64.3 ± 5.4
PV, mL	49.7 ± 14.24
PSA, ng/mL	2.63 ± 1.34
Operation time, minutes	48.1 ± 8.0
Enucleation time, minutes	44.1 ± 3.9
Enucleation weight, g	35.2 ± 8.1
Decrease in sodium, mmol/L	0.69 ± 0.42
Catheterization	2.2 ± 0.3
Hospital stay	2.6 ± 0.6

PSA = prostate-specific antigen; PV = prostatic volume.

Results

A total of 50 patients were initially enrolled in the study, but over the course of 5 years of FUP, 6 patients were lost due to severe BOO requiring bipolar transurethral incision of the prostate, 4 were excluded due to prostate cancer diagnosis, 2 were excluded due to nonmuscle invasive bladder cancer, 1 was excluded due to prostate cancer, and 2 were lost to FUP due to death caused by COVID-19 infection. Overall, we lost 24% of patients (12 pts) after 10 years from the initial population (Table 2).

Table 2.

Patients Excluded from the Analysis

Excluded patients
1st year	2 Bladder Neck Stenosis, 2 PCa
2nd year	1 PCa
3rd year	1 PCa
4th year	1 PCa and 1 MIBC
5th year	1 MIBC
6th year	1 PCa
7th year
8th year	2 death by Covid-19
9th year
10th year

MIBC = muscle invasive bladder cancer; PCa = prostate cancer.

In terms of outcomes, a gradual and constant improvement was observed in Qmax during the first 5 years after the surgery, with a considerable improvement when compared with the preoperative values (8.73 ± 3.20 mL/s vs 25 ± 3.4 mL/s). At 10 years of FUP, compared with the baseline, the mean improvement was 12 points (20.7 ± 2.8 mL/s).

Regarding the QoL, the results at 12 (1.25 ± 0.33), 24, 36, and 60 (1.05 ± 0.15) months showed a continuous improvement from the preoperative baseline (2.16 ± 1.12). At 10 years, the mean values were 1.6 ± 0.4, which were higher than the preoperative ones, on average.

The improvement in IPSS was sustained for all 5 years (21.72 ± 5.15 vs 5.3 ± 0.9), with a mean difference from the preoperative values of almost 17 points. After 10 years, there was a slight decline in the values (7.9 ± 1.3), but they remained well above the basal levels with a difference of about 14 points.

Regarding the baseline prostatic volume in our study cohort, it was found to be 49.7 ± 14.24 cc. Following endoscopic intervention, a significant reduction was maintained at 60 and 120 months, with mean volumes of 17 ± 5 and 19.7 ± 6.9 cc, respectively. After 10 years, the mean PVR was 33 ± 7 mL. The mean prostate volume found at 10 years was equal to 19.7 ± 6.9 cc, and at 5 years, it was 17 ± 5 cc. (Table 3).

Table 3.

Preoperative Data and Follow-Up of the Cohort Population (Numbers Indicate Mean Values with Standard Deviation, and p-Values of Comparison with Baseline)

	Baseline	12 months	24 months	36 months	48 months	60 months	120 months
Patients	50	46	46	43	41	41	38
Qmax (mL/s)	8.73 ± 3.20	22.3 ± 4.74(p < 0.0001)	23.2 ± 0.30(p < 0.0001)	25 ± 3.4(p < 0.0001)	25 ± 3.3(p < 0.0001)	25 ± 3.4(p < 0.0001)	20.7 ± 2.8(p < 0.0001)
QoL	2.16 ± 1.12	1.25 ± 0.33(p < 0.0001)	1.04 ± 0.20(p < 0.0001)	1.04 ± 0.20(p < 0.0001)	1.12 ± 0.30(p < 0.0001)	1.05 ± 0.15(p < 0.0001)	1.6 ± 0.3(p = 0.0036)
IPSS	21.72 ± 5.15	4.78 ± 2.36(p < 0.0001)	5.48 ± 3.05(p < 0.0001)	5.0 ± 2.2(p < 0.0001)	4.6 ± 0.9(p < 0.0001)	5.3 ± 0.9(p < 0.0001)	7.9 ± 1.3(p < 0.0001)
IIEF-5	19.6 ± 3.55	20.95 ± 2 .45(p = 0.0341)	21.13 ± 2.68(p = 0.0200)	21.9 ± 2.3(p = 0.0005)	21.8 ± 5.4(p = 0.0219)	21.8 ± 6.1(p = 0.0345)	18.3 ± 6.8(p = 0.2489)
PVR (mL)	90.1 ± 36.70	16.3 ± 9.9(p < 0.0001)	16.5 ± 6.66(p < 0.0001)	16 ± 6.9(p < 0.0001)	16 ± 6.7(p < 0.0001)	17 ± 6(p < 0.0001)	33 ± 7(p < 0.0001)
TRUS (cc)	49.7 ± 14.24	17.54 ± 5.55(p < 0.0001)	17.54 ± 5.55(p < 0.0001)	17 ± 17.0(p < 0.0001)	16 ± 5.0(p < 0.0001)	17 ± 5(p < 0.0001)	19.7 ± 6.9(p < 0.0001)
PSA (ng/mL)	2.63 ± 1.34	0.76 ± 0.61(p < 0.0001)	0.7 ± 0.51(p < 0.0001)	0.6 ± 0.18(p < 0.0001)	0.6 ± 0.26(p < 0.0001)	0.6 ± 0.43(p < 0.0001)	0.9 ± 0.8(p < 0.0001)

IIEF = International Index of Erectile Function; IPSS = International Prostate Symptoms Score; PVR = postvoid residual; Qmax = maximum urine flow rate; QoL = quality of life; TRUS = transrectal ultrasound scan.

However, the variation in PSA is worth noting. Compared with the baseline value (2.63 ± 1.34), we observed a reduction in the PSA value at 12, 24, and 36 months post-TURP. After 5 years, the mean PSA level was 0.6 ± 0.43, and after 10 years, it was 0.9 ± 0.8 ng/mL.

Regarding the baseline IIEF-5 score, we observed a continuous and gradual improvement at 12, 24, 36, and 60 months (21.8 ± 6.1). After 120 months, we reported a slight reduction in terms of the IIEF-5 score (18.3 ± 6.8), with 36.8% of patients reporting a score >21 (Table 3).

Discussion

With this study we want to confirm what has been proved about B-TUEP. This is a safe and long-lasting technique in patients with BOO secondary to BPH and effective to reducing complications while maintaining efficacy. In our study, only two patients presented bladder neck stenosis, both in the first 12 months after surgery, while no patients after. Furthermore, no patient needed endoscopic retreatment due to BOO secondary to benign prostatic enlargement. This is one of the first long-term studies on efficacy and outcomes of B-TUEP in patients with LUTS/BPH.

Surgical enucleation of prostate adenoma is a known technique in the last 100 years, and it was revisited for endoscopic approach by Japanese urologists in 1983.^16,17 However, we also experienced minimally invasive simple prostatectomy that includes laparoscopic simple prostatectomy and robot-assisted simple prostatectomy. According to the latest studies, we can consider these techniques safe and effective if compared with the endoscopic approach, mainly for large-volume prostates. We have similar short- and long-term outcomes for the two procedures, although the costs and surgical learning curve are greater.^17
–19

We registered an improvement in Qmax from the baseline, which was sustained at 1 year and maintained over 5 years of FUP. After 10 years, we confirmed the efficacy of B-TUEP, as evidenced by a good mean Qmax value of 20.7 ± 2.8 mL/s, which showed a slight decrease compared with the Qmax value at the 5-year FUP, likely due to population aging. At 12, 36, and 60 months, the QoL score improved significantly compared with the baseline score of 2.16 ± 1.12, with scores of 1.25 ± 0.33, 1.04 ± 0.2, and 1.05 ± 0.15, respectively. At 10 years, the QoL score was 1.6 ± 0.4, which is a good outcome considering the mean age of the study population, which was 73.9 ± 5.2 (Table 2). After 10 years of FUP, we observed significant improvements in IPSS, PVR, and IIEF-5 scores compared with baseline and 5-year FUP. The first two outcomes showed statistically significant differences (p < 0.0001) (Table 3).

The mean postoperative PSA was 0.6 ± 0.43 ng/mL after 5 years. PSA is recognized as a correlate of the amount of adenoma in the prostate and is a simpler parameter to use than transrectal ultrasound scan (TRUS) in determining prostate size.²⁰ A lower postoperative PSA level is a coherent parameter to evaluate the completeness of surgical resection and may predict a good long-term outcome. We observed a mean PSA value of 0.9 ± 0.8 ng/mL (p < 0.0001) after 10 years from surgery. According to Hosseini et al. these PSA changes were also associated with reduction in IPSS and increase in Qmax. However, if a persistently elevated PSA level is observed above the expected nadir level, physicians should consider the possibility of occult cancer.^21
–23

Many techniques of prostate enucleation have been described nowadays. We can name holmium laser enucleation of the prostate (HoLEP), which is considered one of the treatments of choice for moderate-to-severe LUTS secondary to BPH. It has been found to have beneficial aspects in terms of shorter catheterization and hospitalization times, reduced blood losses, fewer blood transfusions, and no significant differences in urethral strictures and stress urinary incontinence rates compared with monopolar transurethral resection of the prostate (M-TURP).^24,25 Gilling et al. conducted a study investigating the functional outcomes of HoLEP with a mean FUP period of 6.1 years. Their study included only 38 patients, with a mean IPSS of 8.5 Qmax of 19 ml/s.²⁶

Monopolar transurethral resection of the prostate compared with B-TURP results in no differences in short-term urethral stricture/bladder neck contracture rates, but bipolar energy is preferable to a monopolar one (especially if performed by trainees), due to a more favorable perioperative safety profile (elimination of TURP syndrome; lower clot retention/blood transfusion rates; shorter irrigation, catheterization, and possibly hospitalization times).^27,28 B-TUEP showed better safety and outcomes also if compared with B-TURP, in terms of perioperative and short-term complications; furthermore, IPSS and PVR are significantly lower and Qmax was improved. Despite this there were no significant differences in IEEF-5 scores, PVR, urethral stricture, urinary incontinence, or erectile dysfunction.^29,30

We first introduce the use of Olympus button to enucleate the prostate, proving safety and short/medium-term efficacy.^10,11 Becker et al. conducted a retrospective study on 500 patients who underwent transurethral vapor enucleation of the prostate to investigate the 5-year outcomes. The researchers found that the functional parameters of the patients remained significantly improved from their baseline values at the 48-month FUP. Specifically, at the 4-year postoperative mark, there was a significant difference in the median Qmax (19.1 mL/s vs 7.75 mL/s), PVR (31.9 mL vs 150 mL), IPSS (4.5 vs 24), and QoL (1 vs 5) as compared with their baseline values.³¹

In comparison, our study presents complete results from a relatively small and homogeneous cohort of consecutive patients who were assessed over a longer median FUP period of almost 10 years. Our UFR parameters and IPSS were similar to previous findings, which confirms the effectiveness of B-TUEP in relieving symptoms in the long term. Furthermore, our reoperation rate for BOO was 1%, which is consistent with rates reported for other surgical methods (<5%). Interestingly, we observed a decline in UFR parameters over the FUP period, while IPSS scores remained in the normal to mildly symptomatic range. This decline may be attributed to a decrease in detrusor functionality that typically occurs with increasing age, however our study is not powered enough to record these differences.³²

Currently, numerous techniques for prostate enucleation have been described, and HoLEP is considered one of the effective treatment options for managing moderate to severe lower LUTS that result from BPH. However, one of the limitations of this technique is the long learning curve required to acquire endoscopic skills, as the procedure is technically challenging. A retrospective study by Xiong et al. showed that the rate of conversion of TUEP procedure to TURP decreased after about 30 cases, while a learning plateau was reached after 50 cases.³³ This is also one of our limitations, as all surgical procedures were performed by a single expert surgeon R.G, and therefore, these achievements may not apply to all populations and series.

The major limitation of our study is the small sample size and the absence of a TURP control group, which may restrict the generalizability of our conclusions. Nevertheless, the scarcity of long-term data in the literature and the thorough FUP of our patients with UFR, PSA, and TRUS volume assessments are noteworthy strengths of this investigation. This study represents one of the few long-term studies investigating bipolar enucleation of the prostate in literature. If our findings are validated in larger, multicenter cohorts, our technique may emerge as a viable, safe, and effective alternative to TURP.

Conclusion

Current evidence suggests that B-TUEP is an effective and safe surgical treatment for benign prostatic obstruction, and it seems to offer a long durability and a low rate of reintervention also after 10 years' FUP, in patients with LUTS secondary to BPH. Randomized clinical trial and broader studies are needed to validate our preliminary experience and draw definitive conclusion on long-term outcomes after B-TUEP.

Footnotes

Authors' Contributions

R.G., G.B.F., and R.L. conceived the study and participated in the study design. R.G., G.B.F., B.C.G., and L.A. assisted in collecting the data. R.G., G.B.F., B.C.G., L.A., F.B., R.D., J.G., M.V., S.R., and R.L. analyzed the data. G.B.F., F.B., and R.G. drafted and edited the article. All authors approved the final version. All authors have read and agreed to the published version of the article.

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study that we were able to contact.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

Abbreviations Used

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