Introduction. Original Article: Clinical Investigation. Yosuke Hirasawa, 1 Yuji Kato 2 and Kiichiro Fujita 2

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1 International Journal of Urology (2018) 25, doi: /iju Original Article: Clinical Investigation Age and prostate volume are risk factors for transient urinary incontinence after transurethral enucleation with bipolar for benign prostatic hyperplasia Yosuke Hirasawa, 1 Yuji Kato 2 and Kiichiro Fujita 2 1 Department of Urology, Tokyo Medical University, Tokyo, and 2 Department of Urology, Kato Urological Clinic, Saitama, Japan Abbreviations & Acronyms BPH = benign prostatic hyperplasia HoLEP = holmium laser enucleation of prostate HR = hazard ratio IPSS = International Prostate Symptom Score OT = operative time PSA = prostate-specific antigen PSW = prostate specimen weight PV = prostate volume QOL = quality of life Q max = maximum flow rate by uroflowmetry Q ave = average flow rate by uroflowmetry TRUS = transrectal ultrasonography TUEB = transurethral enucleation with bipolar TUI = transient urinary incontinence TURP = transurethral resection of the prostate UI = urinary incontinence Correspondence: Yosuke Hirasawa M.D., Department of Urology, Tokyo Medical University, Nishishinjuku, Shinjuku-ku, Tokyo , Japan. wbqmd473@ yahoo.co.jp Received 23 April 2017; accepted 31 August Online publication 3 October 2017 Objectives: To investigate the predictive factors for transient urinary incontinence after transurethral enucleation with bipolar. Methods: We retrospectively analyzed the data of 584 patients who underwent transurethral enucleation with bipolar between December 2011 and September 2016 operated by a single surgeon. Urinary incontinence after transurethral enucleation with bipolar was defined as involuntary leakage of urine that required the use of pads. It was evaluated at 1 week, and 1, 3, 6, 12 and 24 months after transurethral enucleation with bipolar. We defined transient urinary incontinence as urinary incontinence persisting up to 1 month after transurethral enucleation with bipolar. Based on independent risk factors identified by a multivariate stepwise logistic regression analysis, a nomogram to predict transient urinary incontinence was developed. Results: Of the 584 patients, 17.3%, 13.5%, 3.1%, 0.41%, and 0% patients had urinary incontinence at 1 week, 1, 3, 6 and 12 months after transurethral enucleation with bipolar, respectively. The mean (standard error) age was years, estimated prostate volume was cm 3, operative time was min and the prostate specimen weight was g. On univariate analysis, age, prostate volume estimated by transrectal ultrasonography, prostate-specific antigen, prostate specimen weight, operative time, prostate specimen weight/prostate volume and prostate specimen weight/operative time were significant predictive factors for transient urinary incontinence after transurethral enucleation with bipolar. On multivariate analysis, age (hazard ratio 1.07, P-value = ) and prostate volume (hazard ratio 1.03, P-value < ) were independent risk factors for transient urinary incontinence after transurethral enucleation with bipolar. Conclusions: Age and prostate volume estimated by transrectal ultrasonography seem to represent significant independent risk factors for transient urinary incontinence after transurethral enucleation with bipolar. This should be well discussed with the patient before surgery. Key words: benign prostatic hyperplasia, prostate, transurethral enucleation with bipolar, urinary incontinence. Introduction TUI can occur after any surgical treatment for BPH, including conventional TURP, 1,2 prostate enucleation such as HoLEP and TUEB. 5,6 TUI has been recognized as one of the most distressing postoperative complications for both clinicians and patients TUI after surgery for benign disease (e.g. endoscopic surgery for BPH) makes it a more sensitive problem than it is after surgery for malignant disease (e.g. radical prostatectomy), as these endoscopic surgeries mainly focus on the patient s QOL before and after surgery. It appears that the rate of TUI after enucleation endoscopic surgery for BPH is somewhat higher than that after traditional TURP. 9 Montorsi et al. showed that TUI was more common after HoLEP (44% at 1 month after surgery) than TURP (38.6% at 1 month after surgery), leading to a lower preference among clinicians in adopting the enucleation techniques, such as HoLEP and TUEB. 9 Cho et al. reported that the rate of TUI at 1 month after HoLEP was 15.1%, and its rate improved to 5.0% at 6 months after HoLEP. 3 Although TUI after endoscopic surgery for BPH can The Japanese Urological Association

2 Risk factors for TUI after TUEB spontaneously improve within a few months, it remains a major complication, causing a negative impact on the patient s QOL. However, there has been no study to investigate the risk factors for TUI after TUEB. Thus, this is the first study aimed at evaluating the risk factors for TUI after TUEB. Methods Study design and end-point After obtaining the institutional ethics committee approval, we retrospectively analyzed the data of 584 consecutive patients who underwent TUEB for symptomatic BPH at the hands of a single surgeon (YK) between December 2011 and August TUEB using the characteristic loop was first developed and introduced by Ken Nakagawa and Olympus Corporation (Tokyo, Japan). TUEB is safe, effective and can be used as a procedure for patients with BPH. 5,6,11,12 This novel enucleation technique is especially useful for urologists, in hospitals where no laser system is available. 5 Preoperative and perioperative evaluation included PSA, IPSS and QOL score, and uroflowmetry measurements, OT, PSW, PSW/PV and PSW/OT. Postoperative complications including UI were also recorded. All patients underwent TRUS preoperatively, to measure the estimated PV. All patients underwent day care surgery under lumbar anesthesia. All patients were evaluated for the occurrence of UI postoperatively at 1 week, as well as at 1, 3, 6, 12 and 24 months after surgery. UI was defined as involuntary leakage of urine including both stress and urge UI that required the use of pads, in accordance with the recommendations of the International Continence Society. In the present study, we defined TUI as any UI up to 1 month after TUEB, which resolved spontaneously by 12 months after TUEB. The potential predictive factors for TUI after TUEB included clinical factors, such as patient s age, PV estimated by TRUS, serum PSA, IPSS, QOLs, OT, PSW, PSW/PV, PSW/OT, uroflowmetry findings and surgeon s experience. Surgeon s experience means the continuous variable from the first case to the 584th case of TUEB by a single surgeon. Operative procedure and technique TUEB represents endoscopic blunt enucleation of the prostate using the Olympus SurgMaster (Olympus Europa Holding GmbH, Hamburg, Germany) TURis system and the TUEB loop (Olympus Corporation). The TUEB loop consists of two parts including a spatula for blunt adenoma enucleation and the standard tungsten wire loop for hemostasis by the bipolar system. All procedures were carried out by a single surgeon (YK). The author (Hirasawa et al.) has previously described the TUEB technical details. 5 Briefly, after cystoscope insertion, resection was made at the 12 o clock position and then at the 6 o clock position to make it a two-block adenoma in the case of bilobular hypertrophy. In the case of trilobular hypertrophy, resection was made at the 12 o clock position, then at the 5 and 7 o clock positions. Next, the mucosa at the apical adenoma was circumferentially incised up to the depth of the surgical capsule. Both of the lateral lobes and middle lobe were dissected off the surgical capsule, in a retrograde fashion from the apex towards the bladder using the TUEB loop, with arrest of bleeding. Instead of releasing the lobes into the bladder, they were left attached at the bladder neck by a narrow mushroom-like pedicle. Fragmentation of the enucleated lobes hanging at the bladder neck was carried out by traditional electrocautery wire loop resection, whereas the devascularized lobes were still connected to the surgical capsule by a narrow pedicle. This is known as the mushroom technique. Statistical analysis Statistical analyses comparing each outcome between patients with TUI and patients without TUI after surgery were carried out using the Student s t-test for continuous variables, and the v 2 -test for categorical variables. Independent risk factors for the prediction of TUI after TUEB were identified using a multivariate stepwise logistic regression analysis. We developed the nomogram to predict TUI after TUEB based on these independent preoperative risk factors by using R for Windows (R Foundation for Statistical Computing, Vienna, Austria; The predicted probability of TUI after TUEB was estimated in accordance with the results of a multivariate stepwise logistic regression analysis. Model coefficients were selected to optimize the ability of the model to predict the probability of TUI after TUEB. Calibration plots were used to graphically evaluate the association between the predicted probabilities of TUI after TUEB and the observed proportions. All analyses including the development of nomogram were carried out using R for Windows, version For all statistical comparisons, differences with P < 0.05 were considered significant. Results Patients characteristics in the present study are listed in Table 1. Mean (standard error) age was years. Mean prostate volume estimated by TRUS was cc, mean operative time was min and the mean specimen weight was g. Rate of UI ( 1 pad) was 13.5% at 1 month after TUEB, but the rate dramatically decreased to 3%, 0.41%, 0%, and 0% at 3, 6, 12 and 24 months after TUEB, respectively (Table 2). Therefore, almost all UI spontaneously resolved within 3 6 months in the present study. No patients experienced UI at 12- and 24-month follow up. Therefore, there were no patients with permanent UI after TUEB in the present study. Differences between patients with TUI and those without TUI are summarized in Table 1. As shown in Table 1, patients in the TUI group were significantly older than patients in the group without TUI. PV of patients in the TUI group was also significantly higher than that of patients in the group without TUI. Furthermore, PSA, OT, PSW, PSW/ PV and PSW/OT were significantly higher in patients in the TUI group than in patients without TUI. On univariate analysis, age (HR 1.06, P-value = ), PV estimated by TRUS (HR 1.02, P-value < ), PSA 2017 The Japanese Urological Association 77

3 Y HIRASAWA ET AL. Table 1 Association between each variable and occurrence of TUI at 1 month after TUEB Parameters All n = 584 Group 1: patients with TUI n = 79 Group 2: patients without TUI n = 505 P-value (group 1 vs group 2) Preoperative parameters Mean age (years) Mean serum PSA (ng/ml) Prostate volume (cc) < Baseline IPSS Baseline QOLs Baseline Q max (ml/s) Baseline Q ave (ml/s) Urinary retention, no (%) 41 (7.0%) 5 (6.3%) 36 (7.1%) 1.0 Perioperative parameters Total operative time (min) < Specimen weight (g) < Rate of specimen weight/prostate volume (%) Rate of specimen weight/operative time (%) Rate of PSA reduction (%) Data are mean standard error of the mean. Table 2 Urinary continence at 1 week, and 1, 3, 6, 12 and 24 months after TUEB 1 week 1 month 3 months 6 months 12 months 24 months No. patients pad per day (%) pad per day (%) pads per day (%) (HR 1.13, P = ), PSW (HR 1.03, P-value < ), OT (HR 1.02, P-value < ), PSW/PV (HR 1.03, P- value = ) and PSW/OT (HR 4.3, P-value = 0.026) were significant predictive factors for TUI after TUEB; however, IPSS, QOL, Q max, history of preoperative urinary retention and surgeon s experience were not significant (Table 3). On multivariate analysis, age (HR 1.07, P-value = ) and PV (HR 1.03, P-value < ) were independent risk factors for TUI after TUEB (Table 3). Based on these results, we developed a nomogram that graphically shows the multivariate impact of each variable (Fig. 1). The concordance index of this model was Calibration plots are shown Table 3 Univariate and multivariate stepwise logistic regression analyses for predicting TUI at 1 month after TUEB Univariate analysis Multivariable analysis Parameters HR (95% CI) P-value HR (95% CI) P-value Age (years) 1.06 ( ) ( ) Estimated prostate volume by TRUS (cc) 1.02 ( ) < ( ) < Preoperative IPSS 0.99 ( ) 0.56 Preoperative QOL 0.96 ( ) 0.69 Preoperative Q max (ml/s) 1.02 ( ) 0.57 Preoperative Q ave (ml/s) 1.02 ( ) 0.74 Urinary retention 0.88 ( ) 0.80 PSA (ng/ml) 1.13 ( ) Operative time (min) 1.02 ( ) < Prostatic specimen weight (g) 1.03 ( ) < Prostatic specimen weight/estimated 1.03 ( ) prostate volume (g/cc) Prostatic specimen weight/operative time (g/min) 4.3 ( ) Surgeon experience (cases) 1.0 ( ) The Japanese Urological Association

4 Risk factors for TUI after TUEB Points Age Prostate volume Total points in Figure 2. The differences between the observed and predicted probabilities were within 2% for 90% of the patients (Fig. 2). Discussion Probability of TUI after TUEB Fig. 1 A nomogram (patient s age and preoperatively estimated prostate volume by transrectal ultrasound sonography) to predict TUI at 1 month after TUEB. The nomogram is used by locating the patient position on each factor. Each factor has corresponding prognostic points (top axis). The points for each factor are added, and the probability of TUI at 1 month after TUEB is estimated from the bottom line. Observed frequency Apparent Bias-corrected Ideal Predicted probability of TUI after TUEB Fig. 2 Nomogram calibration. The ideal line at 45 (dashed line) indicates the ideal nomogram reference line. The apparent line (dotted line) was calculated directly from the dataset. The bias-corrected line (continuous line) is a line adjusted by bootstrap with 1000 resamples. (n = 584, 0.9 quantile of absolute error = 2.0%). Endoscopic enucleation of the prostatic adenomas is increasing as a novel surgical treatment for BPH. However, TUI after the procedure is the main adverse event. The aim of surgical treatment for BPH is to remove the prostatic adenoma, thereby improving the uroflowmetry results, patients symptoms and QOL. TUI after surgery for BPH might restrict patients activity of daily living and impair QOL. 13,14 TUI after endoscopic enucleation of the prostate occurred in 13.5% of patients at 1 month after TUEB in the present study and in % after HoLEP in previous studies. 9,15,16 Therefore, it is important to determine clinical incidence and risk factors of TUI after surgical treatment for BPH. However, there has been no study to investigate its risk factors after TUEB. Thus, this is the first study to evaluate risk factors of TUI after TUEB. In the present study, age and prostate volume were independent risk factors for TUI at 1 month after TUEB. Postoperatively, the capacity of prostatic fossa can increase with increasing PV, after complete removal of the adenoma by an enucleation surgical procedure of the prostate. This causes urine trapping and leakage with stress maneuvers in the short-term, although prostatic specimen weight was not a significant risk factor for TUI in the present study. This could be because of its significant correlation with prostate volume on multivariate analysis. In their review article, Walz et al. mentioned an inner muscle layer of the urethral sphincter that surrounds the urethra, and consists of smooth muscle fibers and elastic tissue. 17 The retrograde dissection of the apex of the prostate in the TUEB might stretch the inner longitudinal layer around the apical gland. This could result in transient damage of the urethral sphincter, leading to TUI. Operative time for enucleating the adenoma increases with increasing prostate volume, and it causes stretching of the inner longitudinal layer around the apical gland for a longer time. This could be the reason why patients with larger prostates experienced more TUI after TUEB. In contrast, open prostatectomy does not stretch this inner layer of the sphincter because of antegrade dissection from the bladder neck to the apex, resulting in a lower incidence of TUI. In fact, the incidence of TUI after open prostatectomy reported by previous studies was lower at %. 18,19 The overall occurrence of TUI after TUEB in the present study was higher than that after open prostatectomy. Shigemura et al. showed that patient age and prostate volume were significant predictive factors for TUI at 1 month after HoLEP. 20 Additionally, Nam et al. also showed that advanced age and longer operative time were significant risk factors for TUI after HoLEP. 4 They suggested that the sphincter tissue is more fragile and sparse in the elderly, compared with young men, leading to an increased susceptibility to damage while forcing the tissue when enucleating the adenoma. 4 The results of these two studies seem to be similar to the present results. However, operative time was not a significant risk factor for TUI on multivariate analysis in our study. This could be because of its significant correlation with prostate volume, as seen on multivariate analysis. TUI is one of the most distressing postoperative complications of TUEB or HoLEP for patients with BPH. 13,14 In the present study, although TUI occurred in 17.3% of all patients after TUEB, 82.2%, of them showed spontaneous recovery within 3 months. Involuntary leakage of urine leading to a 2017 The Japanese Urological Association 79

5 Y HIRASAWA ET AL. hygienic and social inconvenience can cause significant impairment of activity of daily living or QOL of patients for several months after enucleation surgery. The complaints of UI can be very stressful to both clinicians and patients. Hence, this common adverse event should be well discussed with the patients before surgery; more so, because there are other alternatives for treatment of BPH, such as medication to reduce PV. However, there has been no preoperative nomogram to predict TUI after TUEB or HoLEP. We developed a nomogram based on two preoperative risk factors to predict TUI after TUEB. This predictive nomogram might be useful to help patients make a decision about their choice of treatment for BPH. There were several limitations to the present study. The major limitation of the present study was its retrospective design. As a result, a systematic follow up with urodynamic assessment or erectile function data could not be recorded, which would have been interesting to investigate. Second, we documented UI based on pad usage, and did not assess the type of UI, such as stress or urgency or mixed UI. However, the diagnosis of stress/urgency/mixed urinary incontinence depends on the patients subjective complaint according to the recommendations of the International Continence Society, and there are no standard criteria for reporting urinary incontinence. Unfortunately, the present data also lack patient subjective complaint, and there were only objective data on pad use, which proved whether patients encountered UI after surgery or not. Additionally, the present data lack some important patients characteristics, such as body mass index or medical history (e.g. diabetes or brain infarction), or details of IPSS or intravesical prostatic protrusion. As a result, we did not investigate the correlation between body mass index or medical history, or details of IPSS or intravesical prostatic protrusion and TUI. These factors have possibilities to affect TUI after surgery. Therefore, we should investigate the correlation between these factors and TUI in the future. In addition, in this single surgeon s series, the surgeon s experience was not a significant risk factor for TUI after TUEB. However, the surgeon s experience might become a risk factor for TUI like other complications in other surgeon s series. Therefore, we should investigate whether surgeon s experience become a risk factor for TUI after TUEB in multisurgeon series in the future. Finally, although we validated our prediction nomogram and the C-index (0.690) was not bad, it has not been validated in an independent cohort. Therefore, to confirm whether our prediction nomogram is correctly useful in the real clinical practice, we require external validation in another institution in the future. In conclusion, we found that age and PV estimated by TRUS were significant independent risk factors for TUI at 1 month after TUEB. It should be well discussed with the patient before surgery. Conflict of interest None declared. References 1 Seaman EK, Jacobs BZ, Blaivas JG, Kaplan SA. Persistence or recurrence of symptoms after transurethral resection of the prostate: a urodynamic assessment. J. Urol. 1994; 152: Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP) incidence, management, and prevention. Eur. Urol. 2006; 50: Cho MC, Park JH, Jeong MS et al. Predictor of de novo urinary incontinence following holmium laser enucleation of the prostate. Neurourol. Urodyn. 2011; 30: Nam JK, Kim HW, Lee DH, Han JY, Lee JZ, Park SW. Risk factors for transient urinary incontinence after holmium laser enucleation of the prostate. World J. Mens Health 2015; 33: Hirasawa Y, Ide H, Yasumizu Y, Hoshino K, Ito Y, Masuda T. Comparison of transurethral enucleation with bipolar and transurethral resection in saline for managing benign prostatic hyperplasia. BJU Int. 2012; 110(11 Pt C): E Hirasawa Y, Kato Y, Fujita K. Transurethral enucleation with bipolar for benign prostatic hyperplasia: 2-year outcomes and the learning curve of a single surgeon s experience of 603 consecutive patients. J. Endourol. 2017; 31: Mitropoulos D, Papadoukakis S, Zervas A, Alamanis C, Giannopoulos A. Efficacy of tolterodine in preventing urge incontinence immediately after prostatectomy. Int. Urol. Nephrol. 2006; 38: Kuntz RM, Lehrich K, Ahyai S. Does perioperative outcome of transurethral holmium laser enucleation of the prostate depend on prostate size? J. Endourol. 2004; 18: Montorsi F, Naspro R, Salonia A et al. Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center, prospective, randomized trial in patients with obstructive benign prostatic hyperplasia. J. Urol. 2004; 172(5 Pt 1): Seki N, Mochida O, Kinukawa N, Sagiyama K, Naito S. Holmium laser enucleation for prostatic adenoma: analysis of learning curve over the course of 70 consecutive cases. J. Urol. 2003; 170: Sato K, Obinata D, Funakoshi D et al. Efficacy of transurethral prostate enucleation by bipolar system for patients with benign prostatic hyperplasia. Minerva Urol. Nefrol. 2016; 68: Kawamura Y, Tokunaga M, Hoshino H, Matsushita K, Terachi T. Clinical outcomes of transurethral enucleation with bipolar for benign prostatic hypertrophy. Tokai J. Exp. Clin. Med. 2015; 40: Coyne KS, Zhou Z, Thompson C, Versi E. The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int. 2003; 92: Fultz NH, Herzog AR. Self-reported social and emotional impact of urinary incontinence. J. Am. Geriatr. Soc. 2001; 49: Shah HN, Mahajan AP, Hegde SS, Bansal MB. Peri-operative complications of holmium laser enucleation of the prostate: experience in the first 280 patients, and a review of literature. BJU Int. 2007; 100: Hurle R, Vavassori I, Piccinelli A, Manzetti A, Valenti S, Vismara A. Holmium laser enucleation of the prostate combined with mechanical morcellation in 155 patients with benign prostatic hyperplasia. Urology 2002; 60: Walz J, Burnett AL, Costello AJ et al. A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy. Eur. Urol. 2010; 57: Tubaro A, Carter S, Hind A, Vicentini C, Miano L. A prospective study of the safety and efficacy of suprapubic transvesical prostatectomy in patients with benign prostatic hyperplasia. J. Urol. 2001; 166: Helfand B, Mouli S, Dedhia R, McVary KT. Management of lower urinary tract symptoms secondary to benign prostatic hyperplasia with open prostatectomy: results of a contemporary series. J. Urol. 2006; 176(6 Pt 1): Shigemura K, Tanaka K, Yamamichi F, Chiba K, Fujisawa M. Comparison of predictive factors for postoperative incontinence of holmium laser enucleation of the prostate by the surgeons experience during learning curve. Int. Neurourol. J. 2016; 20: The Japanese Urological Association

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