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Bipolar Transurethral Resection in Saline (TURis

Ò

):

Outcome and Complication Rates

After the First 1000 Cases

Paolo Puppo, M.D.,1,2Franco Bertolotto, M.D.,1Carlo Introini, M.D.,2 Francesco Germinale, M.D.,1Luca Timossi, M.D.,1and Angelo Naselli, M.D.2

Abstract

Objective: TURisÒ is an emerging technique that shows the same efficacy of monopolar resection. However, there is currently little available data on the safety of bipolar devices. We assessed outcome and safety of TURis on a large cohort of patients with at least 6 months’ follow-up.

Patients and Methods:Between January 2006 and October 2007, 1000 consecutive transurethral resection (TUR), 376 transurethral resection of prostate, 480 transurethral resection of bladder neoplasm, and 144 transurethral incision of prostate were performed. All procedures were carried out with a bipolar device in physiologic saline (TURis). The resectoscope used was an Olympus 26F in continuous flow–type Iglesias with continuous aspi-ration. The loops were all disposable=single use. The incidence of unwanted stimulation of the obturator reflex, TUR syndrome, thermal skin lesion, blood transfusion, urethral strictures, and bladder neck contractures were recorded.

Results:None of the patients operated experienced a TUR syndrome or a thermal skin lesion. The median follow-up of the entire cohort was 12 months (range, 6–24 months); 663 patients had at least 1-year follow-follow-up (66.3%). Urethral stricture occurred in 27 patients (2.7%). Four patients developed a bladder neck contracture after transurethral resection of prostate (1%). Early postoperative clot retention occurred in 21 patients (2.1%), and 11 patients needed one or more transfusion (1.1%). Only six patients (2%) submitted to TUR of a neoplastic lesions at the lateral bladder wall experienced an unwanted trigger of the obturator reflex.

Conclusions:TURis offers the patient the same results as monopolar technology guaranteeing maximum safety without increasing the incidence of urethral strictures.

Introduction

V

ideo transurethral resection today is the gold standard for the treatment of benign prostatic hyper-plasia and superficial bladder cancer.1 Notwithstanding the continuous amelioration of the surgical equipment and the progress made in anesthesiology, the intervention still has a certain morbidity.2,3Transurethral resection (TUR) syndrome, for example, is a rare4but serious clinical complication of a monopolar resection carried out with a electrolyte-free irriga-tion soluirriga-tion (e.g., glycine). The latter irrigairriga-tion soluirriga-tion is further toxic in particular concentrations and can aggravate the clinical picture. to reduce the risks of the monopolar circuit, resectoscopes are today commercially available, which, by behaving like electric dipoles, allow the patient to be excluded

from the circuit. This allows the use of physiologic saline as irrigation solution annulling the risk of a TUR syndrome and an intoxication by glycine. These bipolar electrosurgical units are available from different manufacturers. In the literature many papers confirm the equivalence in clinical outcome be-tween mono and bipolar resection,5but there is currently little available data on the more effective safety of bipolar devices, especially on the incidence of urethral stricture.

Patients and Methods

Between January 2006 and October 2007, 1000 consecutive bipolar TUR, 376 transurethral resection of prostate (TURP), 480 transurethral resection of bladder neoplasm (TURB), and 144 transurethral incision of prostate (TUIP) were performed.

1

Department of Urology ASL1 Liguria, Imperia, Italy.

2Urology Unit, National Institute for Cancer Research, Genova, Italy.

ªMary Ann Liebert, Inc. Pp.&&&–&&&

DOI: 10.1089=end.2009.0011

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The procedure started always with a urethrotomy in cases with an inappropriate relationship between the size of the instrument and the diameter of the external urethral meatus. Starting from the assumption that the clinical results of the bipolar resection should be at least equal to the monopolar resection,5the end point of our study was to analyze with a adequate sample size, 1000 patients, and sufficient follow-up, at least 6 months, whether bipolar resection is safe particularly looking into the incidence of TUR syndrome, bladder neck contracture, urethral strictures, blood loss, and unwanted stimulation of the obturator reflex.

TURP

Criteria of inclusion for patients undergoing TURP. Diag-nosis of benign prostatic hypertrophy–induced obstruction, prostatic volume between 20 and 80 mL, International Pros-tate Symptom Score (IPSS)>13, and maximum urinary flow (Qmax)<10 mL=second.

End points. Median resection time, median amount of

resected tissue, median hemoglobin difference between the preoperative values and the values of the second postopera-tive day, average catheterization time, average hospital stay, incidence of TUR syndrome, incidence of bladder neck con-tracture or urethral strictures, number of postoperative vesical tamponade, number of patients requiring blood transfusions, number of patients with unachieved obstructive clearance (Qmax<15 mL=second), and change in preoperative respect to postoperative prostate-specific antigen (PSA), IPSS, and Qmax.

Follow-up. Physical examination (including digital rectal examination), PSA, IPSS, uroflowmetry, and cystoscopy were routinely performed at 6 and 12 months and then yearly.

TURB

Criteria of inclusion for patients undergoing TURB.

Echographic=endoscopic evidence of intravesical lesions. Pa-tients submitted to radical cystectomy within 6 months from the procedure were not included in the present analysis.

End points. Median resection time, median hemoglobin

difference between the preoperative values and the values of

the second postoperative day, triggering of the obturator nerve, incidence of urethral strictures, occurrence of urinary retention–induced through blood clots, and number of pa-tients requiring blood transfusions.

Follow-up of low-grade neoplasms. Cystoscopy was

rou-tinely performed the third and the ninth month after TURB and then yearly.

Follow-up of high-grade or highly recurrent neoplasms.

Urinary cytology and cystoscopy were performed every 3 months the first year and every 6 months thereafter. In-travenous urography or CT scan was performed yearly.

TUIP

Criteria for inclusion for patients undergoing TUIP. Sym-ptomatic bladder neck obstruction in patients with a prostatic volume of less than 25 mL and without middle lobe.

End points. Median procedure time, median hemoglobin

difference between the preoperative values and the values of the second postoperative day, median catheterization time, median hospital stay, incidence of urethral or bladder neck strictures, and number of patients who had a Qmax<15 mL= second after 6 months.

Follow-up. Physical examination (including digital rectal examination), PSA, IPSS, uroflowmetry, and cystoscopy were routinely performed at 6 and 12 months and then yearly.

Equipment

The Olympus TURis @ SurgMaster UES–40 electrosurgical unit generates a high-frequency alternating current from the electrode inside the resectoscope. The entire resectoscope ex-Table1. Characteristics of Patients Submitted to Transurethral Resection of Prostate

No. of patients

Median age (range)

Median PSA (range)

Median IPSS (range)

Median Qmax (range)

Median prostate volume (range)

376 66.5 (47–86) years 3.2 (0.12–18.7) ng=mL 24 (13–35) 6 mL=second (0–10) 52 mL (20–80)

PSA¼prostate specific antigen; IPSS¼International Prostate Symptom Score; Qmax¼maximum urinary flow.

Table2. Characteristics of Patients Submitted to Transurethral Resection of Bladder Neoplasm

No. of patients

Median age (range)

No. of men (%)= no. of women (%)

No. (%) of lesions greater than 3 cm

No. (%) of multifocal lesions

No. (%) of cases with at least one lesion

of the lateral wall

480 64 (32–88) years 393 (82)=87 (18) 67 (14) 201 (42) 301 (63)

Table3. Characteristics of Patients Submitted to Transurethral Incision of Prostate

No. of patients

Median age (range)

Median Qmax (range)

Median prostate volume (range)

144 34 (29–57)

years

7 (3–10) mL=second

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cluding the loop of the electrode is used as return electrode in conductive fluid. The UES 40 supplies 6 forms of monopolar waveforms and 4 bipolar (two for the cutting mode and two for the coagulation mode). The resistive charge in the bipolar function is about 100 Ohm, and the output power can be regulated in steps of 1.2 and 5 W to ensure the necessary precision. A conductive irrigation solution as, for example, physiologic saline is necessary for creation of plasma at the loop electrode.

The setting used for cutting and coagulation was 280 W, respectively, 120 W to allow for ignition of the plasma. Im-mediately thereafter, the generator will downregulate the wattage to the necessary level to allow for reliable mainte-nance of the plasma. The UES-40 HF-unit is able to supply both monopolar and bipolar current. The resectoscope used was an Olympus 26F in continuous flow–type Iglesias with continuous aspiration. The loop electrodes were all disposable=single use.

Results

The median follow-up of the entire cohort was 12 months (range, 6–24 months); 663 patients had at least 1-year follow-up (66.3%). None of the patients operated experienced a TUR syndrome or a thermal skin lesion. Urethral stricture occurred in 27 patients (2.7%). The stricture was bulbar in 26=27 cases and localized at the external urethral meatus in 1 case. Four patients developed a bladder neck contracture after TURP (1%). Early postoperative clot retention occurred in 21 patients (2.1%), and 11 patients needed one or more transfusion (1.1%). Only 6 patients out of 301 submitted to TUR of a neoplastic lesions at the lateral bladder wall experienced an unwanted trigger of the obturator reflex (2%). The profiles of the patients and the pathology treated are illustrated in tables (Tables 1–3).

TURP results

Median preoperative PSA, IPSS, and Qmax values were, respectively, 3.2 ng=mL, 24 mL=second, and 6 mL=second. Median postoperative values were, respectively, 0.6 ng=mL, 5 mL=second, and 19 mL=second (Tables 4–6). The median resection time was 42 minutes. The median amount of re-sected tissue was 24.6 mL. The median hemoglobin decline was 0.8 g=dL. The median catheterization time was about 3 days, whereas the median hospital stay was 4 days. About 4 patients (1%) developed a bladder neck contracture, whereas urethral stricture occurred in 11 patients (2.9%). Early postoperative clot retention occurred in 11 patients (2.9%). Seven patients (1.8%) required a blood transfusion of up to 2 units of erythrocyte concentrate. Overall, 17=376 (4.5%) had a Qmax<15 mL=second after 6 months.

TURB results

The median resection time was 27 minutes (Tables 7 and 8). A median of 3 mL of tissue was resected. The median drop in

hemoglobin was 0.7 g=dL. The involuntary stimulation of the obturator nerve occurred overall in 6 patients out of 301 with a neoplastic lesion of the lateral wall (2%). Urethral strictures occurred in 12 patients (2.5%). About 10 patients (2%) expe-rienced postoperative clot retention. Four patients (0.8%) required blood transfusions of up to 2 units of erythrocyte concentrate.

TUIP results

The median time for performing a TUIP was 23 minutes (Table 9). There was no measurable postoperative hemoglo-bin decline. Only two urethral strictures (1.3%) were recorded. No bladder neck contracture occurred. The median catheter-ization time was 1 day. The median hospital stay was 2 days. Only two patients (1.3%) had a Qmax <15 mL=second at 6 months after the procedure.>

Discussion

The clinical efficiency and safety profile of monopolar TUR has notably improved over the years. Any technique that today aspires to become an alternative to TUR must be able to offer the patient the same results by reducing the risks asso-ciated with the use of the monopolar device (thermal lesions and faradic effect) and equally with the use of electrolyte-free irrigation solution (TUR syndrome). Starting from these as-sumptions, several resectoscopes equipped with a bipolar resection technology were developed.

Bipolar resection is theoretically safer because it excludes the patient from the electrical circuit and uses a physiological solution as an irrigant. The phase III comparative studies (monopolar vs. bipolar) demonstrated that both technologies have similar clinical results,5–7but the bipolar device showed to have less intra—and postoperative complications resulting in a greater safety of use as, for example, the absence of TUR syndrome. Further, it was stated that the bipolar technology appears to be more cost effective at the investigating insti-tution, with savings peaking at $1200.5It must be emphasized that these papers are not directly comparable because of the different devices that have been used (PKÒ

system from GyrusÒ

[Maple Grove, MN] and the TURisÒ

system from OlympusÒ

[Tokyo, Japan]). In a recent review of the literature Ho and Cheng8 observed that in the majority of published papers the patients were treated with the PK system by Table4. Transurethral Resection of Prostate Operative Characteristics

No. of

Table5. Complications Related to Transurethral Resection of Prostate

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Gyrus. Ho reports that this technology is capable of supply-ing identical clinical results to monopolar TUR in terms of resection time, bleeding, duration of catheterization, and hospital stay but with a greater rate of urethral strictures (6%). The author concludes by defining bipolar resection as being safer compared to monopolar (absence of TUR syn-drome, slightly less blood loss, and absence of thermal le-sions), while being economically disadvantageous (about 300 US dollars) and burdened with a greater incidence of urethral strictures (6%). The same author9published the results of a randomized study over 100 patients treated with an Olympus high-frequency generator, whereby 52 patients underwent resection with a monopolar technique and 48 with a bipolar technique. In this case too the differences in terms of bleeding, intervention duration, catheterization, hospital stay, and in-cidence of TUR syndrome were not statistically significant but with a notable reduction in costs in favor of the Olympus system (TURis 60 US dollars vs. PK 300 US dollars). However, Ho describes a greater incidence of urethral strictures in the group of patients operated with the bipolar device TURis, 3=48 patients in the monopolar group versus 1=52 submitted to the bipolar resection, although these results did not reach statistical significance. The problem of pathogenesis of ure-thral strictures was discussed in an editorial by Oliver Reich.10He postulates that the increased electrical density on the outer sheath of the resectoscope and any small damage on the surface of the outer sheath can cause dispersions of flow

on the urethral mucosa. He also emphasizes that in the TURis system, as opposed to the Gyrus system, the outer sheath of the resectoscope acts as return electrode, and thus theoreti-cally this could lead to an increased risk of urethral lesions. However, in the Ho’s paper it is reported that a careful check of each resectoscope used for the study did not reveal any damage. Any electrosurgical device has the so-called dis-persion flow, which according to directive IEC60601-2–2 for medical devices to be safe must be less than 150 mA. All sit-uations responsible for an increase in the impedance of the circuit or a defect in insulation cause an increase in the dis-persion flow with possible thermal-induced lesions in the urethral mucosa. The use of conductive lubricants can in-crease this risk. Morishita et al.11have shown that the main cause of the increase in resistance in a circuit is the multiuse of loops (officially single use) and have calculated that the threshold of 100 mA is reached after the third use by the bi-polar loop and after the first use with the monobi-polar device. Returning to the technical data supplied by Olympus, we observe that in the TURis case in question there is a disper-sion flow in optimal conditions of about 6–7 mA and in ab-normal conditions (multiuse) of about 50 mA, and hence 20=25 times below the limit in normal conditions and 3 times below in abnormal conditions (multiuse). Accordingly, we decided to use a new loop for each resection.

Our study represents the only currently available published data using the Olympus TURis bipolar resectoscope on a lar-ger cohort of patients (376 TURP, 144 TUIP, and 480 TURB) with a follow-up of at least 6 months. In our series bipolar resection appears to be a safe procedure. In none of the 1000 cases there was any TUR syndrome, while the incidence was 1.4% in one of the largest series of monopolar TURP.4 More-over, bipolar resection provides unremarkable clinical results in terms of duration of intervention, peri- and postoperative bleeding, catheterization, and hospital stay time. The higher Table6. Transurethral Resection of Prostate Outcome

No. of patients

Median PSA (range)

Median Q max (range)

Median IPSS (range)

No. of patients with a Qmax<15 mL=second

at 6 months

376 0.6 (0.07–9.3) ng=mL 19 (6–39) mL=second 5 (0–25) 17 (4.5%)

Table7. Transurethral Resection of Bladder Neoplasm Operative Characteristics

No. of patients

Median resection time (range)

Median decline in postoperative Hb (range)

Median weight of the resected

tissue (range)

Obturator nerve stimulation

480 27 (5–82) min 0.7 (0–6) g=dL 3 (1–36) mL 6 (2%)

Table9. Transurethral Incision of Prostate Operative Characteristics, Complications, and Outcome

No. of patients

Median surgery time (range)

Median decline in postoperative Hb

Median catheterization time (range)

Median hospital stay (range)

No. of urethral patients with a stricture

Qmax<15 mL=second at 6 months

144 23 (15–32) min – 1 (1–7) 2 (2–9) 2 (1.3%)

Table8. Complications Related to Transurethral Resection of Bladder Neoplasm

No. of patients

Urethral stricture

Blood clot

retention Transfusion

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current flow in the TURis device was not associated in our series with a greater incidence of urethral strictures compared to the literature data obtained with monopolar devices. The main reason is probably that we used a new loop for each intervention. Another reason could be that the median resec-tion time, related to TURP, was sensibly less, 42 minutes, compared to what reported by Ho et al.,959 minutes. More-over, a urethrotomy was routinely performed before intro-duction of the resectoscope to prevent stricture of the external meatus when there was an inappropriate relationship between the size of the instrument and the diameter of the urethral meatus. Our recorded incidence of stricture was, respectively, 2.9% for TURP and 1.3% for TUIP, while monopolar TURP and TUIP stricture incidence is, respectively, about 3.8% and 1.7% in literature.12–14The incidence of bladder neck contrac-ture after TURP was 1% in our series, whereas in literacontrac-ture an incidence of 4% is reported after TURP and 0.4% after TUIP.12–14Concerning the unwanted stimulation of the obtu-rator nerve during a TURB procedure, it was recorded in six cases with a neoplastic lesion of the lateral wall (2%). We actually doubt that the problem of the unwanted triggering of the obturator nerve could be totally solved by the use of bi-polar devices as the dispersion current is transmitted into the bladder wall for several millimeters, especially in women and young subjects with a reduced wall thickness.

Conclusions

Resection with bipolar technology (TURis) offers the pa-tient the same results as monopolar technology, still consid-ered today the gold standard for endoscopic surgery of the lower urinary tract, guaranteeing maximum safety without increasing the incidence of urethral strictures. Single use of the loop electrode, at least in longer procedure as TURP, is strongly advisable.

Acknowledgment

This work was conducted with contributions from Olym-pus, Italy, which kindly donated the Olympus TURis Surg-Master UES–40 electrosurgical unit.

Disclosure Statement

No competing financial interests exist.

References

1. Crowley AR, Horowitz M, Chan E, et al. Transurethral re-section of the prostate versus open prostatectomy: Long-term mortality comparison. J Urol 1995;153:695–697. 2. Rassweiler J, Teber D, Kuntz R, et al. Complications of

transurethral resection of the prostate (TURP)—incidence, management, and prevention. Eur Urol 2006;50:969–979. 3. Reich O, Gratzke C, Stief CG. Techniques and long-term

results of surgical procedures for BPH. Eur Urol 2006;49: 970–978.

4. Reich O, Gratzke C, Bachmann A, et al. Morbidity, mortality and early outcome of transurethral resection of the prostate: A prospective multicenter evaluation of 10,654 patients. J Urol 2008;180:246–249.

5. Starkman JS, Santucci RA. Comparison of bipolar transure-thral resection of the prostate with standard transuretransure-thral prostatectomy: Shorter stay, earlier catheter removal and fewer complications. BJU Int 2005;95:69–71.

6. Singh H, Desai MR, Shrivastav P, et al. Bipolar versus monopolar transurethral resection of prostate: Randomized controlled study. J Endourol 2005;19:333–338.

7. Dunsmuir WD, McFarlane JP, Tan A, et al. Gyrus bipolar electrovaporization vs. transurethral resection of the pros-tate: A randomized prospective single-blind trial with 1 y follow-up. Prostate Cancer Prostatic Dis 2003;6:182–186. 8. Ho HS, Cheng CW. Bipolar transurethral resection of prostate:

A new reference standard? Curr Opin Urol 2008;18:50–55. 9. Ho HS, Yip SK, Lim KB, et al. A prospective randomized

study comparing monopolar and bipolar transurethral re-section of prostate using transurethral rere-section in saline (TURIS) system. Eur Urol 2007;52:517–522.

10. Reich O. Editorial comment on: A prospective randomized study comparing monopolar and bipolar transurethral re-section of prostate using transurethral rere-section in saline (TURIS) system. Eur Urol 2007;52:523–524.

11. Morishita H, Nakajima Y, Chen X, et al. Electrical resistance and current leakage of appliances for resection. Hinyokika Kiyo 1992;38:413–417.

12. Wasson JH, Reda DJ, Bruskewitz RC, et al. A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. The Veterans Affairs Cooperative Study Group on Transurethral Resec-tion of the Prostate. N Engl J Med 1995;332:75–79.

13. Yang Q, Peters TJ, Donovan JL, et al. Transurethral incision compared with transurethral resection of the prostate for bladder outlet obstruction: A systematic review and meta-analysis of randomised controlled trials. J Urol 2001;165: 1526–1532.

14. Tkocz M, Prajsner A. Comparison of long-term results of transurethral incision of the prostate with transurethral re-section of the prostate, in patients with benign prostatic hypertrophy. Neurourol Urodyn 2002;21:112–116.

Address reprint requests to: Angelo Naselli, M.D. Urology Unit National Institute for Cancer Research Largo Rosanna Benzi 10 Genoa 16132 Italy

E-mail:angelo.naselli@libero.it angelo.naselli@auro.it

Abbreviations Used PSA¼prostate specific antigen

IPSS¼International Prostate Symptom Score

Qmax¼maximum urinary flow

TUIP¼transurethral incision of prostate

TUR¼transurethral resection

TURB¼transurethral resection of bladder neoplasm

TURis¼bipolar transurethral resection in saline

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