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Transurethral Bipolar Enucleation of the Prostate Is an Effective Treatment Option for Men With Urinary Retention
Accepted Manuscript Title: Transurethral Bipolar Enucleation of the Prostate is an Effective Treatment Option for Men with Urinary Retention Author: James M Tracey, Jonathan N Warner PII: DOI: Reference:
S0090-4295(15)00960-7 http://dx.doi.org/doi: 10.1016/j.urology.2015.10.011 URL 19440
To appear in:
Urology
Received date: Accepted date:
21-6-2015 5-10-2015
Please cite this article as: James M Tracey, Jonathan N Warner, Transurethral Bipolar Enucleation of the Prostate is an Effective Treatment Option for Men with Urinary Retention, Urology (2015), http://dx.doi.org/doi: 10.1016/j.urology.2015.10.011. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Transurethral Bipolar Enucleation of the Prostate is an Effective Treatment Option for Men with Urinary Retention
James M Tracey*a Jonathan N Warnera *Corresponding author a
University of Michigan Hospitals Department of Urology
1500 East medical Center Drive Ann Arbor, MI 48109 [email protected] 608-772-0949 Key Words: BPH, enucleation, prostate, bipolar, holmium, retention Word Count: 1) Abstract – 243
2) Body of Revised Paper – 2,998
Black and White Print is Sufficient Running Header: TuBE for urinary retention Acknowledgements: Conflicts of Interest: None for Either Author Financial Disclosures: None for Either Author Non-Financial Support: The Ann Arbor Veteran’s Administration Hospital and the University of Michigan Hospital supported this work with IRB approval and employment during the time the study was conducted.
Abbreviations: Benign prostatic hyperplasia (BPH) Transurethral Bipolar Enucleation (TuBE)
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Open Simple Prostatectomy (OP) Plasmakinetic Enucleation of the prostate (PkEP) Bipolar Plasma Enucleation of the prostate (BPEP) Holmium Laser Enucleation of the prostate (HoLEP) Abstract: Objective: To evaluate outcomes of transurethral bipolar enucleation (TuBE) of the prostate on patients with refractory lower urinary tract symptoms. Methods: A retrospective analysis was performed on patients undergoing TuBE from July 2014 to March 2015. Perioperative factors evaluated included international prostate symptom score (IPSS), sexual health inventory men (SHIM), prostate specific antigen (PSA), post void residual volume (PVR), trans rectal ultrasound volume measurement, estimated blood loss, operative time, pathologic weight, and complications. Postoperative evaluation was performed at 6 weeks and 3 months. Results: 49 patients were identified. Mean age was 67 years old, mean follow up was 4.4 months. 28 patients (57%) were in retention. Preoperative, 6 week and 3 month mean PVR was 278 ml, 66 ml and 87 ml (p <0.01); mean IPSS was 22, 9 and 8 (p <0.01); mean QOL was 5.0, 1.9 and 1.9; and SHIM was 7.1, 8.4 and 7.0 (p =0.35) respectively. 28 patients (57%) were able to have erections preoperatively and were still able to postoperatively. All (100%) of patients in retention were able to void postoperatively. Mean operative time was 93 minutes, EBL was 49 ml, and pathologic weight was 18 grams. Urinary tract infection occurred in 3 patients (6%),
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urethral stricture in one (2%) and bladder neck contracture in 2 (4%). Mean PSA decreased from 3.2 ng/dL to 0.9 ng/dL at 3 months (P < 0.01). Conclusions: TuBE is an effective operation for refractory urinary tract symptoms including those in urinary retention.
Introduction: Transurethral resection of the prostate (TURP) and open simple prostatectomy (OP) have historically been the gold standards for surgical treatment of benign prostatic hyperplasia (BPH) for small and large glands, respectively. They continue to be mainstays in treatment as evidenced by both the AUA and European Urology’s most recent BPH guidelines1,2. However, holmium laser enucleation of the prostate (HoLEP) is gaining acceptance as the new gold standard operation for BPH and LUTS3, 4. HoLEP has been shown to be superior peri-operatively when compared to OP in regards to transfusion rates, hospitalization time and catheterization time5. It also produces equal to improved functional outcomes with longer durability than TURP, transurethral vaporization of the prostate (TUVP), and photovaporization of the prostate (PVP)5, 6-11. HoLEP offers the advantage of a single operation for large prostates 12. Despite the clear benefits of HoLEP, it has not gained wide spread utilization likely secondary to a steep learning curve, inability to convert easily to a conventional resection, and the added expense of the morcellation device and high energy holmium laser1, 4, 10 . Thus, the international urologic community has sought various approaches and equipment that can be used to enucleate the prostate with the hope of producing similar 3 Page 3 of 21
efficacy as enucleating with the holmium laser. Continuous fire thulium lasers have been developed to allow better vaporization of tissue while performing laser enucleation13,14 . They appear promising, but may not produce a cost reduction given the need to purchase a thulium laser which has limited utility outside of the prostate. Transurethral bipolar enucleation techniques were first reported in 200615. There have been two separate techniques described that are common in that the energy source utilized is bipolar electrocautery and the majority of the enucleation is performed bluntly using the tip of the resectoscope. Plasmakinetic enucleation of the prostate (PkEP) utilizes bipolar electrocautery with a loop instrument while bipolar plasma enucleation of the prostate (BPEP) uses a button electrode for enucleation15-19. Thus, regardless of electrode being used a transurethral bipolar enucleation of the prostate (TuBE) is being performed. Techniques for addressing enucleated prostate tissue vary. Two groups describe leaving the prostate attached at the bladder neck as a loop electrode is used to resect the enucleated tissue relatively bloodlessly17, 20. The remaining groups report use of traditional morcellation devices after the adenoma has been released off of the prostatic bed. This study reports a single surgeon’s early experience with transurethral bipolar enucleation with loop resection. Particular attention will be paid to those patients in retention. We hypothesize that the outcomes of TuBE will be comparable to those reported with other enucleation procedures. Materials and Methods:
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A retrospective review of an IRB approved database was performed on 49 consecutive patients who had undergone a TuBE. Indications included medical refractory LUTS, contraindications to oral therapy, or complications of an enlarged prostate including retention, bladder stones, recurrent hematuria and recurrent urinary tract infections. Preoperative parameters evaluated include age, prostate specific antigen (PSA), international prostate symptom score (IPSS), IPSS quality of life score (QOL), sexual health inventory for men (SHIM), trans rectal ultrasound volume study of the prostate, history of prostate biopsy or prior prostate surgery, and post void residual volume (PVR). These parameters were reassessed at 6 weeks and 3 months. Urodynamic testing was sometimes performed in younger patients, those with small prostates, in urinary retention, or those with diabetes or neurologic conditions. However, urodynamics was not often included preoperatively, and is thought to be largely unnecessary by the authors. Urine culture was tested preoperatively. If urine culture was positive, infection was treated and urine was retested prior to surgery. Surgical approach After informed consent was obtained, all patients received preoperative antibiotics, and underwent general anesthesia. The surgical procedure has been previously described 20 using a 27 French OES Pro Resectoscope (Olympus America Incorporate, USA). The Plasmabutton (Olympus America Incorporated, USA) was used to enucleate the prostate. During enucleation, a bridge of mucosa was left attached at the bladder neck and apex to stabilize the prostate during resection, which was completed with a fine loop electrode. 5 Page 5 of 21
Postoperative management Patients received a 22 French two-way catheter and were admitted for observation overnight. The catheter was placed on light traction for 4 hours postoperatively and then removed on postoperative day 1. Patients were instructed to void twice prior to discharge to ensure low PVRs. If there were intraoperative concerns for prostate capsule perforation or undermining of the bladder neck, the patient would be discharged with a catheter in place and would be instructed to follow up in 2-5 days, depending on clinic schedule, for catheter removal. If a patient was unable to void after catheter removal then a 16 French catheter was replaced, and the patient was discharged with instruction to follow up in 2-5 days for catheter removal. Patients were followed at 6 week and 3 month intervals. At each visit PVR, flow rate, IPSS and SHIM scores were assessed. At 3 month visits, PSA was also assessed. If PSA was appropriate and symptoms were resolved then patients were discharged from clinic. Persistent irritative symptoms such as urgency and frequency were treated first with a course of anticholinergics. If the symptoms remained severe and bothersome, then onabotulinum toxin was offered. If PVR was elevated, or increasing from 6 weeks to 3 months, a cystoscopy was performed to rule out a bladder neck contracture or urethral stricture. Statistical analysis Continuous variables were evaluated with the student t-test. One-way analysis of variance was utilized to test the difference between preoperative continuous variables and the
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6 week and 3 month variables. A two-tailed p value less than 0.05 was considered significant. Statistical analysis was performed using SPSS version 21 (IBM, New York). Results: Preoperative 49 consecutive patients underwent TuBE from July 2014 to March 2015. Mean follow up was 4.4 months (range 1.2 to 10.7). All 49 patients (100%) had a minimum of 6 weeks follow up. 32 patients (65%) completed the 3 month follow up. Preoperative factors can be seen in Table 1. 9 patients had preoperative urodynamics performed. Bladder outlet obstruction was diagnosed in 7, while 2 patients suffered acontractile bladder. 40 patients had prostates less than 80 grams, and 9 patients had prostates greater than 80 grams. Operative findings and operative complications. Operative findings can be seen in Table 2. Operative and postoperative complications can be seen in Table 3. There were no grade IV Clavien complications. There were no transfusions, or returns to the operative room for bleeding complications. 4 patients were found to have capsular perforations or bladder neck undermining requiring prolonged catheterization. One patient developed a meatal stenosis requiring dilation then a definitive urethroplasty. Two patients developed a bladder neck contracture. Neither was less than 20 French. However, due to persistent symptoms (urinary retention in one, and persistent overactive bladder in the other), a bladder neck incision was performed ultimately resolving the symptoms.
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The 40 patients with prostates <80 grams had an average operative time of 73 minutes (31-150), while those >80 grams had an average operative time of 163 minutes (108-301) (p <0.01). There was a significant difference in EBL 26ml (5-100) versus 127ml (50-300) for <80g, and >80g, respectively (p <0.01). 35 patients (71%) were able to void the morning after the procedure, 4 patients (8%) required prolonged catheterization due to prostate capsule violation, and 10 patients (20%) were unable to void on postoperative day one, and a catheter was replaced. Postoperative outcomes Comparative analysis between preoperative IPSS score, QOL score, SHIM, PVR and PSA can be seen in Table 4. At 6 weeks, all 28 patients (100%) who were able to achieve erections preoperatively, maintained their erectile function. There was no difference in the SHIM score pre or postoperatively for any of these men, 10.5 (1-25) versus 10.8 (1-25) respectively. Not all of these men were sexually active. At the 6 week follow up, 6 men experienced stress urinary incontinence (12%), only one requiring pads. This same patient was the only one still leaking and requiring pads at 3 months (2%). At the 6 week follow up, 9 patients experienced some degree of urge urinary incontinence (18%). Of these, it was clinically significant requiring treatment in 3 (6%). One patient ultimately went on to receive 100 units of onabotulinum toxin, and was cured by 6 months without need for further onabotulinum toxin as of yet (10 month follow up). One was found to have a bladder neck contracture at three months that was cured by incision of the
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bladder neck contracture. The remaining patients were treated with anticholinergic medication successfully. No patients were in retention at the 6 week follow up. Two patients did have residuals of 300 ml with voided volumes over 500 ml, and they were asymptomatic. At 3 months, one patient developed new retention and underwent cystoscopy which demonstrated a wide bore bladder neck contracture. The contracture was incised, and the patient had a PVR of 200 ml at his last follow up. Both patients with diagnosed acontractile bladder on preoperative urodynamics were able to void postoperatively, as were the 7 patients with bladder outlet obstruction. Preoperatively, only 5 patients had adequate flow testing. Average flow was 7.2 ml/sec (range 2-14ml/sec). Postoperatively at 6 weeks, 15 patients had completed an adequate flow study. The average at 6 weeks was 24.8ml/sec (7-50ml/sec) (p value of the difference <0.01). Comment: Key findings: 1. Statistically significant improvements were seen in IPSS score, QOL score, and PVR in all prostate sizes. 2. All patients who were in retention preoperatively were able to void postoperatively. 3. There appears to be no effect on erectile function. 4. Complications appear to be comparable to other enucleation procedures. Outcomes
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To our knowledge, this is the largest American series of TuBE. This and other reports demonstrate success of the TuBE techniques15-19. Initial randomized controlled trials comparing PkEP and BPEP to OSP, TURP and HoLEP have been reported 15-19. In comparison to TURP, operative times were similar, while drop in hemoglobin, postoperative irrigation time required, catheterization time, hospital stay, amount of resected tissue, IPSS and QOL scores, maximum flow rates, as well as urodynamic unobstructed rates were all in favor of TuBE17. In comparison to OP for prostates greater than 80 grams, BPEP offered equivalent operative time and resected tissue weight but substantially decreased postoperative hemoglobin drop, hematuria rate, catheterization time and hospital stay18, 19. In comparison to TURP and TUVP, TuBE techniques had a shorter operative time and a lower mean PSA level post-operatively, while TUVP had significantly less change in maximum flow rate18. Otherwise, OP, TURP, TUVP and TuBE had similar IPSS score, QOL, and PVR improvements18,19. TuBE versus HoLEP was examined in a series of 40 patients17. Significant differences favoring HoLEP in operative time, recovery room time, and events of bladder irrigation required were identified. However, transfusion rates, catheterization times, hospitalization times, IPSS reduction and maximum flow rate improvement were not different between the two approaches. In the present study, statistically significant changes in IPSS score (22.2 versus 9.0 and 8.0), IPSS QOL score (4.6 versus 1.9 and 1.9), and PVR volumes (278ml versus 66ml and 87ml) were found from preoperative, 6 week and 3 month time courses respectively. Retention
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All patients that were in retention at the beginning of the procedure were no longer in retention by 6 weeks. One patient re-developed retention by 3 months and was treated successfully for a bladder neck contracture. This is the first report that looks specifically at this issue with TuBE. Retention has previously been evaluated with HoLEP21, 22. In these series, similar success was noted both in retention and acontractile bladder. The outcomes of patients with retention receiving enucleation procedures is likely reflective of the significant reduction in outlet resistance given the completeness of the removal of prostatic adenoma. Because of the outcomes reported with HoLEP, the routine use of urodynamics was not performed in our series. In those patients that did have urodynamics- neither bladder outlet obstruction nor acontractile bladder were predictive of failure of the procedure. Erectile Function There appears to be no effect on erectile function. In our series, 100% of men with preoperative erections were able to achieve erections postoperatively. Similar erectile function preservation results have been reported with PkEP17. Frieben et al23 examined erectile dysfunction rates after HoLEP in randomized control trials, and found a 7.5% reported rate of erectile dysfunction with HoLEP. There is conflicting data regarding the depth of coagulation and thermal injury with bipolar devices. The depth of coagulation has been reported at 0.14mm with the bipolar resection loop24 and the button electrode has been reported to be as high as 2.4mm25. Meanwhile, the depth of penetration for holmium laser is reported at 0.44mm26. The probable reason we do not see an impact on erectile function is due to the fact that the majority of the operation is performed bluntly using the tip of the resection loop, and
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only focal pin point electrocautery is used to coagulate bleeding vessels. With more patient recruitment, we may see higher rates of erectile dysfunction similar to those reported with HoLEP. Complications Complications in the present series are comparable to other enucleation procedures. There were no perioperative clot retention or bleeding episodes requiring return to the operating room. There were no blood transfusions, which is consistent with the approximately 1% or less rate reported for BPEP, PkEP and HoLEP 7, 17, 19. Also, postoperative complications of BNC (4%) and urethral stricture (2%) appear to be expected given the published enucleation data 7, 8, 17, 19. A 6% UTI rate is slightly higher than those of other TuBE reports of 2-3%17, 19, but the overall numbers are small. Also, capsular perforation or undermining of the bladder neck occurred in 8% of patients in our study. We believe this rate reflects our learning curve and with experience will decrease. Initial experiences with HoLEP produced similar rates of capsular perforation27. Finally, our experience with post-operative stress and urge incontinence rates being the highest shortly after surgery and then, ultimately, decrease to around 2% are in line with both medium and long-term reports on various enucleation modalities7, 8, 17, 19. Limitations Beyond the retrospective, non-comparative nature of this review, there is no long-term follow up. In addition, a relative limitation is the size of the prostates in the present study. While larger glands can be enucleated using the bipolar technique, most of our prostates were less than 80 grams limiting direct comparison to the large prostate HoLEP data. Average 12 Page 12 of 21
prostate size is 50 grams in the present series and closer to 100 grams in a large HoLEP series by Krambeck et al7. The limitations of the procedure should also be addressed. In the presented study it appears TuBE procedures produce longer operative times. However, all but 3 outliers were
<150minutes and our operative time decreased by an average of 13 minutes between our first 20 procedures and the last 20 even though prostate size was equal reflecting our learning curve. Thus, while enucleation times are likely similar to those for HoLEP, resection versus morcellation times are likely not equal. No reports have compared morcellation versus postenucleation resection directly. Reported morcellation times are up to 5.5-7 g/min28. Therefore, to keep operative times appropriate, large glands, in the present study 168 grams and in prior reports 158 grams17, should likely not be attempted via TuBE without the use of morcellation devices. However, morcellation can still be performed after the tissue is completely enucleated via TuBE similar to a HoLEP. Advantages With these limitations in mind it is important to emphasize the advantages. First, as most urologists are well versed with resectoscopes given the large number of TURP and transurethral resection of bladder tumors performed during training, comfort with the approach is higher than that for laser enucleation devices. Having the ability to easily convert to traditional TURP during the process of learning the TuBE is a clear advantage over laser enucleation. One study evaluated the learning curve and identified PkEP required 30 operations until few conversions to conventional bipolar TURP occurred, and at 50 operations a 13 Page 13 of 21
stable surgical efficiency, as measured by ml/minute of tissue enucleated and resected, was noted29. In addition, anecdotal and personal experience has shown that laser enucleation is performed with the tip of the scope very near the tissue, limiting the global view of the capsular plane. Whereas, the added ability to manipulate the loop or button in and out of the working element of the resectoscope adds in the overall perspective, making the planes easier to visualize during enucleation. TuBE requires a bipolar energy source and resectoscope that are already widely used for other urologic procedures making them a vital part of any general urologic practice. Holmium lasers do have the added benefit of being utilized for stone treatment and will also be part of most urologists’ armamentarium. However, thulium and green light lasers have limited utility outside of BPH treatment. Another advantage of TuBE, even for large prostates up to approximately 170 grams, is the fact that no additional or specialized equipment is required. However, for glands larger than 170 grams options include: a staged approach, performing TuBE or laser enucleation with the aid of a morcellation device, or performing an open or robotic simple prostatectomy. Lastly, the present study indicates that TuBE can be used for small prostates with appropriate outcomes. This is a conclusion that has been established in the holmium laser enucleation literature for some time, though remains controversial 30. Conclusion. TuBE is an effective operation with similar outcomes to other enucleation procedures for prostate glands less than 170 grams. TuBE is effective in patients in retention, has no
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apparent effect on erectile function, and has comparable complication rates to other transurethral procedures.
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Fayad AS, Sheikh MG, Zakaria T, Elfottoh HA, Alsergany R. Holmium laser enucleation versus bipolar resection of the prostate: a prospective randomized study. Which to choose? Journal of endourology / Endourological Society. 2011;25:1347-1352.
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Pal Singh B, Dhakad U. Re: Holmium laser enucleation versus photoselective vaporization for prostatic adenoma greater than 60 ml: preliminary results of a prospective, randomized clinical trial: H. Elmansy, A. Baazeem, A. Kotb, H. Badawy, E. Riad, A. Emran and M. Elhilali J Urol, 2012;188:216-221. The Journal of urology. 2013;189:774-775.
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Krambeck AE, Handa SE, Lingeman JE. Holmium laser enucleation of the prostate for prostates larger than 175 grams. Journal of endourology / Endourological Society. 2010;24:433-437.
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Zhang F, Shao Q, Herrmann TR, Tian Y, Zhang Y. Thulium laser versus holmium laser transurethral enucleation of the prostate: 18-month follow-up data of a single center. Urology. 2012;79:869-874.
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Tang K, Xu Z, Xia D, et al. Early outcomes of thulium laser versus transurethral resection of the prostate for managing benign prostatic hyperplasia: a systematic review and meta-analysis of comparative studies. Journal of endourology / Endourological Society. 2014;28:65-72.
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Neill MG, Gilling PJ, Kennett KM, et al. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006;68:1020-1024.
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Chen YB, Chen Q, Wang Z, et al. A prospective, randomized clinical trial comparing plasmakinetic resection of the prostate with holmium laser enucleation of the prostate based on a 2-year followup. The Journal of urology. 2013;189:217-222.
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Zhao Z, Zeng G, Zhong W, Mai Z, Zeng S, Tao X. A prospective, randomised trial comparing plasmakinetic enucleation to standard transurethral resection of the prostate for symptomatic benign prostatic hyperplasia: three-year follow-up results. European urology. 2010;58:752-758.
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Geavlete B, Bulai C, Ene C, Checherita I, Geavlete P. Bipolar vaporization, resection, and enucleation versus open prostatectomy: optimal treatment alternatives in large prostate cases? Journal of endourology / Endourological Society. 2015;29:323-331.
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Liao N, Yu J. A study comparing plasmakinetic enucleation with bipolar plasmakinetic resection of the prostate for benign prostatic hyperplasia. Journal of endourology / Endourological Society. 2012;26:884-888.
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Peterson MD, Matlaga BR, Kim SC, et al. Holmium laser enucleation of the prostate for men with urinary retention. The Journal of urology. 2005;174:998-1001; discussion 1001.
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transurethral resection of the prostate. A pilot study on hemostatic capability. Scandinavian journal of urology and nephrology. 2008;42:265-268. 25.
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Table 1. Preoperative factors Patient number
49
Mean Age
67 (54-88)
Mean follow up (months)
4.4 (1.2-10.7)
Patients in retention
28 (57%)
Prostate specific antigen (44 patients)
3.2 (0.1-15.8)
Prior surgical resection
9 patients (18%)
Prior prostate biopsy
10 patients (20%)
Mean PVR (mL)
278 (0-900)
Mean trans rectal ultrasound volume (grams)
50 (11-168)
Mean IPSS
22 (4-35)
Mean QOL score
5 (2-6)
Able to achieve erection
28 patients (57%)
Mean SHIM
7.4 (1-25)
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Table 2. Operative findings American Society of Anesthesiologists Score
2 (1-3)
Operative time
93 minutes (31-301)
Estimated blood loss
49 ml (5-300)
Mean pathology weight
18.0 grams (1.7-100.0)
Cancer diagnosis
3 (6%)
Resected Volume/Preoperative TRUS volume
0.30 (0.05-0.95)
Catheterization time
2 days (1-6)
Hospital stay
1 day (0-2)
Table 3. Complications Grade
Complication
Number
Total for Grade
Clavien I
Postoperative supraventricular tachycardia without intervention
1 (2%)
1
Clavien II
UTI
3 (6%)
7
Perforation or undermining of the bladder resulting in prolonged catheter
4 (8%)
Meatal stricture requiring urethroplasty
1 (2%)
Bladder neck contracture requiring incision
2 (4%)
Clavien III
3
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Table 4. Comparison of pre and postoperative factors. Preoperative
6 week
3 month (32 patients)
P value
IPSS score
22.2 (4-35)
9.0 (1-25)
8.0 (1-27)
<0.01
IPSS QOL
4.6 (2-6)
1.9 (2-6)
1.9 (2-6)
<0.01
SHIM
7.4 (1-25)
8.4 (1-25)
7.04 (1-25)
0.35
PVR
278 (0-900)
66 (0-300)
87 (0-432)
<0.01
PSA
3.2 (0.1-15.8)
Not tested
0.9 (0.06-4.65)
<0.01
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S0090-4295(15)00960-7 http://dx.doi.org/doi: 10.1016/j.urology.2015.10.011 URL 19440
To appear in:
Urology
Received date: Accepted date:
21-6-2015 5-10-2015
Please cite this article as: James M Tracey, Jonathan N Warner, Transurethral Bipolar Enucleation of the Prostate is an Effective Treatment Option for Men with Urinary Retention, Urology (2015), http://dx.doi.org/doi: 10.1016/j.urology.2015.10.011. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Transurethral Bipolar Enucleation of the Prostate is an Effective Treatment Option for Men with Urinary Retention
James M Tracey*a Jonathan N Warnera *Corresponding author a
University of Michigan Hospitals Department of Urology
1500 East medical Center Drive Ann Arbor, MI 48109 [email protected] 608-772-0949 Key Words: BPH, enucleation, prostate, bipolar, holmium, retention Word Count: 1) Abstract – 243
2) Body of Revised Paper – 2,998
Black and White Print is Sufficient Running Header: TuBE for urinary retention Acknowledgements: Conflicts of Interest: None for Either Author Financial Disclosures: None for Either Author Non-Financial Support: The Ann Arbor Veteran’s Administration Hospital and the University of Michigan Hospital supported this work with IRB approval and employment during the time the study was conducted.
Abbreviations: Benign prostatic hyperplasia (BPH) Transurethral Bipolar Enucleation (TuBE)
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Open Simple Prostatectomy (OP) Plasmakinetic Enucleation of the prostate (PkEP) Bipolar Plasma Enucleation of the prostate (BPEP) Holmium Laser Enucleation of the prostate (HoLEP) Abstract: Objective: To evaluate outcomes of transurethral bipolar enucleation (TuBE) of the prostate on patients with refractory lower urinary tract symptoms. Methods: A retrospective analysis was performed on patients undergoing TuBE from July 2014 to March 2015. Perioperative factors evaluated included international prostate symptom score (IPSS), sexual health inventory men (SHIM), prostate specific antigen (PSA), post void residual volume (PVR), trans rectal ultrasound volume measurement, estimated blood loss, operative time, pathologic weight, and complications. Postoperative evaluation was performed at 6 weeks and 3 months. Results: 49 patients were identified. Mean age was 67 years old, mean follow up was 4.4 months. 28 patients (57%) were in retention. Preoperative, 6 week and 3 month mean PVR was 278 ml, 66 ml and 87 ml (p <0.01); mean IPSS was 22, 9 and 8 (p <0.01); mean QOL was 5.0, 1.9 and 1.9; and SHIM was 7.1, 8.4 and 7.0 (p =0.35) respectively. 28 patients (57%) were able to have erections preoperatively and were still able to postoperatively. All (100%) of patients in retention were able to void postoperatively. Mean operative time was 93 minutes, EBL was 49 ml, and pathologic weight was 18 grams. Urinary tract infection occurred in 3 patients (6%),
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urethral stricture in one (2%) and bladder neck contracture in 2 (4%). Mean PSA decreased from 3.2 ng/dL to 0.9 ng/dL at 3 months (P < 0.01). Conclusions: TuBE is an effective operation for refractory urinary tract symptoms including those in urinary retention.
Introduction: Transurethral resection of the prostate (TURP) and open simple prostatectomy (OP) have historically been the gold standards for surgical treatment of benign prostatic hyperplasia (BPH) for small and large glands, respectively. They continue to be mainstays in treatment as evidenced by both the AUA and European Urology’s most recent BPH guidelines1,2. However, holmium laser enucleation of the prostate (HoLEP) is gaining acceptance as the new gold standard operation for BPH and LUTS3, 4. HoLEP has been shown to be superior peri-operatively when compared to OP in regards to transfusion rates, hospitalization time and catheterization time5. It also produces equal to improved functional outcomes with longer durability than TURP, transurethral vaporization of the prostate (TUVP), and photovaporization of the prostate (PVP)5, 6-11. HoLEP offers the advantage of a single operation for large prostates 12. Despite the clear benefits of HoLEP, it has not gained wide spread utilization likely secondary to a steep learning curve, inability to convert easily to a conventional resection, and the added expense of the morcellation device and high energy holmium laser1, 4, 10 . Thus, the international urologic community has sought various approaches and equipment that can be used to enucleate the prostate with the hope of producing similar 3 Page 3 of 21
efficacy as enucleating with the holmium laser. Continuous fire thulium lasers have been developed to allow better vaporization of tissue while performing laser enucleation13,14 . They appear promising, but may not produce a cost reduction given the need to purchase a thulium laser which has limited utility outside of the prostate. Transurethral bipolar enucleation techniques were first reported in 200615. There have been two separate techniques described that are common in that the energy source utilized is bipolar electrocautery and the majority of the enucleation is performed bluntly using the tip of the resectoscope. Plasmakinetic enucleation of the prostate (PkEP) utilizes bipolar electrocautery with a loop instrument while bipolar plasma enucleation of the prostate (BPEP) uses a button electrode for enucleation15-19. Thus, regardless of electrode being used a transurethral bipolar enucleation of the prostate (TuBE) is being performed. Techniques for addressing enucleated prostate tissue vary. Two groups describe leaving the prostate attached at the bladder neck as a loop electrode is used to resect the enucleated tissue relatively bloodlessly17, 20. The remaining groups report use of traditional morcellation devices after the adenoma has been released off of the prostatic bed. This study reports a single surgeon’s early experience with transurethral bipolar enucleation with loop resection. Particular attention will be paid to those patients in retention. We hypothesize that the outcomes of TuBE will be comparable to those reported with other enucleation procedures. Materials and Methods:
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A retrospective review of an IRB approved database was performed on 49 consecutive patients who had undergone a TuBE. Indications included medical refractory LUTS, contraindications to oral therapy, or complications of an enlarged prostate including retention, bladder stones, recurrent hematuria and recurrent urinary tract infections. Preoperative parameters evaluated include age, prostate specific antigen (PSA), international prostate symptom score (IPSS), IPSS quality of life score (QOL), sexual health inventory for men (SHIM), trans rectal ultrasound volume study of the prostate, history of prostate biopsy or prior prostate surgery, and post void residual volume (PVR). These parameters were reassessed at 6 weeks and 3 months. Urodynamic testing was sometimes performed in younger patients, those with small prostates, in urinary retention, or those with diabetes or neurologic conditions. However, urodynamics was not often included preoperatively, and is thought to be largely unnecessary by the authors. Urine culture was tested preoperatively. If urine culture was positive, infection was treated and urine was retested prior to surgery. Surgical approach After informed consent was obtained, all patients received preoperative antibiotics, and underwent general anesthesia. The surgical procedure has been previously described 20 using a 27 French OES Pro Resectoscope (Olympus America Incorporate, USA). The Plasmabutton (Olympus America Incorporated, USA) was used to enucleate the prostate. During enucleation, a bridge of mucosa was left attached at the bladder neck and apex to stabilize the prostate during resection, which was completed with a fine loop electrode. 5 Page 5 of 21
Postoperative management Patients received a 22 French two-way catheter and were admitted for observation overnight. The catheter was placed on light traction for 4 hours postoperatively and then removed on postoperative day 1. Patients were instructed to void twice prior to discharge to ensure low PVRs. If there were intraoperative concerns for prostate capsule perforation or undermining of the bladder neck, the patient would be discharged with a catheter in place and would be instructed to follow up in 2-5 days, depending on clinic schedule, for catheter removal. If a patient was unable to void after catheter removal then a 16 French catheter was replaced, and the patient was discharged with instruction to follow up in 2-5 days for catheter removal. Patients were followed at 6 week and 3 month intervals. At each visit PVR, flow rate, IPSS and SHIM scores were assessed. At 3 month visits, PSA was also assessed. If PSA was appropriate and symptoms were resolved then patients were discharged from clinic. Persistent irritative symptoms such as urgency and frequency were treated first with a course of anticholinergics. If the symptoms remained severe and bothersome, then onabotulinum toxin was offered. If PVR was elevated, or increasing from 6 weeks to 3 months, a cystoscopy was performed to rule out a bladder neck contracture or urethral stricture. Statistical analysis Continuous variables were evaluated with the student t-test. One-way analysis of variance was utilized to test the difference between preoperative continuous variables and the
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6 week and 3 month variables. A two-tailed p value less than 0.05 was considered significant. Statistical analysis was performed using SPSS version 21 (IBM, New York). Results: Preoperative 49 consecutive patients underwent TuBE from July 2014 to March 2015. Mean follow up was 4.4 months (range 1.2 to 10.7). All 49 patients (100%) had a minimum of 6 weeks follow up. 32 patients (65%) completed the 3 month follow up. Preoperative factors can be seen in Table 1. 9 patients had preoperative urodynamics performed. Bladder outlet obstruction was diagnosed in 7, while 2 patients suffered acontractile bladder. 40 patients had prostates less than 80 grams, and 9 patients had prostates greater than 80 grams. Operative findings and operative complications. Operative findings can be seen in Table 2. Operative and postoperative complications can be seen in Table 3. There were no grade IV Clavien complications. There were no transfusions, or returns to the operative room for bleeding complications. 4 patients were found to have capsular perforations or bladder neck undermining requiring prolonged catheterization. One patient developed a meatal stenosis requiring dilation then a definitive urethroplasty. Two patients developed a bladder neck contracture. Neither was less than 20 French. However, due to persistent symptoms (urinary retention in one, and persistent overactive bladder in the other), a bladder neck incision was performed ultimately resolving the symptoms.
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The 40 patients with prostates <80 grams had an average operative time of 73 minutes (31-150), while those >80 grams had an average operative time of 163 minutes (108-301) (p <0.01). There was a significant difference in EBL 26ml (5-100) versus 127ml (50-300) for <80g, and >80g, respectively (p <0.01). 35 patients (71%) were able to void the morning after the procedure, 4 patients (8%) required prolonged catheterization due to prostate capsule violation, and 10 patients (20%) were unable to void on postoperative day one, and a catheter was replaced. Postoperative outcomes Comparative analysis between preoperative IPSS score, QOL score, SHIM, PVR and PSA can be seen in Table 4. At 6 weeks, all 28 patients (100%) who were able to achieve erections preoperatively, maintained their erectile function. There was no difference in the SHIM score pre or postoperatively for any of these men, 10.5 (1-25) versus 10.8 (1-25) respectively. Not all of these men were sexually active. At the 6 week follow up, 6 men experienced stress urinary incontinence (12%), only one requiring pads. This same patient was the only one still leaking and requiring pads at 3 months (2%). At the 6 week follow up, 9 patients experienced some degree of urge urinary incontinence (18%). Of these, it was clinically significant requiring treatment in 3 (6%). One patient ultimately went on to receive 100 units of onabotulinum toxin, and was cured by 6 months without need for further onabotulinum toxin as of yet (10 month follow up). One was found to have a bladder neck contracture at three months that was cured by incision of the
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bladder neck contracture. The remaining patients were treated with anticholinergic medication successfully. No patients were in retention at the 6 week follow up. Two patients did have residuals of 300 ml with voided volumes over 500 ml, and they were asymptomatic. At 3 months, one patient developed new retention and underwent cystoscopy which demonstrated a wide bore bladder neck contracture. The contracture was incised, and the patient had a PVR of 200 ml at his last follow up. Both patients with diagnosed acontractile bladder on preoperative urodynamics were able to void postoperatively, as were the 7 patients with bladder outlet obstruction. Preoperatively, only 5 patients had adequate flow testing. Average flow was 7.2 ml/sec (range 2-14ml/sec). Postoperatively at 6 weeks, 15 patients had completed an adequate flow study. The average at 6 weeks was 24.8ml/sec (7-50ml/sec) (p value of the difference <0.01). Comment: Key findings: 1. Statistically significant improvements were seen in IPSS score, QOL score, and PVR in all prostate sizes. 2. All patients who were in retention preoperatively were able to void postoperatively. 3. There appears to be no effect on erectile function. 4. Complications appear to be comparable to other enucleation procedures. Outcomes
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To our knowledge, this is the largest American series of TuBE. This and other reports demonstrate success of the TuBE techniques15-19. Initial randomized controlled trials comparing PkEP and BPEP to OSP, TURP and HoLEP have been reported 15-19. In comparison to TURP, operative times were similar, while drop in hemoglobin, postoperative irrigation time required, catheterization time, hospital stay, amount of resected tissue, IPSS and QOL scores, maximum flow rates, as well as urodynamic unobstructed rates were all in favor of TuBE17. In comparison to OP for prostates greater than 80 grams, BPEP offered equivalent operative time and resected tissue weight but substantially decreased postoperative hemoglobin drop, hematuria rate, catheterization time and hospital stay18, 19. In comparison to TURP and TUVP, TuBE techniques had a shorter operative time and a lower mean PSA level post-operatively, while TUVP had significantly less change in maximum flow rate18. Otherwise, OP, TURP, TUVP and TuBE had similar IPSS score, QOL, and PVR improvements18,19. TuBE versus HoLEP was examined in a series of 40 patients17. Significant differences favoring HoLEP in operative time, recovery room time, and events of bladder irrigation required were identified. However, transfusion rates, catheterization times, hospitalization times, IPSS reduction and maximum flow rate improvement were not different between the two approaches. In the present study, statistically significant changes in IPSS score (22.2 versus 9.0 and 8.0), IPSS QOL score (4.6 versus 1.9 and 1.9), and PVR volumes (278ml versus 66ml and 87ml) were found from preoperative, 6 week and 3 month time courses respectively. Retention
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All patients that were in retention at the beginning of the procedure were no longer in retention by 6 weeks. One patient re-developed retention by 3 months and was treated successfully for a bladder neck contracture. This is the first report that looks specifically at this issue with TuBE. Retention has previously been evaluated with HoLEP21, 22. In these series, similar success was noted both in retention and acontractile bladder. The outcomes of patients with retention receiving enucleation procedures is likely reflective of the significant reduction in outlet resistance given the completeness of the removal of prostatic adenoma. Because of the outcomes reported with HoLEP, the routine use of urodynamics was not performed in our series. In those patients that did have urodynamics- neither bladder outlet obstruction nor acontractile bladder were predictive of failure of the procedure. Erectile Function There appears to be no effect on erectile function. In our series, 100% of men with preoperative erections were able to achieve erections postoperatively. Similar erectile function preservation results have been reported with PkEP17. Frieben et al23 examined erectile dysfunction rates after HoLEP in randomized control trials, and found a 7.5% reported rate of erectile dysfunction with HoLEP. There is conflicting data regarding the depth of coagulation and thermal injury with bipolar devices. The depth of coagulation has been reported at 0.14mm with the bipolar resection loop24 and the button electrode has been reported to be as high as 2.4mm25. Meanwhile, the depth of penetration for holmium laser is reported at 0.44mm26. The probable reason we do not see an impact on erectile function is due to the fact that the majority of the operation is performed bluntly using the tip of the resection loop, and
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only focal pin point electrocautery is used to coagulate bleeding vessels. With more patient recruitment, we may see higher rates of erectile dysfunction similar to those reported with HoLEP. Complications Complications in the present series are comparable to other enucleation procedures. There were no perioperative clot retention or bleeding episodes requiring return to the operating room. There were no blood transfusions, which is consistent with the approximately 1% or less rate reported for BPEP, PkEP and HoLEP 7, 17, 19. Also, postoperative complications of BNC (4%) and urethral stricture (2%) appear to be expected given the published enucleation data 7, 8, 17, 19. A 6% UTI rate is slightly higher than those of other TuBE reports of 2-3%17, 19, but the overall numbers are small. Also, capsular perforation or undermining of the bladder neck occurred in 8% of patients in our study. We believe this rate reflects our learning curve and with experience will decrease. Initial experiences with HoLEP produced similar rates of capsular perforation27. Finally, our experience with post-operative stress and urge incontinence rates being the highest shortly after surgery and then, ultimately, decrease to around 2% are in line with both medium and long-term reports on various enucleation modalities7, 8, 17, 19. Limitations Beyond the retrospective, non-comparative nature of this review, there is no long-term follow up. In addition, a relative limitation is the size of the prostates in the present study. While larger glands can be enucleated using the bipolar technique, most of our prostates were less than 80 grams limiting direct comparison to the large prostate HoLEP data. Average 12 Page 12 of 21
prostate size is 50 grams in the present series and closer to 100 grams in a large HoLEP series by Krambeck et al7. The limitations of the procedure should also be addressed. In the presented study it appears TuBE procedures produce longer operative times. However, all but 3 outliers were
<150minutes and our operative time decreased by an average of 13 minutes between our first 20 procedures and the last 20 even though prostate size was equal reflecting our learning curve. Thus, while enucleation times are likely similar to those for HoLEP, resection versus morcellation times are likely not equal. No reports have compared morcellation versus postenucleation resection directly. Reported morcellation times are up to 5.5-7 g/min28. Therefore, to keep operative times appropriate, large glands, in the present study 168 grams and in prior reports 158 grams17, should likely not be attempted via TuBE without the use of morcellation devices. However, morcellation can still be performed after the tissue is completely enucleated via TuBE similar to a HoLEP. Advantages With these limitations in mind it is important to emphasize the advantages. First, as most urologists are well versed with resectoscopes given the large number of TURP and transurethral resection of bladder tumors performed during training, comfort with the approach is higher than that for laser enucleation devices. Having the ability to easily convert to traditional TURP during the process of learning the TuBE is a clear advantage over laser enucleation. One study evaluated the learning curve and identified PkEP required 30 operations until few conversions to conventional bipolar TURP occurred, and at 50 operations a 13 Page 13 of 21
stable surgical efficiency, as measured by ml/minute of tissue enucleated and resected, was noted29. In addition, anecdotal and personal experience has shown that laser enucleation is performed with the tip of the scope very near the tissue, limiting the global view of the capsular plane. Whereas, the added ability to manipulate the loop or button in and out of the working element of the resectoscope adds in the overall perspective, making the planes easier to visualize during enucleation. TuBE requires a bipolar energy source and resectoscope that are already widely used for other urologic procedures making them a vital part of any general urologic practice. Holmium lasers do have the added benefit of being utilized for stone treatment and will also be part of most urologists’ armamentarium. However, thulium and green light lasers have limited utility outside of BPH treatment. Another advantage of TuBE, even for large prostates up to approximately 170 grams, is the fact that no additional or specialized equipment is required. However, for glands larger than 170 grams options include: a staged approach, performing TuBE or laser enucleation with the aid of a morcellation device, or performing an open or robotic simple prostatectomy. Lastly, the present study indicates that TuBE can be used for small prostates with appropriate outcomes. This is a conclusion that has been established in the holmium laser enucleation literature for some time, though remains controversial 30. Conclusion. TuBE is an effective operation with similar outcomes to other enucleation procedures for prostate glands less than 170 grams. TuBE is effective in patients in retention, has no
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apparent effect on erectile function, and has comparable complication rates to other transurethral procedures.
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Pal Singh B, Dhakad U. Re: Holmium laser enucleation versus photoselective vaporization for prostatic adenoma greater than 60 ml: preliminary results of a prospective, randomized clinical trial: H. Elmansy, A. Baazeem, A. Kotb, H. Badawy, E. Riad, A. Emran and M. Elhilali J Urol, 2012;188:216-221. The Journal of urology. 2013;189:774-775.
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Zhang F, Shao Q, Herrmann TR, Tian Y, Zhang Y. Thulium laser versus holmium laser transurethral enucleation of the prostate: 18-month follow-up data of a single center. Urology. 2012;79:869-874.
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Tang K, Xu Z, Xia D, et al. Early outcomes of thulium laser versus transurethral resection of the prostate for managing benign prostatic hyperplasia: a systematic review and meta-analysis of comparative studies. Journal of endourology / Endourological Society. 2014;28:65-72.
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Neill MG, Gilling PJ, Kennett KM, et al. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006;68:1020-1024.
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Chen YB, Chen Q, Wang Z, et al. A prospective, randomized clinical trial comparing plasmakinetic resection of the prostate with holmium laser enucleation of the prostate based on a 2-year followup. The Journal of urology. 2013;189:217-222.
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Table 1. Preoperative factors Patient number
49
Mean Age
67 (54-88)
Mean follow up (months)
4.4 (1.2-10.7)
Patients in retention
28 (57%)
Prostate specific antigen (44 patients)
3.2 (0.1-15.8)
Prior surgical resection
9 patients (18%)
Prior prostate biopsy
10 patients (20%)
Mean PVR (mL)
278 (0-900)
Mean trans rectal ultrasound volume (grams)
50 (11-168)
Mean IPSS
22 (4-35)
Mean QOL score
5 (2-6)
Able to achieve erection
28 patients (57%)
Mean SHIM
7.4 (1-25)
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Table 2. Operative findings American Society of Anesthesiologists Score
2 (1-3)
Operative time
93 minutes (31-301)
Estimated blood loss
49 ml (5-300)
Mean pathology weight
18.0 grams (1.7-100.0)
Cancer diagnosis
3 (6%)
Resected Volume/Preoperative TRUS volume
0.30 (0.05-0.95)
Catheterization time
2 days (1-6)
Hospital stay
1 day (0-2)
Table 3. Complications Grade
Complication
Number
Total for Grade
Clavien I
Postoperative supraventricular tachycardia without intervention
1 (2%)
1
Clavien II
UTI
3 (6%)
7
Perforation or undermining of the bladder resulting in prolonged catheter
4 (8%)
Meatal stricture requiring urethroplasty
1 (2%)
Bladder neck contracture requiring incision
2 (4%)
Clavien III
3
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Table 4. Comparison of pre and postoperative factors. Preoperative
6 week
3 month (32 patients)
P value
IPSS score
22.2 (4-35)
9.0 (1-25)
8.0 (1-27)
<0.01
IPSS QOL
4.6 (2-6)
1.9 (2-6)
1.9 (2-6)
<0.01
SHIM
7.4 (1-25)
8.4 (1-25)
7.04 (1-25)
0.35
PVR
278 (0-900)
66 (0-300)
87 (0-432)
<0.01
PSA
3.2 (0.1-15.8)
Not tested
0.9 (0.06-4.65)
<0.01
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