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Article of the week: Aquablation for benign prostatic hyperplasia in large prostates: 6‐month results from the WATER II trial

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

We invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL): 6‐month results from the WATER II trial

Mihir Desai*, Mo Bidair, Kevin C. Zorn, Andrew Trainer§, Andrew Arther§, Eugene Kramolowsky, Leo Doumanian*, Dean Elterman**, Ronald P. Kaufman Jr.††, James Lingeman‡‡, Amy Krambeck‡‡, Gregg Eure§§, Gopal Badlani¶¶, Mark Plante***, Edward Uchio†††, Greg Gin†††, Larry Goldenberg‡‡‡, Ryan Paterson‡‡‡, Alan So‡‡‡, Mitch Humphreys§§§, Claus Roehrborn¶¶¶, Steven Kaplan****, Jay Motola**** and Naeem Bhojani

*Institute of Urology, University of Southern California, Los Angeles, San Diego Clinical Trials, San Diego, CA, USA, University of Montreal Hospital Center, Université de Montréal, Montréal, QC, Canada, §Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, Virginia Urology, Richmond, VA, USA, **University of Toronto – University HealthNetwork, Toronto, ON, Canada, ††Albany Medical College, Albany, NY, ‡‡Indiana University Health Physicians, Indianapolis, IN, §§Urology of Virginia, Virginia Beach, VA, ¶¶Wake Forest School of Medicine, Winston-Salem, NC, ***University of Vermont Medical Center, Burlington, VT, †††VA Long Beach Healthcare System, Long Beach, CA, USA, ‡‡‡University of British Columbia, Vancouver, BC, Canada, §§§Mayo Clinic Arizona, Scottsdale, AZ, ¶¶¶UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX, and ****Icahn School of Medicine at Mount Sinai, New York, NY, USA

 

Abstract

Objective

To present 6‐month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL.

Methods

Between September and December 2017, 101 men with LUTS attributable to BPH were prospectively enrolled at 16 centers in Canada and the USA.

Results

The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study’s primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post‐void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate‐specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction.

Conclusions

Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.

Article of the week: Use of indocyanine green to minimise uretero‐enteric strictures after robotic radical cystectomy

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial and a visual abstract written by members of the urological community, and a video produced by the authors. These are intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Use of indocyanine green to minimise uretero‐enteric strictures after robotic radical cystectomy

Nariman Ahmadi, Akbar N. Ashrafi, Natalie Hartman, Aliasger Shakir, Giovanni E. Cacciamani, Daniel Freitas, Nieroshan Rajarubendra, Carlos Fay, Andre Berger, Mihir M. Desai, Inderbir S. Gill and Monish Aron

 

USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

 

Abstract

Objective

To evaluate the impact of indocyanine green (ICG) for assessing ureteric vascularity on the rate of uretero‐enteric stricture formation after robot‐assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD).

Patients and methods

We identified 179 patients undergoing RARC and ICUD between January 2014 and May 2017, and divided the patients into two groups based on the utilisation of ICG for the assessment of ureteric vascularity (non‐ICG group and ICG group). We retrospectively reviewed the medical records to identify the length of ureter excised. Demographic, perioperative outcomes (including 90‐day complications and readmissions), and the rate of uretero‐enteric stricture were compared between the two groups. The two groups were compared using the t‐test for continuous variables and the chi‐squared test for categorical variables. A P < 0.05 was considered statistically significant.

Results

A total of 132 and 47 patients were in the non‐ICG group and the ICG group, respectively. There were no differences in baseline characteristics and perioperative outcomes including operating time, estimated blood loss, and length of stay. The ICG group was associated with a greater length of ureter being excised during the uretero‐enteric anastomosis and a greater proportion of patients having long segment (>5 cm) ureteric resection. The median follow‐up was 14 and 12 months in the non‐ICG and ICG groups, respectively. The ICG group was associated with no uretero‐enteric strictures compared to a per‐patient stricture rate of 10.6% and a per‐ureter stricture rate of 6.6% in the non‐ICG group (P = 0.020 and P = 0.013, respectively).

Conclusion

The use of ICG fluorescence to assess distal ureteric vascularity during RARC and ICUD may reduce the risk of ischaemic uretero‐enteric strictures. The technique is simple, safe, and reproducible. Larger studies with longer follow‐up are needed to confirm our findings.

Editorial: Reducing the rate of uretero‐enteric strictures after robot‐assisted cystectomy: a green light for immunofluorescence?

In the current edition of the BJUI, Ahmadi et al. [1] from the University of Southern California describe their experience with the use of indocyanine green (ICG) during robot‐assisted radical cystectomy (RC); specifically, they discuss its potential utility in assessing the vascularity of distal ureteric segments ahead of anastomosis to the bowel segment during urinary diversion.

Benign postoperative ureteric strictures are thought to be largely attributable to inadequate vascularization of the distal ureter on account of its segmental blood supply. Despite meticulous dissection technique and avoidance of traction or anastamotic tension, many series still report a stricture rate in the order of 10% in both open and minimally invasive surgery. Conventionally, the left ureter is associated with a higher risk because of its more extensive mobilization and longer trajectory behind the recto‐sigmoid.

Notably, there were early indications in the 1990s that minimally invasive surgery had the potential to increase the risk of ureteric complications, and this was highlighted by various authors pioneering the introduction of laparoscopic live donor nephrectomy [2,3,4]. Surgeons at that time cited magnification as a potential culprit, with intra‐operative views suggesting a well‐preserved peri‐ureteric tissue bundle but an ex vivo ureter that appeared more denuded when examined with the ‘naked eye’.

In the present study, the theoretical construct applied was that the use of ICG could potentially remove the subjectivity of the surgeon’s assessment of distal ureteric vascularity and replace it with a more objective visual guide through the use of immunofluorescence after administration of ICG. The study design was an interrupted time series rather than a randomized trial, but was set in the context of a unit where all surgeons reported over a decade of experience each in performing robot‐assisted RC in a high‐volume setting.

Indocyanine green is a fluorescent, non‐toxic tracer that can be visualized with an infra‐red camera but remains non‐visible in conventional white light. It established its initial position within the robotic theatre by being popularized for the assessment of vascularity of renal tumours, particularly during nephron‐sparing surgery [5]. Once injected, there is an initial arterial phase followed by a later tissue perfusion phase where the tissue itself can be seen to fluoresce if vascularized adequately. The initial arterial phase is rapid (30 s), followed several minutes later by the perfusion phase.

After its introduction at the USC Institute of Urology, surgeons used the infra‐red findings of ICG administration to guide the length of distal ureteric resection in preparation for the uretero‐enteric anastomosis. Ureteric stricture rates were assessed at 12–14 months postoperatively based on clinical or radiological suspicion of stricturing. Confirmatory tests included a loopogram or cystogram and functional nuclear imaging. In some cases, nephrostomy and antegrade studies were performed.

The study found a marked reduction in stricture rate, from 10.6% in the non‐ICG group to an undetectable rate in the ICG group at this stage of follow‐up. This was associated with a greater length of resected ureteric segment in the ICG group compared to the non‐ICG group.

If viewed in the context of a single‐centre feasibility study, then the findings suggest a technique that is safe, is reproducible and has the potential to markedly reduce a challenging and not insignificant postoperative complication of RC. The findings would also support the authors’ theoretical construct that ischaemia and fibrosis are the key drivers of ureteric stricturing following RC.

It is of course acknowledged in the paper that further studies across multiple centres are needed for validation, but the findings so far would indicate that extending its further evaluation is warranted. It will also be of interest to see whether surgeons experienced in this technique would eventually develop the expertise to identify a poorly perfused ureter without the need for ICG based on pattern recognition and or greater confidence in excising longer ureteric segments.

References

  1. Ahmadi NAshrafi ANHartman N et al. Use of indocyanine green to minimise uretero‐enteric strictures after robotic radical cystectomy. BJU Int 2019124302– 7
  2. Ratner LECisek LJMoore RGCigarroa FGKaufman HSKavoussi LRLaparoscopic live donor nephrectomy. Transplantation 1995601047– 9
  3. Philosophe BKuo PCSchweitzer EJ et al. Laparoscopic vs open donor nephrectomy: comparing ureteral complications in the recipients and improving the laparoscopic technique. Transplantation 199968497– 502
  4. Kavoussi LRLaparoscopic donor nephrectomy. Kidney Int 2000572175– 86
  5. Tobis SKnopf JKSilvers CR et al. Near infrared fluorescence imaging after intravenous indocyanine green: initial clinical experience with open partial nephrectomy for renal cortical tumors. Urology 201279958– 64

 

Video: Use of indocyanine green to minimise uretero-enteric strictures following RARC

Use of indocyanine green to minimise uretero‐enteric strictures after robotic radical cystectomy

Abstract

Objective

To evaluate the impact of indocyanine green (ICG) for assessing ureteric vascularity on the rate of uretero‐enteric stricture formation after robot‐assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD).

Patients and methods

We identified 179 patients undergoing RARC and ICUD between January 2014 and May 2017, and divided the patients into two groups based on the utilisation of ICG for the assessment of ureteric vascularity (non‐ICG group and ICG group). We retrospectively reviewed the medical records to identify the length of ureter excised. Demographic, perioperative outcomes (including 90‐day complications and readmissions), and the rate of uretero‐enteric stricture were compared between the two groups. The two groups were compared using the t‐test for continuous variables and the chi‐squared test for categorical variables. A P < 0.05 was considered statistically significant.

Results

A total of 132 and 47 patients were in the non‐ICG group and the ICG group, respectively. There were no differences in baseline characteristics and perioperative outcomes including operating time, estimated blood loss, and length of stay. The ICG group was associated with a greater length of ureter being excised during the uretero‐enteric anastomosis and a greater proportion of patients having long segment (>5 cm) ureteric resection. The median follow‐up was 14 and 12 months in the non‐ICG and ICG groups, respectively. The ICG group was associated with no uretero‐enteric strictures compared to a per‐patient stricture rate of 10.6% and a per‐ureter stricture rate of 6.6% in the non‐ICG group (P = 0.020 and P = 0.013, respectively).

Conclusion

The use of ICG fluorescence to assess distal ureteric vascularity during RARC and ICUD may reduce the risk of ischaemic uretero‐enteric strictures. The technique is simple, safe, and reproducible. Larger studies with longer follow‐up are needed to confirm our findings.

 

Article of the week: Selective tetramodal bladder‐preservation therapy, incorporating induction chemoradiotherapy and consolidative partial cystectomy with pelvic lymph node dissection for MIBC

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urological community, a visual abstract by one of our resident artists and a video produced by the authors. These are intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Selective tetramodal bladder‐preservation therapy, incorporating induction chemoradiotherapy and consolidative partial cystectomy with pelvic lymph node dissection for muscle‐invasive bladder cancer: oncological and functional outcomes of 107 patients

 

Toshiki Kijima*, Hajime Tanaka*, Fumitaka Koga, Hitoshi Masuda, Soichiro Yoshida*, Minato Yokoyama*, Junichiro Ishioka*, Yoh Matsuoka*, Kazutaka Saito*, Kazunori Kihara* and Yasuhisa Fujii*

 

*Department of Urology, Tokyo Medical and Dental University, Department of Urology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, andDepartment of Urology, National Cancer Center Hospital East, Chiba, Japan

 

Abstract

Objectives

To evaluate the oncological and functional outcomes associated with selective tetramodal bladder‐sparing therapy, comprising maximal transurethral resection of bladder tumour (TURBT), induction chemoradiotherapy (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection (PLND).

Materials and Methods

In the present study, 154 patients with non‐metastatic muscle‐invasive bladder cancer (MIBC), prospectively enrolled in the tetramodal bladder‐preservation protocol, were analysed. After TURBT and induction CRT, patients showing complete remission were offered consolidative PC with PLND for the achievement of bladder preservation. Pathological response to induction CRT was evaluated using PC specimens. Oncological and functional outcomes after bladder preservation were evaluated using the following endpoints: MIBC‐recurrence‐free survival (RFS); cancer‐specific survival (CSS); overall survival (OS), and cross‐sectional assessments of preserved bladder function and quality of life (QoL) including uroflowmetry, bladder diary, International Prostate Symptom Score, Overactive Bladder Symptom Score and the 36‐item Short‐Form Health Survey (SF‐36) score.

Results

The median follow‐up period was 48 months. Complete MIBC remission was achieved in 121 patients (79%) after CRT, and 107 patients (69%) completed the tetramodal bladder‐preservation protocol comprising consolidative PC with PLND. Pathological examination in these 107 patients revealed residual invasive cancer (≥pT1) that was surgically removed in 11 patients (10%) and lymph node metastases in two patients (2%). The 5‐year MIBC‐RFS, CSS and OS rates in the 107 patients who completed the protocol were 97%, 93% and 91%, respectively. As for preserved bladder function, the median maximum voided volume, post‐void residual urine volume, and nighttime frequency were 350 mL, 25 mL, and two voids, respectively. In the SF‐36, patients had favourable scores, equivalent to the age‐matched references in all the QoL scales.

Conclusion

Selective tetramodal bladder‐preservation therapy, incorporating consolidative PC with PLND, yielded favourable oncological and functional outcomes in patients with MIBC. Consolidative PC may have contributed to the low rate of MIBC recurrence in patients treated according to this protocol.

Editorial: A new horizon for bladder preservation in muscle‐invasive bladder cancer

We are witnessing a shift toward treatment de‐escalation in muscle‐invasive bladder cancer. Patients diagnosed with muscle‐invasive bladder cancer have traditionally faced two treatment options: (1) radical cystectomy with urinary diversion or (2) chemoradiation, both of which can impact quality of life and subsequent morbidity while variably influencing recurrence rates. Recent research has turned toward treatment de‐escalation in an attempt to preserve the bladder while maintaining survival rates. In this issue of BJUI, Kijima et al. [1] propose a tetramodal treatment regimen which combines chemoradiation with partial cystectomy, in an attempt to avoid radical cystectomy without compromising recurrence and survival. Similar ongoing clinical trials are beginning to explore the role of treatment de‐escalation by potentially avoiding cystectomy and/or radiation altogether. Dr Daniel Geynisman is leading a phase II trial at Fox Chase Medical Centre to investigate the role of single‐modality chemotherapy [2]. In that study, therapy is individualized by applying a risk‐adapted approach to identify genetic mutations in cancer cells to predict whether chemotherapy will be effective in eliminating all cancer and preventing future recurrence and metastasis. A related study led by Dr Alexander Kutikov is assessing the reliability of cystoscopic evaluation in predicting pT0 urothelial carcinoma of the bladder at the time of radical cystectomy [3]. By identifying urine biomarkers, investigators could potentially identify those patients who will respond completely to neoadjuvant chemotherapy, thus obviating the need for subsequent cystectomy.

While these studies have not yet provided definitive evidence to forgo definitive therapy (whether it be chemoradiotherapy or radical cystectomy), in this issue of BJUI, Kijima et al. [1] propose similar de‐escalation efforts to promote bladder preservation in a carefully selected population, by preserving quality of life with chemoradiation while addressing the potential increased risk of recurrence with partial cystectomy. The authors report the oncological and functional outcomes of a series of patients who underwent a new tetramodal bladder preservation treatment combination for muscle‐invasive bladder cancer [1]. After patients underwent maximal transurethral bladder tumour resection, induction chemoradiotherapy and consolidative partial cystectomy with pelvic lymph node dissection, only 4% of patients experienced recurrence of muscle‐invasive bladder cancer over a median follow‐up of 2 years, with an overall cancer recurrence rate of 18% and a 5‐year cancer‐specific survival of 93%.

When comparing these findings with the bladder cancer recurrence rates after partial cystectomy in the setting of muscle‐invasive disease (~40%) [4] and trimodal bladder preservation therapy (11–19%) [5], the findings presented in this paper are remarkable. Although the lower recurrence rate observed in this patient series may be influenced by a shorter follow‐up time than other studies looking at similar outcomes in patients treated for muscle‐invasive bladder cancer, the results of this paper demonstrate a promising frontier in bladder cancer treatment, combining the benefits of trimodal therapy with the extirpative intent of surgery while preserving the bladder. The long‐term (>5 year) cancer‐specific outcomes of these patients, however, remain unknown and are important to examine in order to contribute to our understanding of the true efficacy of this bladder cancer management strategy.

Given that treatment de‐escalation and bladder preservation share the goal of reduced morbidity and improved quality of life, functional outcomes after tetramodal therapy remain unclear yet critical. Differences in functional outcomes between cystectomy and bladder preservation also remain unclear, as randomized trials in this space are challenging to accrue, a lesson learned with the SPARE trial [67]. Certainly, radiation and partial cystectomy are interventions that can decrease bladder capacity and result in irritative LUTS. The extent to which tetramodal therapy impacts these functional outcomes will be important to address moving forward. Despite the absence of a pre‐treatment baseline symptom profile, the overall favourable urinary quality‐of‐life score and reasonable bladder capacity after treatment completion are encouraging and suggest adequate patient tolerability.

As we usher in a new era of personalized medicine in muscle‐invasive bladder cancer, tetramodal bladder preservation treatment may have a role in bladder preservation by decreasing recurrence while maintaining quality of life. We look forward to long‐term data regarding oncological and functional outcomes to determine if this treatment strategy offers a significant benefit when compared with the ‘gold standard’ therapies for muscle‐invasive bladder cancer.

by Pauline Filippou and Angela B Smith

References

  1. Kijima TTanaka HKoga F et al. Selective tetramodal bladder‐preservation therapy, incorporating induction chemoradiotherapy and consolidative partial cystectomy with pelvic lymph node dissection for muscle‐invasive bladder cancer: oncological and functional outcomes of 107 patients. BJU Int 2019124242– 50
  2. Phase II Trial of Risk Enabled Therapy after Initiating Neoajduvant Chemotherapy for Bladder Cancer (RETAIN BLADDER)2018. Available at: https://www.carislifesciences.com/wp-content/uploads/2018/02/ASCO-GU-A-Phase-II-Trial-of-Risk-Enabled-Therapy-After-Initiating-Neoadjuvant-Chemotherapy-for-Bladder-Cancer-RETAIN-BLADDER.pdf. Accessed April 2019
  3. Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02968732. Accessed April 2019
  4. Fahmy NAprikian ATanguay S et al. Practice patterns and recurrence after partial cystectomy for bladder cancer. World J Urol 201028419– 23
  5. Ploussard GDaneshmand SEfstathiou JA et al. Critical analysis of bladder sparing with trimodal therapy in muscle‐invasive bladder cancer: a systematic review. Eur Urol 201466120– 37
  6. Huddart RABirtle AMaynard L et al. Clinical and patient‐reported outcomes of SPARE ‐ a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int2017120639– 50
  7. Huddart RAHall ELewis RBirtle AGroup STMLife and death of spare (selective bladder preservation against radical excision): reflections on why the spare trial closed. BJU Int 2010106:753– 5

 

Video: Selective tetramodal bladder‐preservation therapy for MIBC

Selective tetramodal bladder‐preservation therapy, incorporating induction chemoradiotherapy and consolidative partial cystectomy with pelvic lymph node dissection for muscle‐invasive bladder cancer: oncological and functional outcomes of 107 patients

Abstract

Objectives

To evaluate the oncological and functional outcomes associated with selective tetramodal bladder‐sparing therapy, comprising maximal transurethral resection of bladder tumour (TURBT), induction chemoradiotherapy (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection (PLND).

Materials and Methods

In the present study, 154 patients with non‐metastatic muscle‐invasive bladder cancer (MIBC), prospectively enrolled in the tetramodal bladder‐preservation protocol, were analysed. After TURBT and induction CRT, patients showing complete remission were offered consolidative PC with PLND for the achievement of bladder preservation. Pathological response to induction CRT was evaluated using PC specimens. Oncological and functional outcomes after bladder preservation were evaluated using the following endpoints: MIBC‐recurrence‐free survival (RFS); cancer‐specific survival (CSS); overall survival (OS), and cross‐sectional assessments of preserved bladder function and quality of life (QoL) including uroflowmetry, bladder diary, International Prostate Symptom Score, Overactive Bladder Symptom Score and the 36‐item Short‐Form Health Survey (SF‐36) score.

Results

The median follow‐up period was 48 months. Complete MIBC remission was achieved in 121 patients (79%) after CRT, and 107 patients (69%) completed the tetramodal bladder‐preservation protocol comprising consolidative PC with PLND. Pathological examination in these 107 patients revealed residual invasive cancer (≥pT1) that was surgically removed in 11 patients (10%) and lymph node metastases in two patients (2%). The 5‐year MIBC‐RFS, CSS and OS rates in the 107 patients who completed the protocol were 97%, 93% and 91%, respectively. As for preserved bladder function, the median maximum voided volume, post‐void residual urine volume, and nighttime frequency were 350 mL, 25 mL, and two voids, respectively. In the SF‐36, patients had favourable scores, equivalent to the age‐matched references in all the QoL scales.

Conclusion

Selective tetramodal bladder‐preservation therapy, incorporating consolidative PC with PLND, yielded favourable oncological and functional outcomes in patients with MIBC. Consolidative PC may have contributed to the low rate of MIBC recurrence in patients treated according to this protocol.

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