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Article of the Week: Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II study

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 accompanying editorial written by a prominent member of the urological community. This blog is 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 month, it should be this one.

Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II study

Francesco Porpiglia* , Riccardo Bertolo*, Cristian Fiori*, Matteo Manfredi*, Sabrina De Cillis* and Stefano Geuna

 

*Division of Urology, Department of Oncology, and Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Turin, Italy

 

Abstract

Objective

To evaluate the feasibility and the safety of applying chitosan membrane (ChiMe) on the neurovascular bundles (NVBs) after nerve‐sparing robot‐assisted radical prostatectomy (NS‐RARP). The secondary aim of the study was to report preliminary data and in particular potency recovery data.

Patients and Methods

This was a single‐centre, single‐arm prospective study, enrolling all patients with localised prostate cancer scheduled for RARP with five‐item version of the International Index of Erectile Function scores of >17, from July 2015 to September 2016. All patients underwent NS‐RARP with ChiMe applied on the NVBs. The demographics, perioperative, postoperative and complications data were evaluated. Potency recovery data were evaluated in particular and any sign/symptom of local allergy/intolerance to the ChiMe was recorded and evaluated.

Results

In all, 140 patients underwent NS‐RARP with ChiMe applied on the NVBs. Applying the ChiMe was easy in almost all the cases, and did not compromise the safety of the procedure. None of the patients reported signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging.

Conclusion

In our experience, ChiMe applied on the NVBs after NS‐RARP was feasible and safe, without compromising the duration, difficulty or complication rate of the ‘standard’ procedure. No patients had signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging. A comparative cohort would have added value to the study. The present paper was performed before Conformité Européene (CE)‐mark achievement.

Editorial: Nerve wrapping with biomaterials during radical prostatectomy to improve potency recovery

Radical prostatectomy is one of the standard treatment options for localized prostate cancer. The functional outcomes of radical prostatectomy are steadily improving along with better understanding of the surgical anatomy involved. Technological and technical advancements have helped improve continence outcomes significantly. High‐volume centres have consistently reported continence rates of >95% 1; however, potency recovery is the major limiting factor in achieving trifecta, even with full nerve‐sparing. Neuropraxia secondary to surgical dissection is one of the factors delaying potency recovery. We were the first to introduce the concept of protecting the neurovascular bundle using a wrap. In 2015, we first published our work on dehydrated human amnion‐chorion membrane (dHACM) nerve wrapping, a potential means of improving functional outcomes after radical prostatectomy 2.

Clinical applications of biomaterials are increasingly being explored. Their biological and physiochemical properties influence their role in peripheral nervous system regenerative therapy 3. Amniotic membrane graft has multiple growth factors including epidermal growth factor, vascular endothelial growth factor and anti‐inflammatory chemokines and cytokines including interleukin (IL)‐1, IL‐10 and IL‐1ra. In vitro and in vivo studies have reported that dHACM minimizes the surgical trauma‐induced inflammation and peri‐neural adhesions. These membranes are commercially available in various sizes for clinical use.

Porpiglia et al. 4 have reported their work on chitosan membrane application on the prostatic neurovascular bundle. Their phase II study is a step towards finding an ideal biomaterial favouring peripheral nerve healing. Chitosan is another potential biomaterial made of glucosamine and N‐acetyl glucosamine polymer which are natural components of mammalian tissues 5. Chitosan is hypoallergenic and only transiently stimulates the immune system and ultimately becomes bio‐tolerated and metabolized. It is not possible to develop specific antibodies against it because there are no proteins and lipids in its structure. Chitosan has inherent antimicrobial activity as its positive loads destabilize the membrane integrity of microorganisms. The inherent haemostatic and antimicrobial action of chitosan favour its application in wound healing. Chitosan has been extensively researched as a carrier molecule for biologically active particles and a scaffold in tissue engineering. Porpiglia et al. 4 have reported the safety and feasibility of its application for neurovascular bundle wrap during radical prostatectomy. In their non‐comparative study, they observed 96.4% continence and 68.6% potency recovery within 6 months. Comparative clinical trials are recommended to study its advantages in both partial and full nerve‐sparing settings. Membranes were manufactured from chitosan solution and sterilized for the purposes of the study. Pending approval by the regulators, study in other centres using chitosan membrane may be challenging.

The urological community has long been searching for ways to optimize functional outcomes after radical prostatectomy. Even for an ideal candidate with full nerve‐sparing, potency recovery is not assured. Several technical and technological modifications are being explored to address this concern. Bio-materials hold potential, and further exploration is warranted in the form of multicentre and randomized trials.

Hariharan Palayapalayam GanapathiFikret OnolTravis Rogers and Vipul Patel
Global Robotics Institute at Florida Hospital, University of Central Florida College of Medicine, Celebration, FL, USA

 

References

 

  • Patel VR, Abdul‐Muhsin HM, Schatloff O et al.Critical review of ‘pentafecta’ outcomes after robot‐assisted laparoscopic prostatectomy in high‐volume centresBJU Int2011108: 1007–17

 

  • Patel VR, Samavedi S, Bates AS et al.Dehydrated Human Amnion/Chorion membrane allograft nerve wrap around the prostatic neurovascular bundle accelerates early return to continence and potency following robot‐assisted radical prostatectomy: propensity score‐matched analysisEur Urol201567: 977–80

 

  • Dalamagkas K, Tsintou M, Seifalian A. Advances in peripheral nervous system regenerative therapeutic strategies: a biomaterials approachMater Sci Eng C Mater Biol Appl201665: 425–32

 

  • Porpiglia F, Bertolo R, Fiori C, Manfredi M, De Cillis S, Geuna S. Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II studyBJU Int2018121: 473–9

 

  • Rodríguez‐Vázquez M, Vega‐Ruiz B, Ramos‐Zúñiga R, Saldaña‐Koppel DA, Quiñones‐Olvera LF. Chitosan and its potential use as a scaffold for tissue engineering in regenerative medicineBiomed Res Int20152015: 821279

 

Video: Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II study

Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II study

 

Abstract

Objective

To evaluate the feasibility and the safety of applying chitosan membrane (ChiMe) on the neurovascular bundles (NVBs) after nerve‐sparing robot‐assisted radical prostatectomy (NS‐RARP). The secondary aim of the study was to report preliminary data and in particular potency recovery data.

Patients and Methods

This was a single‐centre, single‐arm prospective study, enrolling all patients with localised prostate cancer scheduled for RARP with five‐item version of the International Index of Erectile Function scores of >17, from July 2015 to September 2016. All patients underwent NS‐RARP with ChiMe applied on the NVBs. The demographics, perioperative, postoperative and complications data were evaluated. Potency recovery data were evaluated in particular and any sign/symptom of local allergy/intolerance to the ChiMe was recorded and evaluated.

Results

In all, 140 patients underwent NS‐RARP with ChiMe applied on the NVBs. Applying the ChiMe was easy in almost all the cases, and did not compromise the safety of the procedure. None of the patients reported signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging.

Conclusion

In our experience, ChiMe applied on the NVBs after NS‐RARP was feasible and safe, without compromising the duration, difficulty or complication rate of the ‘standard’ procedure. No patients had signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging. A comparative cohort would have added value to the study. The present paper was performed before Conformité Européene (CE)‐mark achievement.

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