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First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris™): a European prospective multicenter study

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Abstract

Purpose

We evaluated a new single-use digital flexible cystoscope with an integrated grasper designed for double-J stent removal, Isiris™, addressing success rate, image quality, deflection, maneuverability and grasper functionality.

Methods

In September 2015, a prospective cohort study was conducted in six tertiary European reference centers. All consecutive patients included underwent double-J stent removal and were 18 years or older. Success rate was defined by complete stent removal. Image quality, deflection, maneuverability and grasper functionality were rated with a Likert scale.

Results

A total of 83 procedures were performed. 82% of procedures were performed in the endoscopy room, while the others were in the operating room since a consecutive endourological intervention was planned. The median duration of stent implantation was 28 days [14; 60]. In five patients, stent removal was not possible. Four patients had an incrusted double-J stent, and in one patient, the stent migrated into the ureter. After unsuccessful attempts of stent removal with conventional flexible cystoscope and grasper, the five patients had to be scheduled for an ureterorenoscopy procedure to remove the stent. In the other 78 patients, all double-J stents were removed successfully. Image quality, deflection, maneuverability and grasper functionality were rated as “very good” in 72.3, 78.3, 72.3 and 73.5%, respectively.

Conclusion

This multicenter clinical evaluation of Isiris™ displayed good image quality, active deflection, maneuverability and grasper functionality. Further evaluation of stent removal outcomes, cost analysis and microbiology will help to delineate the possible place of Isiris™ in the current practice.

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Acknowledgements

The authors would like to thank Porgès-Coloplast for providing Isiris™ endoscopes in each center in order to evaluate its performance.

Authors’ contribution

SD, GK: Protocol/project development, Data collection or management, Data analysis, Manuscript writing/editing; GG, JLP, JMP, SP, MS, JdlR, OT: Protocol/project development, Data collection or management, Manuscript writing/editing.

Funding

The Isiris™ scopes were made available by Porgès-Coloplast.

Author information

Author notes

    Authors and Affiliations

    1. Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France

      Steeve Doizi & Olivier Traxer

    2. Pierre et Marie Curie University, Paris, France

      Steeve Doizi & Olivier Traxer

    3. Sorbonne Universités, UPMC Univ Paris 06, AP-HP, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, 4 rue de la Chine, 75020, Paris, France

      Steeve Doizi & Olivier Traxer

    4. Department of Urology, Academic Medical Center, Amsterdam, The Netherlands

      Guido Kamphuis & Jean de la Rosette

    5. Department of Urology, IRCCS San Raffaele Scientific Institute, Ville Turro Division, Milan, Italy

      Guido Giusti & Silvia Proietti

    6. Department of Urology, Hospital Universitario La Ribera, Alzira, Valencia, Spain

      J. L. Palmero

    7. Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK

      J. M. Patterson

    8. Department of Urology, Technische Universität München, Munich, Germany

      Michael Straub

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    1. Steeve Doizi
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    Correspondence to Olivier Traxer.

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    Conflict of interest

    Steeve Doizi, Guido Kamphuis, Silvia Proietti: None; Guido Giusti: Boston Scientific, Coloplast, Cook Medical, Olympus, Karl Storz, Rocamed; Jose Luis Palmero: Boston Scientific, Coloplast, Cook Medical; Jake Patterson: Boston Scientific, Coloplast; Michael Straub: Richard Wolf Endoskope, Sanochemia Pharmazeutika AG; Jean de la Rosette: Boston Scientific, Coloplast, Olympus, Karl Storz; Olivier Traxer: Boston Scientific, Coloplast, Lumenis, Olympus, Rocamed.

    Ethical approval

    All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

    Informed consent

    Informed consent was obtained from all individual participants included in the study.

    Additional information

    Steeve Doizi and Guido Kamphuis have equally contributed to this work.

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    Doizi, S., Kamphuis, G., Giusti, G. et al. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris™): a European prospective multicenter study. World J Urol 35, 1269–1275 (2017). https://doi.org/10.1007/s00345-016-1986-0

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    • DOI: https://doi.org/10.1007/s00345-016-1986-0

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