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Initial experience of a single center with the use of ZSI 475 penile prosthesis |
Fulvio Colomboa,Giorgio Gentilea,*(),Valerio Vagnonia,Alessandro Fiorillob,Pietro Piazzab,Fabrizio Sartoriob,Alessandro Franceschellia
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a Andrology Unit, University Hospital S. Orsola-Malpighi, Bologna, Italy b Department of Urology, University of Bologna, Bologna, Italy |
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Abstract Objective To evaluate surgical outcomes after implantation of the Zephyr ZSI 475 inflatable penile prosthesis (IPP) and patients' quality of life. Methods From December 2014 to September 2018, 15 patients underwent prosthesis implantation with ZSI 475. A retrospective review of clinical data was performed. Patients' quality of life after implantation was investigated with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. Results The median age of patients was 57 years and the average follow-up time was 22 months. Twelve patients received a standard implantation due to severe erectile dysfunction (ED); three patients also presented penile curvature and additional corporoplasty with grafting was necessary. Three procedures had to be interrupted due to defects of the insertion tools. In one case a manufacturing defect resulted in a pump leak. In one case, a severe postoperative complication occurred, which requested explanation of the device. During the follow-up, four patients experienced mechanical failure of the prosthesis. Results of QoLSPP questionnaire at 12 months were skewed toward the positive end of the scale in all domains. Conclusion In our initial experience, ZSI 475 suffered a high rate of mechanical failures; on the other hand, the company showed great commitment in order to improve the quality and reliability of the device. The lower cost of ZSI 475 may add to the chances of the product to become a cost-effective alternative to treat those patient who need a IPP.
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Received: 13 July 2019
Available online: 10 February 2020
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Corresponding Authors:
Giorgio Gentile
E-mail: dr.giorgio.gentile@gmail.com
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Company | Model | Access | Length (cm) | Cylinders, tubing and coating | Pump and reservoir | AMS-Boston | AMS 700 LGX? preconnect AMS 700 CX preconnect AMS 700 LGX AMS 700 CX AMS 700 CXR preconnect | Infrapubic Penoscrotal | 12-15-18-21 (AMS 700 LGX) 12-15-18-21-24 (AMS 700 CX) 10-12-14-18 (AMS 700 CXR Preconnect) | - Three-ply design of the cylinders consisting of an inner silicone layer that abutted a silicone-coated unidirectional woven Dacro-Lycra fabric layer - With-without InhibiZone? coating (antibiotic impregnation rifampicin and minocycline hydrochloride) - Kink-resistant tubing | - Momentary Squeeze pump (smaller than previous pump and easier deflation due to the quick squeeze button) - Lockout valve (within the pump) in order to reduce the risk of auto-inflation - Conceal Reservoir (flat reservoir) | Coloplast | Titan touch Titan touch narrow base | Infrapubic Penoscrotal | 14-16-18-20-22 (Titan touch) 11-14-16-18 (Titan touch narrow base) 24-26-28 (XL sizes) | - Bioflex? (polyurethane material) allows very good tensile strenght without compromising biocompatibility of the cylinders - Soft-molded cylinder tips - Hydrophilic coating - Zero-degree tubing | - Touch pump (single touch button that allows natural deflection of the device) - Cloverleaf reservoir (low risk of self-inflation with the block valve ?) | Zephyr Surgical Implant | ZSI 475 | Penoscrotal | 12-15-18-21 22-25 (XL sizes) | - Cylinders: three layers (silicone-tissue-silicone) reducing the risk of accidental piercing during the procedure; narrow and flexible proximal portion - Hydrophilic PVP coating - Armed tubings with a redoubt portion running inside the corpus cavernosum | - Pump with open/close valve (reduced risk for mechanical failure), longer exit tube to decrease the risk of breakage and softer valve axle with button to ease deflation - Reinforced valve within the pump (low risk of incidental auto-inflation) - Reservoir preconnected to pump |
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Comparative table: Main characteristics of AMS-Boston, Coloplast and Zephyr surgical implants devices.
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ZSI 475 standard size kit.
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ZSI 475 aspect with flexible rear tips.
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ZSI 475 Kaplan-Meier overall survival estimate (%).
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Domains | Item | Valid responses (n) | Mean | Median | Functional | Prosthesis adequacy | 15 | 4.38 | 5 | Ease/simplicity of use | 15 | 4.50 | 5 | Duration of implant | 15 | 4.53 | 5 | Penile rigidity | 15 | 4.00 | 4 | Fulfillment of expectations | 15 | 3.92 | 4 | Personal | Sexual desire | 15 | 4.23 | 4 | Liveliness and wit | 15 | 3.76 | 4 | Security | 15 | 3.92 | 4 | Sexual experience | 15 | 4.15 | 4 | Relational | Well-being of the couple | 15 | 3.76 | 4 | Frequency of orgasms | 15 | 4.30 | 4 | Frequency of sexual intercourse | 15 | 3.30 | 3 | Partner satisfaction | 15 | 3.53 | 4 | Social | Daily life | 15 | 4.07 | 4 | General well-being | 15 | 3.84 | 4 | Feeling like others | 15 | 3.84 | 4 |
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QoLSPP questionnaire item scores.
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