Prospective Evaluation of Patient Satisfaction, and Surgeon and Patient Trainer Assessment of the Coloplast Titan One Touch Release Three-Piece Inflatable Penile Prosthesis
ABSTRACT Introduction. A single-armed, prospective, multicenter international study evaluated the redesigned Coloplast Titan One Touch Release (OTR) pump inflatable penile prosthesis. The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of opposing touch pads. Aims. To assess the impact of a new penile prosthesis design, the Titan OTR, on patient ease of operation. Furthermore, to assess patient satisfaction, surgeon acceptance, and the ease with which patients were trained in device operation in the clinic setting. Methods. A total of 113 eligible patients from eight centers were recruited from men presenting with erectile dysfunction without prior prosthetic implantation. The subjects had a mean age of 61 years, and had a number of comorbidities, including diabetes (31.9%), hypertension (34.5%), and Peyronie's disease (23.9%). All underwent implantation of the study device. Main Outcome Measures. Questionnaires were used to capture patient satisfaction as well as physician feedback on ease of implantation and patient education. A paired analysis was completed for patient satisfaction at 6 (N = 96) and 12 (N = 90) months. Results. Overall satisfaction with the device was 90.6% and 90.0% at 6 and 12 months, respectively. The primary end point, ease of deflation, was seen in 70.8% and 73.3% at these two time points, with the 12-month value statistically better than historical controls. Physicians overwhelmingly reported straightforward/simple intraoperative product preparation (97.3%) and equivalent or easier training compared with their previous pump of choice (96.4%). Adverse events for all subjects (N = 113) included removal of the device in four cases (3.5%) for infection and one case for chronic pain (0.8%). Conclusions. The Titan OTR represents an advance in penile prosthetic technology that is well accepted by patients and physicians. The study design allowed for realistic evaluation of the new technology aimed at enhancing clinical outcomes. Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, and Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast Titan One Touch Release three-piece inflatable penile prosthesis. J Sex Med 2012;9:2467-2474.
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ABSTRACT: Introduction We reviewed retrospectively the use of penile prostheses, including the indications and complications of penile prosthesis surgery. Methods We identified publications and the reported advances in penile prosthesis surgery between 1987 and 2012 in Pub-Med, and published information from American Medical Systems, Inc. (Minnetonka, MN, USA) and Coloplast Corporation (Humlebaek, Denmark), using the keywords ‘penile prosthesis’, ‘erectile dysfunction’, ‘mechanical reliability’, ‘complications’ and ‘infection’. Results We describe the novel indications for the use of penile prostheses, the significant advances in implant designs with improved mechanical reliability, the changing landscape of device infection, and the current management of complications. Sixty-eight publications with a grade A, B and C level of evidence are cited. Conclusion The clinical indications to implant a penile prosthesis have expanded beyond organic erectile dysfunction. With the many different devices currently available, the choice of which device to implant can be tailored based on an individual’s unique medical conditions, manual dexterity and expectations, and surgeon preference. There must be a conscious effort to prevent device infection, in the light of the development of increasingly virulent organisms. Penile prosthesis surgery is an integral part of the treatment of erectile dysfunction when non-surgical options fail or are contraindicated.09/2013; 11(3):245–253. DOI:10.1016/j.aju.2013.05.002
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ABSTRACT: Since their introduction 60 years ago, penile prostheses have remained the standard therapy for the management of refractory erectile dysfunction, with multiple long-term series reporting outcomes. A PubMed search was performed from 1990 to present, and outcomes of penile prosthetics were reviewed. Studies with <12 months follow-up were excluded. Overall mechanical survival of three-piece prostheses range from 81-94, 68-89 and 57-76% at 5, 10 and 15 years, respectively. Contemporary infection rates following recent device modifications are 1-2% (low risk) to 2-3% (high risk). Patient satisfaction ranges from 75-100% and varies by prosthetic device. Outcomes are further reviewed among specialized populations (revision surgery, Peyronie's disease, priapism, corporal fibrosis and neurologic impairments). Penile prostheses remain a viable surgical treatment option with excellent mechanical reliability, low infection rates and significant patient/partner satisfaction.Expert Review of Medical Devices 05/2013; 10(3):353-66. DOI:10.1586/erd.12.92 · 1.78 Impact Factor
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ABSTRACT: To evaluate the outcomes, the patients', and their partners' satisfaction concerning the AMS Spectra penile prosthesis implantation. Twenty-two unresponsive or dissatisfied patients with phosphodiesterase 5 inhibitor oral therapy or prostaglandin intracavernous injection underwent a Spectra penile prosthesis implantation. No major intraoperative or postoperative complications were observed. The preoperative erectile dysfunction (ED) was rated by the International Index of Erectile Function (IIEF) questionnaire. The patients and their partners were submitted to the IIEF and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaires through telephonic interviews at the third, sixth, and 12th months after the penile surgery. This study demonstrates that 86.4% of the patients and 52.6% of their partners are satisfied by the AMS Spectra penile prosthesis. The preoperative average IIEF score was equal to 28.5 (range 13-39). The postoperative IIEF rates were 47.7 (43-53), 51.8 (48-58), and 53.9 (50-58) at the third, sixth, and 12th months, respectively. The patient average EDITS score amounted to 39.5 (31-48), 43.4 (36-50), and 45.2 (38-50) at the third, sixth, and 12th months, respectively. The increase between the preoperative and postoperative IIEF parameters resulted to be statistically significant (P <.05) as well as the increase in EDITS at the third, sixth, and 12th months postoperatively. The AMS Spectra is a reliable device to treat ED as shown by the high grade of the patients' satisfaction. Moreover, the AMS Spectra is highly convenient in terms of cost savings in comparison to an inflatable device. In selected patients, this prosthesis should be considered as an effective solution to treat severe ED.Urology 06/2013; 82(2). DOI:10.1016/j.urology.2013.04.027 · 2.13 Impact Factor