Prospective Evaluation of Patient Satisfaction, and Surgeon and Patient Trainer Assessment of the Coloplast Titan One Touch Release Three-Piece Inflatable Penile Prosthesis

Division of Sexual and Reproductive Medicine, Department of Urology, University of Michigan, Ann Arbor, MI, USA Department of Surgery, Division of Urology, University of Western Ontario, London, ON, Canada St. Peter's Hospital and the Institute of Urology, University College London, London, UK Carolina Urologic Research, Myrtle Beach, SC, USA Urology San Antonio, San Antonio, TX, USA Boston Medical Center, Boston, MA, USA Department of Urology, Rush University Medical Center, Chicago, IL, USA Department of Urology, School of Medicine, Emory University, Atlanta, GA, USA.
Journal of Sexual Medicine (Impact Factor: 3.15). 07/2012; 9(9):2467-2474. DOI: 10.1111/j.1743-6109.2012.02819.x
Source: PubMed

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: Abstract Objective. The aim of this study was to assess complication rates and patient satisfaction with Coloplast Titan® one-touch release (OTR) inflatable penile implants inserted at one university hospital centre between November 2008 and April 2011. Material and methods. Overall, 33 patients with organic erectile dysfunction underwent penile implant surgery during the study period. The Titan OTR inflatable penile implants were inserted using a penoscrotal approach. Patient and partner satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Results. One implant was removed because of infection, and three patients underwent revision surgery due to problems with autoinflation, deflation, and a displaced reservoir, respectively. In all cases the problems were solved and the implants were salvaged. Further complications included one patient with haematoma and sustained scrotal pain, one patient with meatal stenosis, and four patients with infections not related to the implant. In total, 30 EDITS questionnaires were administered and 26 (87%) were completed. Twenty-two patients (85%) reported being satisfied with the implant and two (8%) were dissatisfied. Twenty-four patients (92%) would recommend a penile implant to someone with a similar medical condition. Eighteen patients (72%) believed that their partner was satisfied with the implant. Nineteen patients (76%) felt that the process of achieving an erection with the implant was natural. Conclusion. Although it is important to inform patients about potential problems such as infection, pain and mechanical failure, the results show that inflatable penile implants are a good treatment choice for erectile dysfunction when conservative measures have failed.
    07/2013; DOI:10.3109/21681805.2013.808695
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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: OBJECTIVE To define and describe a type of pseudo-malfunction of the Coloplast Titan Inflatable Penile Prosthesis (IPP) One-Touch Release (OTR) pump (Coloplast Corp, Minneapolis, MN). MATERIALS AND METHODS We retrospectively reviewed a consecutive series of 550 patients with refractory organic erectile dysfunction who were implanted with a Coloplast Titan IPP with the OTR pump during a period of approximately 4 years. RESULTS All patients were implanted using standard techniques through an infrapubic or penoscrotal approach. Twenty-nine patients (5.3%) complained that their IPP would not inflate and that the pump bulb felt "hard." Examination revealed that their IPP was working normally; however, the inflate/deflate valve disc had become stuck in the deflate position. Very firm pressure had to be applied to the pump bulb to move the valve disc into the inflate position. Once this was accomplished, the device inflated and deflated normally. Another 14 patients (2.5%) reported this phenomenon to us but were able to apply enough pressure on the pump bulb to rectify it. CONCLUSION The inflate/deflate valve disc in the Coloplast Titan OTR pump can occasionally become stuck in the deflate position (7.8% of patients in our experience). Patients may be unable to inflate the device and return for evaluation. In all cases we have encountered, firm pressure on the pump bulb caused the valve to shift into the inflate position, and the device worked properly thereafter. Patients and implanting urologists should be aware of this issue and of the way in which it can be rectified. (C) 2014 Elsevier Inc.
    Urology 10/2014; 84(4):857-9. DOI:10.1016/j.urology.2014.06.012 · 2.13 Impact Factor