title: Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors: Division of Sexual and Reproductive Medicine, Department of Urology, University of Michigan, Ann Arbor, MI, USA. daohl@med.umich.edu
authors: Dana A
authors: DA
authors: Ohl
authors: Gerald
authors: G
authors: Brock
authors: David
authors: D
authors: Ralph
authors: William
authors: W
authors: Bogache
authors: Leroy
authors: L
authors: Jones
authors: Ricardo
authors: R
authors: Munarriz
authors: Laurence
authors: L
authors: Levine
authors: Chad
authors: C
authors: Ritenour
mesh_terms: D001291:Attitude of Health Personnel; D002983:Clinical Competence; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D015917:Penile Prosthesis; D011446:Prospective Studies; D011474:Prosthesis Design