Conclusion: Testosterone undecanoate 750 mg (AVEED) appears to be a well-tolerated and effective treatment for testos- terone-deficient men. Patients, on average, have testosterone values in the low normal range at nadir, however discontinuation rates in this cohort have been low. Disclosure: Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry. 158 BASELINE VALUES IN A STUDY OF ENCLOMIPHENE +/- DIET AND EXERCISE ON METABOLIC DYSFUNCTION Wyllie, M. 1 ; Mccullough, A. 2 ; Kim, E. 3 1 GPC Ltd, United Kingdom; 2 Urology, Albany; 3 Urology, Nashville Objective: Definition of baseline characteristics of men with secondary hypogonadism as a prelude to the evaluation of the impact of enclomiphene with and without diet and exercise on body mass and metabolism. This prospective study, coupled with existing long term registry data will increase our understanding of the impact of normalization of T on metabolic dysfunction. Material and Methods: Study ZA-205 is a randomized, double blind, placebo-controlled, multi-center study of men with sec- ondary hypogonadism evaluating the effect of treatment with enclomiphene along with diet and exercise. Obese subjects (BMI >30 and waist circumference 40 inches or more) between the ages of 18 and 60 are to have two assessments of testosterone (T) under 300ng/dL to randomize. 50 subjects are to be randomized. Results: Subjects meeting entry criteria had a mean screening T of 229ng/dL by commercial radioimmunoassay and/or 273ng/ dL when T was assessed by LCMS. 33 subjects had T by LCMS less than 300ng/dL. Using the free-T equilibrium method of calculation, 36 subjects had free-T less than 64pg/ml and the overall mean was 56pg/ml. All subjects had screening LH less than 9.4mIU/mL confirming secondary aetiology rather than primary. 95 subjects were screened to randomize 50 with a high T causing 29% of screen-failures. Almost half of the population (48%) reported at least 4 baseline symptoms. The most commonly reported symptoms were fatigue (96%), depression/ irritability/poor focus (74%), poor libido (58%) and muscle weakness (50%). Erectile dysfunction was less common (28%). Subjects had high percentage of body fat, 38.4% (25.3% - 51.9%). The Derogatis (DISF-SR) found subjects reported lower than average scores with about 36% considered to have sexual dysfunction. By the Impact of Weight QOL (IWQOL-Lite), subjects reported severe distress associated with obesity. All sub- sections of the SF-36 had averages well under US norms. Conclusions: Although the presenting symptomatology can be diverse, obese subjects with secondary hypogonadism are symp- tomatic. Treatment effect of enclomiphene and placebo along with diet and exercise will be assessed with regard to these symptoms after 6, 9 and 12 months of treatment. Long-term registry data has indicated a potential benefit of T normalization on various indices of metabolic dysfunction. Study ZA-205 will provide additional insight into the clinical potential of T normalization, at least via enclomiphene, as monotherapy and in conjunction with a diet and exercise programme. Disclosure: Work supported by industry: yes, by Repros Inc (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry. 159 COMPLICATION AND POST-SURGICAL INFECTION RATE IN AMERICAN MEDICAL SYSTEM’S INFLATABLE PENILE PROSTHESIS SURGERIES - A SINGLE SURGEON STUD Habibian, D.J.; Fazzari, M.; Katz, A.E.; Mellinger, B.C. Winthrop University Hospital, USA Objective: Inflatable penile prostheses (IPP) have high patient satisfaction rates, however early IPP models were associated with a high risk of complications, the most serious being prosthetic infection and its sequelae. The inhibizone coated AMS (Amer- ican Medical Systems) IPP and modifications in implantation procedure have significantly reduced the incidence of mechanical complication and prosthetic infection. The modified No Touch technique prevents contact between the implant and patient’s skin, uses fewer instruments, less disposable surgical material and less operative time but maintains a low infection rate. We report a single surgeon’s complication and infection rate with inhib- izone coated IPP implants via a modified “No Touch” technique. Methods: 214 men received an inhibizone coated AMS 3 Piece IPP between January 2006 and December 2015. The modified No Touch technique consisted of covering the penis with a plastic drape, frequent instrument rinsing and frequent glove change. Follow up consisted of routine office visits for 6 months and as needed thereafter. Complications were defined as any implant that required surgical revision. Co-morbidities were noted. Associations between patient risk factors and complica- tions were assessed via Fisher’s Exact test. P-values  0.05 were considered statistically significant. Results: The mean (median, SD) age was 63.5 (65, 12.5). Of 214 patients, 190 men received an AMS IPP as their primary implant. 19 had 1 previous implant (non AMS), 3 men had 2 previous procedures, and 2 men had 3 previous procedures. 1 primary implant experienced an infection (<1%). Two (<1%) primary implants eroded and explanted with no complications. There were no infections in our secondary implant cohort. 8 (3.6%) and 2 (<1%) men experienced mechanical malfunctions in our primary and secondary cohorts, respectively. No patients who received an AMS IPP as their third or fourth implant experienced complications. The infection rate for all patients was less than 0.5%. There was no association between comorbidities and complications. J Sex Med 2017;14:e1ee104 SMSNA Abstracts e65 Downloaded from https://academic.oup.com/jsm/article/14/Supplement_2/e65/6997742 by guest on 25 January 2023