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RESULTS: 33 patients have been enrolled so far. 12 months follow-up is available for 30 of them (15 in arm A, 15 in arm B). Questionnaire scores show better outcomes in terms of idividual and couple erotic function re-establishment in arm B (case group) at 3, 6 and 12 months. Patients in arm B ragained sexual activity earlier after surgery when compared to men in arm A. Patient and couple’s overall satisfaction rate is significantly higher in case group. Furthermore, it is interesting to note that, during the preoperative assessment, the psychosexual counsellor observed a remarkable cultural resistance, hard to win, expecially among female partners over 55 years. CONCLUSIONS: In our study, postoperative sexual activity and erotic function are better in patients undergone psychosexual counselling after PPI when compared to patients undergone only surgery. Source of Funding: None
1515 INCIDENCE OF PELVIC PAIN SYMPTOMS IN COMMUNITY- DWELLING YOUNG WOMEN AND RELATIONSHIP TO USE AND TYPE OF ORAL CONTRACEPTIVE PILLS Margarita Aponte*, New York, NY; Eva Fong, Auckland, New Zealand; Benjamin Brucker, Daniela Kaefer, Victor Nitti, Nirit Rosenblum, New York, NY INTRODUCTION AND OBJECTIVES: The oral contraceptive pill (OCP) has evolved with hormonal dosage reductions. The lowest estrogen OCPs decrease free testosterone and suppress estrogen production, with replacement of low concentrations of ethinyl estradiol which can lead to hypoestrogenic effects on vaginal tissue. The purpose of our study was to compare chronic pelvic pain symptoms (CPSS) between young women who are current OCP users and non⫺users. METHODS: An anonymous, internet⫺based survey was conducted in women aged 18⫺39 within two large university populations via list⫺serve emails. Women were excluded if they were pregnant, had a history of endometriosis or pelvic pain. We collected demographic data, type of OCP, duration of use and indication for usage. OCPs were classified by estrogen content into low⫺dose and normal ¨ 20 or ⬎20mcg). Subjects were classified as not taking OCP or dose (¡U taking a low or a high dose. Participants were asked to complete the NIH⫺CPSI questionnaire and were classified as having CPPS if their ´ 4. Outcomes were compared between total index pain score was ¡Y groups using SPSS and chi⫺square test. RESULTS: 1117 women responded to the survey and 932 were eligible, 605 women were non⫺OCP users and 327 were OCP users (169 low⫺dose and 171 normal dose). We found significant differences in the incidence of individual pelvic pain symptoms between OCP users and non⫺users and further differences with low⫺dose use. Overall low⫺dose OCP users were more likely to report pelvic pain symptoms and more likely to have CPPS than non⫺users (27.1% vs 17.5%, p⫽0.045). Conversely, normal dose OCP users were less likely to have pelvic pain symptoms overall than non OCP users. For ¡° pain or discomfort during or after sexual climax¡⫾low⫺dose OCP users had almost twice the incidence compared to controls (25.2% vs 12.3%, p⫽0.002), there was no difference between normal dose OCP users and controls. There was a trend towards low⫺dose OCP users having more perineal pain (15% vs 8.9%, p⫽0.054) and more pain during urination (14.3% vs 9.0%, p⫽0.096) than controls. 44% of respondents reported onset of pain after beginning OCP use and were more likely to fulfill CPPS criteria than those who had symptoms prior to OCP use (62% versus 30.3%, p⬍0.001). CONCLUSIONS: Low⫺dose OCPs appear to increase the incidence of CPPS and pain during sexual climax, while normal dose OCPs have similar incidence of CPPS to non⫺users and appear to be protective in individual pelvic pain symptoms. Source of Funding: None
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1516 THE REASON OF WITHDRAWAL FROM INTRACAVERNOSAL INJECTION TREATMENT Hyun Hwan Sung, Joong Seo Ahn, Sung Won Lee, Seoul, Korea, Republic of; Yoon Seok Suh*, Seol Ho Choo, Hyeon Jun Jang, , Korea, Republic of INTRODUCTION AND OBJECTIVES: Intracavernosal injection (ICI) treatment for erectile dysfunction (ED) was introduced earlier than phosphodiesterase 5 inhibitors (PDE5Is). ICI treatment still has been advocated as second line therapy for ED in many treatment algorithms since the introduction of PDE5Is. Despite high response rate of ICI treatment, withdrawal rate has been reported to be as high as 70⬃80%. There have been several factors associated with poor compliance from ICI treatment. However, there have been little data available about ICI treatment in the era of PDE5Is. The aim of this study was to investigate withdrawal rate and its reason from ICI treatment in patients with ED. METHODS: From the introduction of sildenafil in Korea, Oct 1999 to Dec 2011, all medical record of patients who have been prescribed with ICI treatment twice or more times were retrospectively reviewed. Medical record review and telephone survey on all patients were performed to investigate intercourse, withdrawal rate and its reason, adverse events, and satisfaction on sex life after ICI treatments. Satisfaction domain of the international index of erectile function questionnaire was used to ask satisfaction about overall sex life. RESULTS: During the period, 845 patients were prescribed with ICI treatments twice or more times. Of these, we were able to contact with 384 patients. Mean age was 59.3¡3⁄48.9 years with follow-up duration of 34.6¡3⁄447.2 months. After ICI treatments, 65.7% were able to intercourse, and withdrawal rate was 81.2%. The reason of withdrawal from ICI treatments were poor response (37.6%), inconvenience for use (18.2%), switch to other treatments (14.1%), adverse events (5.7%), high maintenance (5.7%), decreased libido (4.8%), and return of spontaneous erection (2.5%). Sixty-two patients switching treatments selected PDE5Is (60.7%) and insertion of penile prosthesis (21.3%). Adverse events occurred in the 25.5%, and which included pain (38.2%), priapism (28.4%), curvature (16.3%), plaque (11.4%), and subcutaneous hematoma (5.7%). In terms of adverse events, there was no difference between withdrawal (23.5%) and non-withdrawal group (34.8%, p⬎0.05). Satisfaction rate was higher in the treatmentcontinuing group than non-continuing group (satisfied plus moderately satisfied, 78.3 vs 37.3%, p⬍0.001). CONCLUSIONS: Withdrawal rate from ICI treatments was as high as 81.2%. The most common reason of withdrawal was poor response and inconvenience for use. However, treatment-continuing group was more satisfied with ICI treatment than non-continuing group. Before ICI treatments, sufficient counselling should be necessary. Source of Funding: None
1517 TESTOSTERONE REPLACEMENT THERAPY AND THE WORLD WIDE WEB: AN ASSESSMENT OF THE QUALITY OF INFORMATION Daniel T. Oberlin*, Puneet Masson, Robert E. Brannigan, Chicago, IL; Kevin T. McVary, Springfield, IL INTRODUCTION AND OBJECTIVES: Hypogonadism is the fastest growing condition in the United States and prescriptions for testosterone replacement therapy (TRT) are exponentially rising. Increasingly, many patients seek medical providers via the internet regarding TRT despite considerable variability in information quality and content. We reviewed how providers in large metropolitan areas promote TRT on their patient-oriented websites. METHODS: TRT provider websites were identified using Google search and the terms “testosterone replacement” and the name of the five most populous US cities (New York City, Los Angeles, Chicago, Houston, and Philadelphia). Providers websites were identified based on number of hits, with a minimum of 10 websites per region.
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These websites were assessed for 1) type of medical provider, 2) benefits of TRT, 3) risks associated with TRT, and 4) quality of information. RESULTS: The websites for 70 providers offering TRT were assessed. The distribution of provider websites per city included the following: NYC 15, LA 11, Chicago 16, Houston 16, Philadelphia 12. 24 out of 70 (34%) advertised TRT-clinics were directed by non-physicians, 34 (49%) were run by non-urology/non-endocrine physicians, and only 12 (17%) were urologist- or endocrinologist-managed. Overall, 14 out of 70 (20%) websites disclosed industry relationships. 95% of websites promoted the benefits to to include improved sex drive, cognitive improvement, increased muscle strength, or improved energy levels. Only 19/70 (27%) of all providers described any side effect of TRT. Websites directed by a urologist or endocrinologist were twice as likely to discuss risks of TRT (41% vs 20%, p ⫽0.05) compared to TRT clinic websites run by other providers. 15/70 (21%) of all websites actually refuted that TRT was associated with significant side-effects. 31% of provider websites run by a urologist or endocrinologist described gynecomastia as a potential risk of TRT versus 16% if run by other physicians or non-medical personnel; 7.1% refuted gynecomastia as a potential side effect of TRT. CONCLUSIONS: The majority of websites that promote TRT do not mention treatment risks. Urologists and endocrinologists are in the minority of providers promoting TRT on the internet, and are more likely to discuss potential risks compared to their counterparts. There is substantial variability in quality of content on TRT provider websites, which may contribute to misinformation regarding this expanding field. Patients seeking treatment for hypogonadism need to be accurately informed and counseled of the risks and benefits of TRT. Source of Funding: Havana Day Dreamers Foundation, SMSNA Fellowship Scholar 2012, SIU Urology Endowment Fund
1518 FACTORS INFLUENCING PATIENT DECISIONS TO INITIATE AND DISCONTINUE TESTOPEL姞 SUBCUTANEOUS TESTOSTERONE PELLETS FOR TREATMENT OF HYPOGONADISM Abhinav Khanna*, Saneal Rajanahally, Ryan Smith, Robert Coward, Jason Kovac, Marshall Gonzales, Larry Lipshultz, Houston, TX INTRODUCTION AND OBJECTIVES: A variety of modalities for testosterone replacement therapy (TRT) are available, including topical gels, injections, and Testopel姞 subcutaneous testosterone pellets (STP). STP are becoming more commonly utilized, but patient preferences and usage patterns surrounding this therapy remain poorly characterized. We sought to identify factors influencing patients’ decisions to initiate or discontinue STP and to describe their experiences with this modality. METHODS: A total of 175 men from a large academic urology clinic who were currently using or had previously used STP for hypogonadism received a 32-item electronic survey. Statistical analyses were performed using chi-square and Student’s t-test for categorical and continuous variables, respectively. Statistical significance was defined at p⬍0.05. RESULTS: One-hundred-one men (response rate 57.7%), mean age 51.4 (range 25-76), completed the survey. Forty-nine (48.5%) and 40 (39.6%) men switched to STP from topical gel and injection therapy, respectively, while 12 (11.9%) men initially started TRT with STP. Convenience (80.4%) was the most important factor in patients’ decision to start STP, while cost of the previous form of TRT (29.9%) was least important. Physician recommendation (81.3%) and possible transference to others (50%) were the most common reasons to switch to STP from a gel, while the gel characteristics (33.4%) were the least common. Similarly, users switching from injection therapy cited physician recommendation regarding STP (80.0%) as their primary reason for initiating STP therapy, while pain of injections (32.5%) was the least common. At the time of the survey, 31 men (31.9%) had
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stopped using STP. Of these, 15 (48.4%) went back to a previously used method, 8 (25.8%) switched to a previously unused method, and 8 (25.8%) stopped using TRT completely. Cost of therapy (60.0%) was the primary factor in discontinuing STP. There was no difference in serum testosterone levels between men who continued STP and those who discontinued them (704.9 vs 757.6 ng/dL, p ⫽ 0.53). CONCLUSIONS: Convenience is the most important factor in a patient’s decision to initiate STP; however, physician recommendation also plays a substantial role. Despite the potential disadvantages of gel and injection therapies, patients do not cite these as primary reasons for switching to STP. Cost was the primary factor in discontinuing STP. STP is a viable treatment option for hypogonadal men seeking an easy and dependable alternative modality of TRT. Source of Funding: None
1519 VITAROS姞 EFFICACY AND SAFETY IN VIAGRA姞 NON-RESPONDERS WITH LONGER TERM USE John Mulhall*, New York, NY; Jacques Buvat, Lille, France; Irwin Goldstein, Bassam Damaj, Daniel Frank, Ysabella Fernando, San Diego, CA INTRODUCTION AND OBJECTIVES: Vitaros姞 (alprostadil topical cream) is a novel erectogenic therapy, applied topically to the urethral meatus. The efficacy and safety of Vitaros姞, was tested in erectile dysfunction (ED) patients in Phase 3 clinical trials including men who had previously taken the phosphodiesterase type 5 (PDE-5) inhibitor, Viagra姞. Efficacy after twelve weeks and longer term use was evaluated to determine whether Vitaros姞 may sustain erectile function in men previously unresponsive to PDE-5 inhibitors. METHODS: Initially, a twelve-week trial treated 1732 patients with placebo or three dose levels of Vitaros (100, 200, 300 mcg). Of these, 325 patients had a history of Viagra姞 use but discontinued due to no or low efficacy. Patients completed the international index of erectile function (IIEF) at multiple time points. Subsequently, an openlabel flexible dose trial (planned for twelve months) enrolled the same patients to assess longer-term safety and efficacy. Patients were given eight doses of Vitaros姞 200 mcg dose and then permitted to choose their dose for the remainder of the study. Of the 325 Viagra-failure patients, ⬎70% continued in the open label trial. The IIEF erectile function (EF) domain score was compared between baseline and after twelve weeks of treatment and the patient’s last visit in the open-label trial. Safety was evaluated in patients receiving at least one dose. RESULTS: After twelve weeks, the mean change in IIEF EF domain score was greater for the treatment groups (ranging from 1.2-1.6 as compared to placebo (-0.9). This increase in the IIEF-EF was enhanced with longer treatment in the open-label trial. The dose most commonly chosen by the patients was 300 mcg. Although individual variability occurred, the IIEF-EF tended to increase with time, especially in those patients with IIEF-EF scores ⬎10. The adverse events reported in this subset of patients were mild to moderate local reactions not markedly different from the overall trend in the remaining safety population. Additionally, the incidence of AE reports decreased with repeated exposure. CONCLUSIONS: In general, Vitaros姞 200 and 300 mcg doses showed improved erections in this population and adverse events were limited, decreasing with repeated exposure. Therefore, Vitaros姞 may be a viable treatment option for those patients previously unresponsive to PDE-5 inhibitors. Source of Funding: Private Industry