Andrew R McCullough

Albany Medical College, Albany, New York, United States

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Publications (48)94.96 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Provoked and spontaneous nocturnal erections are thought to play a role in maintenance of male sexual health through oxygenation of the corpus cavernosa. Conversely, hypoxia is thought to be an etiological factor in the pathogenesis of cavernosal fibrosis and long-term erectile dysfunction. It has been hypothesized that the early penile hypoxia after radical prostatectomy (RP) may lead to fibrosis and consequently a decrease in stretched penile length and long-term erectile dysfunction. The aim of this study was to assess the changes in penile tissue oxygenation with vacuum erection device (VED) use. Twenty men between 2 and 24 months following RP were enrolled prospectively. Each man cycled a VED to achieve full erection 10 consecutive times over a period of approximately 2 minutes without constriction ring. Tissue oximetry was measured at baseline and immediately after VED using a tissue oximeter at five sites: right thigh, right corpora, glans, left corpora, and left thigh. Additional measurements were captured over the course of an hour. Mean age and time from surgery was 58.2 years and 12.6 months, respectively, and the average Sexual Health Inventory for Men score was 7. Use of the VED significantly increased both glanular and corporal oximetry relative to the baseline values for the entire 60 minutes. An initial increase of 55% was seen in corporal oxygenation with VED use. This is the first study demonstrating that a single, brief application of the VED without a constriction ring results in significant improvement in penile oxygen saturation. The use of a VED has significant benefits for patients both with regard to cost and invasiveness when compared with other penile rehabilitation protocols. Welliver RC Jr, Mechlin C, Goodwin B, Alukal JP, and McCullough AR. A pilot study to determine penile oxygen saturation before and after vacuum therapy in patients with erectile dysfunction after radical prostatectomy. J Sex Med **;**:**-**.
    Journal of Sexual Medicine 02/2014; · 3.51 Impact Factor
  • Clay W Mechlin, Jason Frankel, Andrew McCullough
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    ABSTRACT: Current U.S. Food and Drug Administration-approved therapies for hypogonadism involve testosterone (T) replacement. Testosterone pellets (TP) require a minor office procedure every 3 to 4 months. The need for repeated insertions increases the likelihood of a complication. Anastrozole (AZ) is an aromatase inhibitor that has been used off-label for the treatment of male hypogonadism. AZ increases T levels by lowering serum estradiol (E2) levels and increasing gonadotropin (GTP) levels. We hypothesized that the concomitant use of AZ with TP insertions would sustain therapeutic T levels and increase the interval between TP insertions. Men treated with TP for hypogonadism at an academic center were offered AZ (1 mg/day) at the time of TP reinsertion as a way of potentially decreasing the frequency of TP insertions. Total T (TT), free T (FT), sex hormone binding globulin, E2, luteinizing hormone (LH), and follicle-stimulating hormone FSH levels were obtained prior to T replacement and at 6 and 15 weeks from TP insertion. Men were re-implanted at 16 weeks if their TT levels were less than 350 ng/dL and their symptoms recurred. We retrospectively reviewed our records of men who underwent TP, TP, and AZ from 2011 to 2012. Demographics, TT, FT, LH, FSH, and E2 levels were recorded. Data were analyzed with anova and a Tukey's test. TT level at 6, 15, or >15 weeks from TP insertion. Thirty-eight men with 65 insertions were analyzed. The TP AZ group had significantly higher TT and FT levels than the TP group at >120 days (P < 0.05). The TP group had significantly higher E2 levels at all time points (P < 0.01). GTP levels remained stable in the TP AZ group. Average time to reinsertion in TP AZ was 198 days vs. 128 days in the TP group. Men on TP AZ maintain therapeutic T levels longer than men on TP alone and have significantly less GTP suppression. Mechlin CW, Frankel J, and McCullough A. Coadministration of anastrozole sustains therapeutic testosterone levels in hypogonadal men undergoing testosterone pellet insertion. J Sex Med **;**:**-**.
    Journal of Sexual Medicine 10/2013; · 3.51 Impact Factor
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    ABSTRACT: Aim: Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods: This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; '100/200-mg' group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF). Results: Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty-five per cent (112/172) of 'nonresponders' to avanafil 100 mg responded to the 200-mg dose. The most common (≥ 2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events. Conclusions: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.
    International Journal of Clinical Practice 04/2013; 67(4):333-41. · 2.43 Impact Factor
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    ABSTRACT: Implantable testosterone pellets were approved by the Food and Drug Administration in 1972 for the treatment of testosterone deficiency syndrome (TDS). Clinical use of this testosterone delivery modality has been limited until its recent reintroduction (Testopel(®) , Slate Pharmaceuticals, Durham, NC, USA). Six academic institutions collaborated and combined their databases to more fully characterize serum testosterone levels after the pellet implantations. To assess the time-dependent serum testosterone levels after subcutaneous testosterone pellets in clinical practice for the treatment of TDS. Data were retrospectively pooled and analyzed from data in six academic institutions. Variables included patient age, total testosterone concentrations before and after implantation, the number of testosterone pellets implanted, and the time from implantation to measurement of serum testosterone concentrations. Three hundred eighty men undergoing 702 insertions were included for analysis using JMP (version 4.0.4; SAS Institute, Cary, NC, USA). Main outcome measures were postimplantation total testosterone levels and investigator-reported adverse events. Testosterone levels as a function of the number of pellets implanted and time from implantation were assessed. Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month postimplantation and sustained therapeutic levels (>300) for 4-6 months. Higher pellet numbers (10-12 pellets) were associated with higher, more consistent, and longer maintenance of testosterone levels within the therapeutic range. Four extrusions and three hematomas were reported early in our experience; other investigator-reported adverse events were generally mild to moderate in nature and transient in duration. No subjects required analgesics. Testosterone pellets (Testopel(®) , Slate Pharmaceuticals) provide sustained levels of testosterone for at least 4 months and up to 6 months in men with TDS. Implantation of ≥8 pellets achieved optimal results with respect to peak mean testosterone level and duration of effect. Testosterone pellets were generally well tolerated.
    Journal of Sexual Medicine 02/2012; 9(2):594-601. · 3.51 Impact Factor
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    ABSTRACT: Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED). To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED. In this multicenter, double-blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30 minutes prior to initiation of sexual activity. At least a 12-hour separation time between doses was required; no restrictions were placed on food or alcohol intake. Improvement in erectile function (EF) was measured by Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3) and by the EF domain of the International Index of Erectile Function (IIEF) questionnaire. Mean change in percentage of successful sexual attempts (SEP2 and SEP3) and IIEF-EF domain score significantly favored all doses of avanafil over placebo (P ≤ 0.001). Secondary analyses demonstrated achievement of successful intercourse by subjects within 15 minutes of dosing. Of the 300 sexual attempts made during this interval, 64% to 71% were successful in avanafil-treated subjects compared with 27% in placebo-treated subjects. Successful intercourse was also demonstrated >6 hours post dosing, with 59% to 83% of the 80 sexual attempts successful in avanafil-treated subjects compared with 25% of placebo-treated subjects. The most commonly reported adverse events in subjects taking avanafil included headache, flushing, and nasal congestion; there were no drug-related serious adverse events. Following 12 weeks of avanafil treatment without food or alcohol restrictions, significant improvements in sexual function were observed with all 3 doses of avanafil compared with placebo. Successful intercourse was observed as early as 15 minutes and >6 hours after dosing in some subjects. Avanafil was generally well tolerated for the treatment of ED.
    Journal of Sexual Medicine 01/2012; 9(4):1122-33. · 3.51 Impact Factor
  • Sidney Glina, William J Sommers, Andrew R McCullough
    Journal of Sexual Medicine 02/2011; 8(2):337-40. · 3.51 Impact Factor
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    ABSTRACT: To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy. We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length. Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points. This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery.
    The Journal of urology 06/2010; 183(6):2451-6. · 4.02 Impact Factor
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    ABSTRACT: Prostate cancer is common and is being diagnosed in younger men now compared with two decades ago. Long-term functional outcomes are of significant importance to patient and impact upon the patient decision-making process regarding choice of therapy. Erectile function preservation (rehabilitation) has gained significant traction worldwide despite the absence of definitive evidence in its favor. To define the role of rehabilitation in the prostate cancer patient who has undergone radical prostatectomy (RP). A committee of five experts in the field from three countries was convened, and using a thorough analysis of the literature and the Delphi approach to expert opinion, recommendations were arrived at for clinicians treating men with prostate cancer before and after definitive surgical management. Recommendations arrived at included: that clinicians should discuss prevalence rates, the pathophysiology of erectile dysfunction after RP and the predictors of erectile function recovery, that validated instruments should be used using the published cut-offs for normalcy, that rehabilitation be discussed with patients, and that they be informed that significant potential benefits may be associated with rehabilitation. The International Consensus of Sexual Medicine (ICSM) 2001 committee on rehabilitation after radical prostatectomy recommended that a discussion occur regarding rehabilitation in all patients undergoing or who have undergone RP. However, the committee recognized the absence of definitive data to date and could not comment on the optimal approach to rehabilitation at this time.
    Journal of Sexual Medicine 04/2010; 7(4 Pt 2):1687-98. · 3.51 Impact Factor
  • Journal of Urology - J UROL. 01/2010; 183(4).
  • Andrew McCullough
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    ABSTRACT: Erectile dysfunction (ED) is a common sequela of the treatment of prostate cancer that negatively impacts quality of life. Though the phosphodiesterase inhibitors (PDE5i) are popular for the treatment of ED because of their ease in administration, they are frequently ineffective after surgery and radiation therapy for prostate cancer. Intracavernosal therapy (ICT) was the first effective medical therapy for erectile dysfunction and is the most effective therapy for post-treatment ED. Patient and physician resistance contributes to its low acceptance despite its clear superior efficacy. The rationale for the use of ICT in the treatment and possible prevention of ED after prostate cancer therapy is presented along with strategies for facilitating its implementation. KeywordsErectile dysfunction–prostate cancer–erectile dysfunction–injection therapy
    02/2009: pages 197-207;
  • Journal of Urology - J UROL. 01/2009; 181(4):164-164.
  • Journal of Urology - J UROL. 01/2009; 181(4):487-487.
  • Journal of Urology - J UROL. 01/2009; 181(4):486-487.
  • Journal of Urology - J UROL. 01/2009; 181(4):525-525.
  • Journal of Urology - J UROL. 01/2009; 181(4):486-486.
  • Andrew McCullough
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    ABSTRACT: Dr. Patrick Walsh's description of nerve-sparing prostatectomy was an important landmark in the surgical treatment of prostate cancer. Despite the dramatic improvement in postoperative potency rates, anecdotal reports of penile size loss were increasingly reported by patients. Experimental studies in animals revealed penile fibrosis and corporal cavernosal smooth muscle apoptosis after cavernosal nerve ablation. After an observational cross-sectional study demonstrated a time-dependent loss of penile length and circumference in men presenting with erectile dysfunction after nerve-sparing prostatectomy, several prospective studies supported the observational study. A prospective penile biopsy study before and after surgery demonstrated replacement of corporal smooth muscle with collagen and provided a possible explanation for loss of penile length. The mechanism has not yet been elucidated. This article reviews in detail the existing studies on loss of penile size after prostatectomy and possible etiologic mechanisms.
    Current Urology Reports 12/2008; 9(6):492-9.
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    ABSTRACT: Erectile dysfunction (ED) after radical prostatectomy (RP) has a significant negative impact on a patient's health-related quality of life. Phosphodiesterase type 5 inhibitors (PDE5-Is) have recently been utilized not only as a treatment of ED in this population but also as a preventive strategy in penile rehabilitation programs. To elucidate the pathophysiologic mechanisms of post-RP ED, to assess the need for rehabilitation following surgery, and to analyze the basic scientific evidence and clinical applications of PDE5-Is for the prevention and treatment of ED. A systematic review of the literature using Medline, Cancerlit, and the Cochrane Library was conducted for the period between January 1997 and June 2008 using the keywords erectile dysfunction, radical prostatectomy, and phosphodiesterase inhibitors. Efficacy and safety of PDE5-Is in the randomized, placebo-controlled trials are evaluated in this review, and the limitations of the remaining studies are also discussed. Post-RP ED has many factors. Cavernosal nerve injury induces pro-apoptotic factors (ie, loss of smooth muscle) and pro-fibrotic factors (ie, an increase in collagen) within the corpora cavernosa. Cavernosal changes may also be attributed to poor oxygenation due to hemodynamic changes. Experimental data support the concept of cavernosal damage and suggest a protective role for daily dosage of a PDE5-I; however, similar data have not yet been replicated in humans. Penile rehabilitation programs are common in clinical practice, but there is no definitive evidence to support their use or the best treatment strategy. PDE5-Is are efficacious and safe in young patients with normal preoperative erectile function who have undergone bilateral nerve-sparing radical prostatectomy. On-demand use of a PDE5-I may be at least as efficacious as daily use. PDE5-I use in penile rehabilitation programs is not supported by rigorous level 1 evidence-based medicine. PDE5-Is are an efficacious and safe treatment for post-RP ED in properly selected patients. The experimental results on the protective role of daily dosages of PDE5-Is, while robust, have not been replicated in humans. With current human data, the role of a PDE5-I alone as a rehabilitation strategy is unclear and deserves further investigation.
    European Urology 11/2008; 55(2):334-47. · 10.48 Impact Factor
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    ABSTRACT: To clarify the period of responsiveness to sildenafil. Under a double-blind protocol, men with mild to moderate erectile dysfunction (International Index of Erectile Function [IIEF] Erectile Function domain score, 11 to 25) were randomized to sildenafil (100 mg) or placebo and attempted intercourse 8 hours (range, 7 to 9 hours) postdose (first 4-week phase) and 12 hours (11 to 13 hours) postdose (second 4-week phase after treatment crossover). The primary outcome was the per-patient proportion (PPP; least squares means [95% confidence interval]) of affirmative responses to the Sexual Encounter Profile question 3 (SEP3: "Did your erection last long enough for you to have successful intercourse?"). For sildenafil (n = 174) versus placebo (n = 177), baseline values were similar but the PPP of successful intercourse attempts increased to 76% (69% to 82%) versus 50% (43% to 57%) in phase 1 (odds ratio [OR] = 3.2) and 79% (72% to 85%) versus 52% (44% to 60%) in phase 2 (OR = 3.5), and the PPP of Erection Hardness Score 4 erections (completely hard and fully rigid) was 41% (34% to 48%) versus 10% (7% to 15%) in phase 1 (OR = 6.2) and 44% (37% to 51%) versus 17% (12% to 23%) in phase 2 (OR = 4.0). Thus, at 12 hours, the odds of successful intercourse tripled and of a completely hard erection quadrupled. The sildenafil group achieved greater (P <0.001) PPP of successful penetration (SEP2), satisfaction with erection hardness (SEP4), and satisfaction with the sexual experience (SEP5); improvement in IIEF domain scores; and treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction. In men with mild to moderate ED, responsiveness to sildenafil may persist much longer than 4 hours.
    Urology 05/2008; 71(4):686-92. · 2.42 Impact Factor
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    Herbert Lepor, Andrew McCullough
    Reviews in urology 02/2008; 10(1):1-5.
  • Andrew R McCullough, Laurence A Levine, Harin Padma-Nathan
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    ABSTRACT: After bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), nocturnal and sexually mediated erections may help to preserve normal erectile function (EF). To investigate nocturnal penile tumescence and rigidity (NPTR) in a subset (N = 54 men) from a randomized, double-blind trial (N = 76) of nightly sildenafil after BNSRRP. Inclusion required preoperative "normal" EF (defined as a combined score of >/=8 for International Index of Erectile Function questions 3 (penetration) and 4 (maintained erection after penetration) and NPTR testing (>/=10 continuous minutes of >/=55% rigidity [R >/= 55%] at the base). Postoperative assessments were at weeks 4 (pretreatment), 16, 28, 40 (during 36 weeks of nightly prophylaxis: sildenafil 50 mg [N = 17], 100 mg [N = 18] or placebo [N = 19]), and 48 (after 8 weeks of no erectile dysfunction therapy, when "responders" were delineated by the defined normal EF and a "yes" response to "Over the past 4 weeks, have your erections been good enough for satisfactory sexual activity?"). Base and tip rigidity and tumescence were measured using penile plethysmography. Duration of R >/= 55% and area under the curves for rigidity and tumescence. Postoperatively, rapid profound reduction in nocturnal EF was noted in all groups. There was a gradual dose-dependent improvement in base and tip rigidity in the sildenafil groups but little improvement in the placebo group. Eight weeks after treatment termination (48 weeks postoperatively), 24% (4/17) of 50-mg sildenafil recipients, 33% (6/18) of 100-mg sildenafil recipients, and 5% (1/19) of placebo recipients were responders. Tip R >/= 55% was the most discriminating NPTR measure between nonresponders and responders to sildenafil, in whom it regained baseline (preoperative) levels (whereas base R >/= 55% did not). It was most prolonged in responders to sildenafil 100 mg. In our subset analysis, nightly sildenafil for 9 months post-BNSRRP objectively improved nocturnal erections and pharmaceutically unassisted EF.
    Journal of Sexual Medicine 02/2008; 5(2):476-84. · 3.51 Impact Factor

Publication Stats

941 Citations
94.96 Total Impact Points

Institutions

  • 2012
    • Albany Medical College
      Albany, New York, United States
  • 2011
    • Ellis Hospital
      Schenectady, New York, United States
  • 2005–2011
    • CUNY Graduate Center
      New York City, New York, United States
    • Università Vita-Salute San Raffaele
      Milano, Lombardy, Italy
  • 2010
    • NYU Langone Medical Center
      New York City, New York, United States
  • 2008
    • George Washington University
      Washington, Washington, D.C., United States
    • Gracie Square Hospital, New York, NY
      New York City, New York, United States
  • 2005–2007
    • Albert Einstein College of Medicine
      • Department of Urology
      New York City, New York, United States
  • 2002
    • State University of New York Downstate Medical Center
      • Department of Urology
      Brooklyn, NY, United States
  • 2001
    • New York University
      • Department of Urology
      New York City, NY, United States