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SERUM ANDROGENS AND RISK OF LOWER URINARY TRACT SYMPTOMS IN COMMUNITY DWELLING OLDER MEN
526
THE JOURNAL OF UROLOGY®
METHODS: This was a multicenter, US based study of TU 750 mg injections given at baseline, at wk 4, and every 10 wks thereafter through 84 wks of treatment. Males q18 yrs of age with primary or secondary hypogonadism and a screening serum T concentration <300 ng/dL were eligible. Frequent blood sampling was collected during wks 14-24 (after 3rd injection) and wks 24-34 (after 4th injection). Trough T samples were collected at each injection visit. Extensive safety monitoring procedures included clinical laboratories, comprehensive prostate health, and adverse event (AE) assessments. RESULTS: 130 patients were enrolled, with >75% completing all injections during the treatment period. Patients average 54 yrs of age. Average 10 wk T concentrations during wks 14-24 were 494.6 ng/ dL (SD 141.46 ng/dL). T concentration profiles were similar for each injection interval (Figure 1), with peaks and nadirs nearly identical from one injection to the next, indicating consistent T replacement for these intervals. Average trough T concentrations were within normal range (300 to 1000 ng/dL) throughout the entire 21 mo treatment period. Injections were well tolerated. AEs reported were minor and nonserious; 36.7% of patients experienced at least one possibly treatment related AE during the study, with acne and increased prostate specific antigen (PSA) the most commonly reported events, reported in 6.2% and 5.4% patients, respectively. There were 7 (5.4%) patients with increased PSA, 3 (2.3%) patients with increased hematocrit and/or hemoglobin, and 2 (1.5%) patients diagnosed with prostate cancer during the 21 mo study period. CONCLUSIONS: This study demonstrates that TU 750 mg every 10 wks for 21 mo effectively provides consistent T concentrations within the normal range, a favorable safety profile and high level of patient tolerability. Figure 1: Mean (SD) serum total T concentrations after 3rd injection (wks 14-24) and 4th injection (wks 24-34) of TU 750 mg at steady state. (Horizontal lines are reference ranges for serum total T.)
Source of Funding: Indevus Pharmaceuticals
1470 SERUM ANDROGENS AND RISK OF LOWER URINARY TRACT SYMPTOMS IN COMMUNITY DWELLING OLDER MEN J. Kellogg Parsons*, Michael D Trifiro, Jaclyn Bergstrom, Kerrin Palazzi-Churas, Elizabeth Barrett-Connor, La Jolla, CA INTRODUCTION AND OBJECTIVES: Concern exists that androgen replacement therapy may potentially exacerbate male lower urinary tract symptoms (LUTS). However, associations of serum androgens with LUTS remain unclear. We evaluated serum androgens and risk of subsequent in a cohort of community dwelling older men. METHODS: From 1984 to 1987, we measured serum sex steroid hormone concentrations in participants in the Rancho Bernardo Study, a prospective, community-based study. In 2006, we administered the American Urological Association Symptom Index (AUA-SI) to surviving male participants. We utilized age-adjusted linear and logistic regression modeling to examine associations of serum total testosterone, bioavailable testosterone, dihydrotestosterone (DHT), and dehydroepiandrosterone (DHEAS) with AUA-SI. We defined a total AUA-SI q 8 points as clinically significant LUTS. We defined clinically significant urinary bother as a bother score > 3. RESULTS: Among 158 surviving participants with complete data,
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
at baseline the mean (SD) age was 58.3 (6.6) years and mean (SD) total testosterone was 309.7 (95.8) ng/dL. Mean (SD) period of follow-up prior to LUTS assessment was 20.3 (0.6) years. In age-adjusted linear regression, there were no significant associations of serum total testosterone (p=0.86), bioavailable testosterone (p=0.66), DHT (0.41), or DHEAS (p=0.87) with AUA-SI. In age-adjusted logistic regression, there were no significant associations of serum total testosterone (p= 0.99), DHT (p=0.41), or DHEAS (p=0.87) with clinically significant LUTS. There was a marginally significant trend toward decreased LUTS with increased bioavailable testosterone: compared to the first quartile, the age-adjusted odds ratios (OR) for LUTS were 0.61 (95% CI, 0.14-2.63, p = 0.51), 0.84 (95% CI, 0.23-3.10, p = 0.79), and 0.33 (95% CI, 0.11-1.04, p = 0.06) for the second, third, and fourth quartiles, respectively. There were no significant associations of serum total testosterone (p=0.86), bioavailable testosterone (p=0.66), DHT (0.41), or DHEAS (p=0.87) with urinary bother. CONCLUSIONS: In this cohort of older men, midlife levels of serum testosterone, DHT, or DHEAS did not predict the 20-year risk of clinically significant LUTS or urinary bother. There was a marginally significant trend toward decreased LUTS with increased bioavailable testosterone. These data suggest that serum testosterone is not associated with increased risk of LUTS. Further studies are needed to determine the effect of testosterone replacement therapy on LUTS risk. Source of Funding: None
1471 CORRELATIONS OF COUPLES’ RESPONSES FOLLOWING TREATMENT OF ERECTILE DYSFUNCTION Raymond C Rosen*, Watertown, MA; Patrick R Burns, Haoyue L Zeigler, Indianapolis, IN INTRODUCTION AND OBJECTIVES: Treatment of erectile dysfunction (ED) with PDE5 inhibitors has a documented benefit for the male. However, the impact on couples has received little systematic attention. This analysis assessed the correlation of changes in efficacy, satisfaction and sexual quality of life among men with ED with that of their female sexual partner. METHODS: In a blinded placebo-controlled trial, men with ED received tadalafil 5 mg once daily or placebo for 12 weeks. This retrospective analysis included correlations between changes from baseline in men’s responses to the Sexual Encounter Profile (SEP) diary questions SEP1 (successful erection), SEP2 (successful penetration), and SEP5 (overall satisfaction with sexual experience) and changes in their partners’ responses to similar diary questions regarding the male’s response. Also, correlations of couples’ responses to the Sexual Quality of Life (SQoL) and Treatment Satisfaction (THX) domains of the Sexual Life Quality Questionnaire (SLQQ) were assessed. Pearson correlation coefficients were calculated for each treatment group. RESULTS: In the tadalafil group, changes in men’s efficacy ratings (SEP1 and SEP2) were positively and highly correlated with changes in their partners’ efficacy ratings (pSEP1 and pSEP2) (r=0.89 and r=0.94, respectively). Changes in satisfaction with the overall sexual experience (SEP5), and SQoL domain positively correlated with changes in partners’ pSEP3 (r=0.64) and SQoL (r=0.57). Treatment satisfaction (THX) for men and their partners was positively correlated (r=0.62). Positive correlations among these variables were also noted in the placebo group. All correlations were statistically significant in both groups (p<0.001). CONCLUSIONS: Regardless of treatment group, men’s ratings of efficacy, satisfaction and sexual quality of life were highly concordant with their partner’s independent ratings. Disclaimer: Tadalafil is currently approved only for the treatment of erectile dysfunction.
THE JOURNAL OF UROLOGY®
METHODS: This was a multicenter, US based study of TU 750 mg injections given at baseline, at wk 4, and every 10 wks thereafter through 84 wks of treatment. Males q18 yrs of age with primary or secondary hypogonadism and a screening serum T concentration <300 ng/dL were eligible. Frequent blood sampling was collected during wks 14-24 (after 3rd injection) and wks 24-34 (after 4th injection). Trough T samples were collected at each injection visit. Extensive safety monitoring procedures included clinical laboratories, comprehensive prostate health, and adverse event (AE) assessments. RESULTS: 130 patients were enrolled, with >75% completing all injections during the treatment period. Patients average 54 yrs of age. Average 10 wk T concentrations during wks 14-24 were 494.6 ng/ dL (SD 141.46 ng/dL). T concentration profiles were similar for each injection interval (Figure 1), with peaks and nadirs nearly identical from one injection to the next, indicating consistent T replacement for these intervals. Average trough T concentrations were within normal range (300 to 1000 ng/dL) throughout the entire 21 mo treatment period. Injections were well tolerated. AEs reported were minor and nonserious; 36.7% of patients experienced at least one possibly treatment related AE during the study, with acne and increased prostate specific antigen (PSA) the most commonly reported events, reported in 6.2% and 5.4% patients, respectively. There were 7 (5.4%) patients with increased PSA, 3 (2.3%) patients with increased hematocrit and/or hemoglobin, and 2 (1.5%) patients diagnosed with prostate cancer during the 21 mo study period. CONCLUSIONS: This study demonstrates that TU 750 mg every 10 wks for 21 mo effectively provides consistent T concentrations within the normal range, a favorable safety profile and high level of patient tolerability. Figure 1: Mean (SD) serum total T concentrations after 3rd injection (wks 14-24) and 4th injection (wks 24-34) of TU 750 mg at steady state. (Horizontal lines are reference ranges for serum total T.)
Source of Funding: Indevus Pharmaceuticals
1470 SERUM ANDROGENS AND RISK OF LOWER URINARY TRACT SYMPTOMS IN COMMUNITY DWELLING OLDER MEN J. Kellogg Parsons*, Michael D Trifiro, Jaclyn Bergstrom, Kerrin Palazzi-Churas, Elizabeth Barrett-Connor, La Jolla, CA INTRODUCTION AND OBJECTIVES: Concern exists that androgen replacement therapy may potentially exacerbate male lower urinary tract symptoms (LUTS). However, associations of serum androgens with LUTS remain unclear. We evaluated serum androgens and risk of subsequent in a cohort of community dwelling older men. METHODS: From 1984 to 1987, we measured serum sex steroid hormone concentrations in participants in the Rancho Bernardo Study, a prospective, community-based study. In 2006, we administered the American Urological Association Symptom Index (AUA-SI) to surviving male participants. We utilized age-adjusted linear and logistic regression modeling to examine associations of serum total testosterone, bioavailable testosterone, dihydrotestosterone (DHT), and dehydroepiandrosterone (DHEAS) with AUA-SI. We defined a total AUA-SI q 8 points as clinically significant LUTS. We defined clinically significant urinary bother as a bother score > 3. RESULTS: Among 158 surviving participants with complete data,
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
at baseline the mean (SD) age was 58.3 (6.6) years and mean (SD) total testosterone was 309.7 (95.8) ng/dL. Mean (SD) period of follow-up prior to LUTS assessment was 20.3 (0.6) years. In age-adjusted linear regression, there were no significant associations of serum total testosterone (p=0.86), bioavailable testosterone (p=0.66), DHT (0.41), or DHEAS (p=0.87) with AUA-SI. In age-adjusted logistic regression, there were no significant associations of serum total testosterone (p= 0.99), DHT (p=0.41), or DHEAS (p=0.87) with clinically significant LUTS. There was a marginally significant trend toward decreased LUTS with increased bioavailable testosterone: compared to the first quartile, the age-adjusted odds ratios (OR) for LUTS were 0.61 (95% CI, 0.14-2.63, p = 0.51), 0.84 (95% CI, 0.23-3.10, p = 0.79), and 0.33 (95% CI, 0.11-1.04, p = 0.06) for the second, third, and fourth quartiles, respectively. There were no significant associations of serum total testosterone (p=0.86), bioavailable testosterone (p=0.66), DHT (0.41), or DHEAS (p=0.87) with urinary bother. CONCLUSIONS: In this cohort of older men, midlife levels of serum testosterone, DHT, or DHEAS did not predict the 20-year risk of clinically significant LUTS or urinary bother. There was a marginally significant trend toward decreased LUTS with increased bioavailable testosterone. These data suggest that serum testosterone is not associated with increased risk of LUTS. Further studies are needed to determine the effect of testosterone replacement therapy on LUTS risk. Source of Funding: None
1471 CORRELATIONS OF COUPLES’ RESPONSES FOLLOWING TREATMENT OF ERECTILE DYSFUNCTION Raymond C Rosen*, Watertown, MA; Patrick R Burns, Haoyue L Zeigler, Indianapolis, IN INTRODUCTION AND OBJECTIVES: Treatment of erectile dysfunction (ED) with PDE5 inhibitors has a documented benefit for the male. However, the impact on couples has received little systematic attention. This analysis assessed the correlation of changes in efficacy, satisfaction and sexual quality of life among men with ED with that of their female sexual partner. METHODS: In a blinded placebo-controlled trial, men with ED received tadalafil 5 mg once daily or placebo for 12 weeks. This retrospective analysis included correlations between changes from baseline in men’s responses to the Sexual Encounter Profile (SEP) diary questions SEP1 (successful erection), SEP2 (successful penetration), and SEP5 (overall satisfaction with sexual experience) and changes in their partners’ responses to similar diary questions regarding the male’s response. Also, correlations of couples’ responses to the Sexual Quality of Life (SQoL) and Treatment Satisfaction (THX) domains of the Sexual Life Quality Questionnaire (SLQQ) were assessed. Pearson correlation coefficients were calculated for each treatment group. RESULTS: In the tadalafil group, changes in men’s efficacy ratings (SEP1 and SEP2) were positively and highly correlated with changes in their partners’ efficacy ratings (pSEP1 and pSEP2) (r=0.89 and r=0.94, respectively). Changes in satisfaction with the overall sexual experience (SEP5), and SQoL domain positively correlated with changes in partners’ pSEP3 (r=0.64) and SQoL (r=0.57). Treatment satisfaction (THX) for men and their partners was positively correlated (r=0.62). Positive correlations among these variables were also noted in the placebo group. All correlations were statistically significant in both groups (p<0.001). CONCLUSIONS: Regardless of treatment group, men’s ratings of efficacy, satisfaction and sexual quality of life were highly concordant with their partner’s independent ratings. Disclaimer: Tadalafil is currently approved only for the treatment of erectile dysfunction.