Men with testosterone deficiency who take long-term testosterone-replacement therapy experience improvements in urinary and sexual function, as well as better quality of life, a registry study suggests. In addition, the data show no increase in risk for adverse events with the treatment.
Following 656 men with hypogonadism for up to 10 years, the researchers found that those who received testosterone therapy to physiological levels had significantly fewer urinary symptoms and were less likely to have erectile dysfunction, despite increases in prostate volumes.
The study, which was a collaboration between researchers from Boston University School of Medicine and Public Health and urologists in Germany, was published online in the Journal of Urology on July 18.
The results show that testosterone therapy “is well-tolerated, with progressive and sustained improvement in urinary and sexual function and overall improvement in quality of life,” lead author Abdulmaged Traish, PhD, department of urology, Boston University School of Medicine, Boston, Massachusetts, said in a press release.
Despite concerns that testosterone treatment may increase prostate size and lead to lower urinary-tract symptoms, these problems were not seen in the study group.
The observational, prospective, cumulative registry study included men who sought medical treatment for urological complaints. The men, who had a mean age of 60.72 years, had average total testosterone levels of ≤12.1 nmol/L and symptoms of hypogonadism at baseline.
Following an initial 6-week interval, 360 men received parenteral testosterone undecanoate (TU) 1000 mg every 12 weeks for up to 10 years. The 296 men who opted against having testosterone therapy served as controls for the analysis. The median follow-up in both groups was 8 years.
Analysis of baseline factors identified significant differences between men who did and who did not take testosterone therapy in terms of mean age and body mass index, scores on the International Index of Erectile Function and International Prostate Symptom Score (IPSS), prostate volume, prostate-specific antigen levels, concomitant medications, and quality of life on the Aging Males’ Symptoms scale (AMS).
To control for these differences, the researchers performed propensity matching, selecting 82 patients from each group matched for age, waist circumference, and body mass index.
The only significant baseline differences between the matched groups were in IPSS, at mean scores of 7.4 and 4.3 in the treated and untreated groups, respectively, in AMS, at mean scores of 53.8 and 40.6, respectively, and in their use of phosphodiesterase type 5 inhibitors (P < .0001 for all).
As expected, testosterone treatment restored testosterone levels to within the physiological range within the first year and remained at that level for the rest of the follow-up period.
Men treated with testosterone had sustained reductions in IPSS, particularly during the first 2 years, which remained statistically significant after adjustment for multiple confounding factors (P < .0001).
The proportion of treated patients who had mild symptoms, as defined by IPSS, increased from 50% to 100% over the course of the study, while the proportion deemed to have moderate symptoms decreased from 50% to 0%.
In contrast, control participants experienced modest increases in IPSS scores over the study period, with the proportion of patients in the moderate-symptom category increasing from 8.5% to 39.0%.
Men treated with testosterone had progressive and significant reductions in their postvoiding bladder volume (P < .0001), which decreased in line with changes in IPSS scores, while the mean postvoiding bladder volume increased among controls.
The team also found that there were significant improvements in erectile function among men given testosterone therapy (P < .0001), with the proportion of men with no erectile dysfunction increasing from 17.1% to 74.4%. Controls experienced a nonsignificant decrease in erectile function.
Similar to the IPSS, AMS scores decreased significantly among men treated with testosterone (P < .0001), particularly during the first 2 years, while those in the control group increased slightly.
Prostate volumes increased significantly in the testosterone-treated group over the study period, from 31.4 mL to 33.2 mL (P < .0001), while they remained unchanged in the control group. There was no effect of therapy on prostate-specific antigen levels.
There were no major adverse events in the testosterone-therapy group, compared with five deaths, eight nonfatal strokes, and eight nonfatal myocardial infarctions in the control group.
Discussing the balance between the risk and benefits of testosterone therapy, Dr Traish told Medscape Medical News that previous studies that linked the treatment with cardiovascular (CV) risk have been debunked, and numerous other studies show it is indeed protective against CV events.
To illustrate why it is unlikely that there should be a link between testosterone therapy and CV risk, he pointed out that the peak of testosterone levels in the body are between 22 and 45 years of age. “So why are we not dropping dead left and right from cardiovascular disease?”
For Dr Traish, the focus on the risk of CV events reflects a wider opposition to the use of testosterone therapy that is cultural in nature, not scientific, and results from a form of misplaced machoism.
He said: “We still have certain things in our society as taboo. That’s what this is. If we cross out the word testosterone and we call it whatever, people would have less of a problem with that.”
“But the fact that it has the word testosterone, from culture to culture, from age to age, it always has to acquire some form of negative connotation.”
He continued: “I’m a scientist. I really don’t believe that…If you look at it physiologically, from mechanistic perspective, this is really a fine biochemical tool that is trying to keep your engine clean, in a sense.”
Dr Traish reported no relevant financial relationships. Disclosures for the coauthors are listed in the paper.
J Urol. Published online July 18, 2017. Abstract
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