[Effect of transderrmal testosterone on the quality of life of men with androgen deficiency and chronic prostatitis in routine clinical practice].

AIM: To evaluate the effect of Androgel on the quality of life of patients with androgen deficiency (hypogonadism) and chronic prostatitis in everyday practice.

MATERIALS AND

METHODS

This open multicenter observational non-interventional study comprised 401 men with testosterone deficiency and chronic prostatitis who were treated with topical applications of 1% testosterone gel of (Androgel) at a dose of 50 or 100 mg in routine clinical practice for three months. The primary endpoint was the health related quality of life. Also, the patients filled out AMS, I-PSS, NIH-CPSI questionnaires to assess the quality of life related to chronic prostatitis, lower urinary tract symptoms, and aging. Secondary endpoints included changes in the overall score of the International Index of Erectile Function (IIEF-5), changes in body weight and waist circumference, the reasons for treatment discontinuation and any adverse events that occurred during treatment.

RESULTS

Mean total testosterone levels at baseline and three months were 9.5 (95% CI 9.2-9.7) nmol/L and 16.5 (95% CI 16.1-16.9) nmol/l (p<0.001), respectively. There were statistically significant (p<0.001) differences in scores on all questionnaires. Mean scores at baseline and at three months for AMS, IIEF-5, I-PSS, NIH-CPSI questionnaires were 44.6 (95% CI 43.2-45.9) and 25.8 (95% CI 24.8-26.7); 12.7 (95% CI 12.2-13.2) and 19.3 (95% CI, 18.8-19.8); 14.5 (95% CI 13.7-15.3) and 5.6 (95% CI 5.2-6.1); 27.8 (95% CI 26,5-29.1) and 10.0 (95% CI 9.1-10.9), respectively. There were positive changes in body weight and waist circumference: at baseline and three months these parameters were 95 (95% CI 93.6-96.3) and 91.4 (95% CI 90.1-92.7) kg and 102.9 (95% CI 101.8-104.1) and 98.3 (95% CI 97.3-99.3) cm, respectively. No clinically significant adverse events were observed during follow-up.

CONCLUSIONS

Transdermal therapy with 1% testosterone gel (Androgel) is highly effective and safe in the management of androgen deficiency (hypogonadism). Its use in patients with chronic prostatitis and hypogonadism results in an improvement in low urinary tract symptoms, symptoms of chronic prostatitis, alleviates pelvic pain and thus leads to significant improvements in the quality of life.