Is testosterone replacement therapy a contraindication for patients with benign prostatic hyperplasia (BPH)?

Testosterone Replacement Therapy is NOT an Absolute Contraindication for Benign Prostatic Hyperplasia

Testosterone replacement therapy (TRT) can be safely used in men with benign prostatic hyperplasia (BPH), as multiple studies demonstrate no significant worsening of voiding symptoms, urinary retention rates, or quality of life despite modest increases in prostate volume. 1

Evidence Supporting Safety in BPH

The most authoritative guideline evidence directly addresses this concern:

• Multiple studies have failed to demonstrate exacerbation of voiding symptoms attributable to BPH during testosterone supplementation, and complications such as urinary retention have not occurred at higher rates than in controls receiving placebo 1

• Prostate volume does increase significantly during TRT, mainly during the first six months, reaching levels equivalent to men without hypogonadism 1

• Despite increased prostate volume, urine flow rates, post-voiding residual urine volumes, and prostate voiding symptoms did not change significantly 1

• This apparent paradox is explained by the poor correlation between prostate volume and urinary symptoms 1

Current Guideline Recommendations

The most recent 2025 European Association of Urology guidelines provide clear direction:

• TRT is safe and does not worsen lower urinary tract symptoms (LUTS) or prostate volume significantly except in men with severe symptoms 1

• The evidence has limited long-term data, but available studies support safety 1

Clinical Algorithm for TRT in BPH Patients

Baseline Assessment Required:

• Determine baseline voiding history using a standardized questionnaire 1
• Perform digital rectal examination 1
• Measure PSA levels (biopsy if PSA >4.0 ng/ml or abnormal DRE) 1
• Assess severity of LUTS symptoms 1

Decision Framework:

Proceed with TRT if:

• Mild to moderate BPH symptoms 1
• Normal or stable PSA 1
• No evidence of prostate cancer 1

Exercise caution or defer TRT if:

• Severe untreated LUTS 1
• History of urinary retention 1
• Significantly elevated PSA requiring further evaluation 1

Monitoring Protocol:

• Assess urinary symptoms at 3-6 months initially, then annually 1
• Monitor PSA every 3-6 months for the first year, then annually 1
• Perform digital rectal examination at each monitoring visit 1
• Consider prostate biopsy if PSA rises >1.0 ng/ml in any year or if DRE shows changes 1

Important Caveats

Individual variation exists: While population studies show no increased symptoms, clinicians should be aware that individual men with hypogonadism may occasionally have increased voiding symptoms with TRT 1

Distinguish from prostate cancer: The FDA label notes that geriatric patients treated with androgens may be at increased risk of developing prostatic hypertrophy and prostatic carcinoma, although conclusive evidence to support this concept is lacking 2, 3

Severe BPH requires caution: The FDA label specifically warns that patients with benign prostatic hypertrophy may develop acute urethral obstruction, and if this occurs, the androgen should be stopped 2, 3

Contrast with Prostate Cancer

It's critical to distinguish BPH from prostate cancer as a contraindication:

• Prostate cancer (active or untreated) remains an absolute contraindication per European Association of Urology guidelines 4
• BPH, in contrast, is not listed as an absolute contraindication in current guidelines 1, 4
• The TRAVERSE trial confirmed no difference in prostate cancer incidence between testosterone and placebo groups at 33-month follow-up 1