Can Androgel (testosterone) worsen Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS)?

Can Androgel Worsen BPH and LUTS?

Androgel (testosterone gel) does not worsen BPH or LUTS in most men, but requires monitoring in those with severe baseline symptoms. The most recent European Association of Urology guidelines (2025) state that testosterone therapy is safe and does not worsen LUTS or prostate volume significantly, except in men with severe symptoms, though long-term data remain limited 1.

Evidence from Guidelines

The 2025 EAU guidelines provide the most current guidance on this topic, explicitly stating that "several studies show that TTh is safe and does not worsen LUTS or prostate volume significantly except in men with severe symptoms" 1. This represents a significant shift from historical concerns about testosterone and prostate disease.

However, the FDA label for testosterone gel requires monitoring patients with BPH for worsening signs and symptoms 2. This creates a practical framework: testosterone therapy is generally safe but requires clinical vigilance, particularly in specific patient populations.

Who Can Safely Receive Testosterone Therapy

Men with mild-to-moderate LUTS/BPH can safely receive testosterone therapy with appropriate monitoring 1. The key distinction is symptom severity at baseline:

• Mild-to-moderate symptoms (IPSS <20): Testosterone therapy is safe and may even improve symptoms 1, 3
• Severe symptoms (IPSS ≥20): Exercise caution and consider more intensive monitoring 1

Monitoring Requirements

When prescribing Androgel to men with BPH, implement the following monitoring protocol:

• Baseline assessment: Document IPSS score, post-void residual volume, and prostate size 1, 2
• Early follow-up at 4-12 weeks: Reassess IPSS and evaluate for worsening obstructive symptoms 1
• Ongoing monitoring: Periodic assessment of PSA, IPSS, and clinical symptoms 2

The FDA specifically mandates monitoring for "worsening of signs and symptoms of BPH" in men receiving testosterone products 2.

The Paradox: Hypogonadism May Actually Worsen LUTS

Emerging evidence suggests that low testosterone itself may be a risk factor for LUTS/BPH, not testosterone replacement 4, 5. Research demonstrates that:

• Hypogonadism is associated with increased prostatic inflammation, which worsens LUTS 5
• Testosterone therapy may improve metabolic syndrome components that contribute to LUTS progression 5
• One randomized controlled trial showed IPSS decreased from 15.7 to 12.5 (p<0.05) after 12 months of testosterone therapy in hypogonadal men with BPH 3

This aligns with the "saturation model" of testosterone action on the prostate, where androgen receptors become saturated at relatively low testosterone levels, preventing further prostatic growth with testosterone replacement 6.

Clinical Decision Algorithm

For men with hypogonadism and BPH/LUTS:

1. Assess symptom severity using IPSS 1

   • IPSS 0-19: Testosterone therapy is safe; proceed with standard monitoring 1
   • IPSS ≥20: Consider more intensive monitoring or optimize BPH treatment first 1

2. Evaluate for absolute contraindications 2

   • Active urinary retention
   • Severe untreated BPH with complications (recurrent UTIs, bladder stones, renal insufficiency)

3. Initiate therapy with monitoring plan 2

   • Start Androgel at prescribed dose
   • Reassess at 4-12 weeks with repeat IPSS 1
   • Monitor PSA and clinical symptoms periodically 2

Common Pitfalls to Avoid

Do not withhold testosterone therapy solely based on BPH diagnosis 1, 4. The historical concern that testosterone universally worsens BPH is not supported by current evidence. Men with mild-to-moderate symptoms can safely receive treatment.

Do not ignore severe baseline symptoms 1. While testosterone therapy is generally safe, men with IPSS ≥20 require closer monitoring and may benefit from optimizing BPH treatment before or concurrent with testosterone initiation.

Do not assume worsening LUTS is due to testosterone 6. Natural progression of BPH occurs with aging independent of testosterone therapy. Any symptom changes should prompt comprehensive re-evaluation rather than automatic discontinuation of testosterone.

Reconciling Contradictory Evidence

The FDA warning label 2 appears to conflict with guideline recommendations 1, but this reflects regulatory caution rather than clinical evidence. The FDA requires monitoring language based on theoretical concerns, while clinical guidelines reflect actual outcomes data showing safety. The practical approach: prescribe testosterone when indicated, but implement the monitoring framework the FDA requires 2.