Can testosterone therapy cause an enlarged prostate?

Testosterone therapy can modestly increase prostate volume, but trials have not linked that change to worse urinary symptoms in deficient men. In a 2022 trial of men awaiting BPH surgery, total prostate volume rose 2.64 mL in testosterone-deficient men given testosterone, while the adenoma did not grow significantly. Symptom improvement was the same as on placebo.

Does TRT make BPH symptoms worse?

TRT did not make BPH symptoms worse in the largest trial or in two meta-analyses. In TRAVERSE, the change in International Prostate Symptom Score did not differ between testosterone gel and placebo in 5204 men. The FDA label still advises monitoring men with BPH because the trials excluded men with severe symptoms.

Can TRT cause urinary retention?

Acute urinary retention on TRT was rare and not significantly more common than on placebo in TRAVERSE. It occurred in 20 men on testosterone (0.77%) and 16 on placebo (0.61%), a hazard ratio of 1.25. Being unable to pass urine is an emergency on or off testosterone.

Can you take TRT if you already have BPH?

Men with BPH and mild or moderate symptoms were included in TRAVERSE, and their symptoms did not worsen more than on placebo. Men with an IPSS above 19 or a PSA above 3.0 ng/mL were excluded, so evidence for severe BPH is limited. A prescriber should check symptoms and PSA before and during treatment.

Does testosterone raise PSA?

Testosterone raises PSA slightly, mainly in the first year of treatment. In TRAVERSE, PSA rose an extra 0.15 ng/mL on testosterone compared with placebo at 12 months. After month 12 the difference between groups was no longer statistically significant.

Is injectable testosterone better or worse for the prostate than gel?

No delivery route clearly worsened urinary symptoms in a 2024 network meta-analysis of 21 trials and 2453 men. Long-term injections were linked to lower IPSS scores, while short-term injections were linked to a larger prostate volume. The differences between routes were not significant overall, so route choice usually depends on other factors.

Why does the TRT label warn about BPH if the trials look reassuring?

The TRT label warns about BPH because androgens can stimulate prostate growth and the label must cover every patient, not only trial participants. The AndroGel 1.62% label states that men with BPH on androgens are at increased risk of worsening symptoms. The trials studied screened men with low-risk prostates, which is a narrower group.

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Does TRT Make an Enlarged Prostate Worse? What TRAVERSE Showed About BPH and Urinary Symptoms in Men Over 45

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Men's Health 10 min read Nov 2, 2026

Does TRT Make an Enlarged Prostate Worse? What TRAVERSE Showed About BPH and Urinary Symptoms in Men Over 45

The FDA label still warns that testosterone can worsen benign prostatic hyperplasia. The largest prostate safety trial, plus two meta-analyses, found urinary symptoms moved the same on testosterone as on placebo. Here is what the numbers show, who they apply to, and what to monitor.

The testosterone label warns about worsening BPH, yet in 5204 men in TRAVERSE, urinary symptom scores changed the same on testosterone gel as on placebo. What the trial measured, and where its limits are.

Does TRT make an enlarged prostate worse? In the best trial evidence, testosterone therapy did not worsen urinary symptoms in men with low testosterone. The TRAVERSE prostate safety study (Bhasin and colleagues, JAMA Network Open, 2023) followed 5204 men and found that urinary symptom scores changed the same on testosterone gel as on placebo, and acute urinary retention was rare in both groups: 0.77% versus 0.61%.

The FDA label for AndroGel 1.62% still warns that men with benign prostatic hyperplasia (BPH) who take androgens are at increased risk of worsening BPH symptoms. Both statements can be true. The trial screened out men with severe symptoms or a high PSA, and the label warning predates the trial. This article covers what TRAVERSE measured, what the meta-analyses add, and what a man with an enlarged prostate should track on testosterone.

0.77% vs 0.61%

Acute Urinary Retention

Testosterone gel vs placebo in TRAVERSE (Bhasin, JAMA Netw Open 2023)

0.89% vs 0.46%

Invasive Prostate Procedures

Higher on testosterone, but not statistically significant (P = .07)

3.89% vs 3.34%

Started a New Urinary Symptom Drug

No significant difference, TRAVERSE

14 trials

No IPSS Worsening in Meta-Analysis

2029 men, Kohn et al., European Urology 2016

IPSS over 19

Excluded From TRAVERSE

Men with severe symptoms were not studied

Does TRT Make an Enlarged Prostate Worse?

TRT does not make an enlarged prostate worse on average, based on randomized trials in men with low testosterone and mild to moderate urinary symptoms. In TRAVERSE, the International Prostate Symptom Score (IPSS) rose over time in both groups, and the change from baseline did not differ between testosterone and placebo. Acute urinary retention, prostate surgery for BPH, and starting a new drug for urinary symptoms were all uncommon and statistically similar between groups.

The worry about TRT and BPH comes from biology. Testosterone and its derivative dihydrotestosterone (DHT) drive prostate growth, which is why drugs that block DHT shrink the gland. The question trials answer is whether restoring testosterone to the normal range in men who are deficient adds enough growth to cause symptoms. For men in the studied range, the answer so far is no measurable difference in symptoms. Our guide to DHT, hair loss and finasteride on TRT covers the DHT side in more depth.

What Did the TRAVERSE Trial Find About the Prostate?

The TRAVERSE prostate analysis found low and similar rates of every prostate event it tracked. The trial enrolled 5246 men aged 45 to 80 from 316 US sites. Each had two testosterone readings below 300 ng/dL, symptoms of low testosterone, and heart disease or a high risk of it. Men applied 1.62% testosterone gel or a placebo gel. Mean treatment lasted 21.8 months on testosterone and 21.6 months on placebo, adding up to 14,304 person-years of follow-up.

A blinded committee adjudicated each prostate event against medical records. Acute urinary retention, defined as being unable to pass urine and needing an emergency visit or a catheter, occurred in 20 men on testosterone (0.77%) and 16 on placebo (0.61%), a hazard ratio of 1.25. New prescriptions for urinary symptoms went to 101 men on testosterone (3.89%) and 87 on placebo (3.34%). Prostate biopsies were 0.62% versus 0.54%.

Prostate Events in TRAVERSE, Testosterone vs Placebo (Source: Bhasin et al., JAMA Network Open, 2023)

One number deserves a closer look. Invasive prostate procedures for BPH occurred in 23 men on testosterone (0.89%) and 12 on placebo (0.46%), a hazard ratio of 1.91. The difference missed statistical significance (P = .07), and the authors note it was not significant. With so few events, a real but small increase cannot be ruled out, so it is fair to treat this as a signal worth watching rather than proof of safety.

Who TRAVERSE Did Not Study

TRAVERSE excluded men with a PSA above 3.0 ng/mL (above 1.5 ng/mL in men on a 5-alpha-reductase inhibitor such as finasteride), a prostate nodule, or an IPSS above 19, which is the severe range. Its results describe men with mild or moderate urinary symptoms and a low-risk prostate. They do not tell you how testosterone behaves in a man who already has severe BPH symptoms.

How Is Urinary Symptom Severity Measured?

Urinary symptom severity is measured with the International Prostate Symptom Score, a short questionnaire that scores how often you have problems such as weak stream, urgency and waking at night to urinate. According to the Kaiser Permanente Healthwise tool, a total of 0 to 7 is mild, 8 to 19 is moderate and 20 to 35 is severe. The average man in TRAVERSE started at an IPSS of 7.1, at the top of the mild band.

IPSS Severity Bands and Where TRAVERSE Fits (Source: Kaiser Permanente Healthwise; Bhasin 2023)

0 to 7

Mild symptoms

TRAVERSE men started here on average, at a mean IPSS of 7.1.

→

↓

8 to 19

Moderate symptoms

Included in TRAVERSE. Symptom change did not differ from placebo.

→

↓

20 to 35

Severe symptoms

Excluded from TRAVERSE. No large trial data on testosterone in this group.

During TRAVERSE, 378 of the 4809 men with a follow-up score (7.9%) crossed into the severe range above 19. That happened to 180 men on testosterone (7.5%) and 198 on placebo (8.2%). Urinary symptoms worsen with age whether or not a man takes testosterone, and in this trial slightly fewer men on testosterone reached the severe band. Waking at night to urinate is one of the most common of these symptoms; our guide to nocturia in men explains its other causes.

What Do the Meta-Analyses Say About Testosterone and Urinary Symptoms?

The meta-analyses agree with TRAVERSE: testosterone therapy does not worsen urinary symptoms in men with late-onset hypogonadism. Kohn and colleagues (European Urology, 2016) pooled 14 randomized trials with 2029 men, average age 64.5, followed for an average of 34.4 months. IPSS changed by -0.41 points on testosterone and 0.12 points on placebo, with no significant difference between groups. Seven trials used topical testosterone, five used injections and two used oral forms.

A 2024 network meta-analysis by Yuan and colleagues (Journal of Evidence-Based Medicine) compared delivery routes across 21 randomized trials and 2453 men. It found no significant IPSS, PSA or prostate volume difference between transdermal, intramuscular and oral testosterone. In subgroups, long-term intramuscular testosterone lowered IPSS, short-term transdermal testosterone raised PSA, and short-term intramuscular testosterone increased prostate volume. The authors concluded that testosterone does not worsen urinary symptoms regardless of route.

Key Studies on Testosterone Therapy and Urinary Symptoms

Study	Men studied	Urinary symptom finding
TRAVERSE prostate analysis, JAMA Netw Open 2023	5204 men aged 45 to 80, testosterone gel vs placebo	IPSS change did not differ; retention 0.77% vs 0.61%
Kohn et al., Eur Urol 2016	14 trials, 2029 men	IPSS -0.41 on testosterone vs 0.12 on placebo, no difference
Yuan et al., J Evid Based Med 2024	21 trials, 2453 men	No route worsened IPSS; long-term injections lowered it
Rastrelli et al., J Endocrinol Invest 2022	120 men awaiting BPH surgery	No difference in symptom improvement vs placebo (OR 0.96)

What Happens When Men Who Already Have BPH Take Testosterone?

In the one randomized trial done in men already waiting for BPH surgery, testosterone neither worsened nor improved urinary symptoms. Rastrelli and colleagues (Journal of Endocrinological Investigation, 2022) enrolled 120 men with metabolic syndrome who were on the waiting list for BPH surgery and gave them 2% testosterone gel (5 g daily) or placebo for 24 weeks. Urinary symptom improvement did not differ between groups, with an odds ratio of 0.96.

The Rastrelli trial also measured the gland directly. In testosterone-deficient men who received testosterone, total prostate volume rose by 2.64 mL, but the adenoma (the enlarged tissue that pinches the urethra) did not grow significantly. Ultrasound and tissue markers of prostate inflammation improved on testosterone. The study was small and short, so it supports, rather than settles, the view that restoring testosterone does not aggravate existing BPH.

Why Does the FDA Label Still Warn About BPH?

The FDA label warns about BPH because androgens can stimulate prostate growth, and that caution applies to every man the drug may reach, including those outside the trial populations. Section 5.1 of the AndroGel 1.62% label states that patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms, and tells prescribers to monitor them. The geriatric use section repeats that older men on androgens may be at risk of worsening BPH.

The label and the trials measure different things. The trials report averages in screened men with mild or moderate symptoms. The label covers anyone, including men with severe symptoms, very large glands or levels pushed above the normal range. A 2024 review by Bhasin and Thompson (Journal of Clinical Endocrinology and Metabolism) summarized the four large testosterone trials and concluded that testosterone did not worsen urinary symptoms in carefully screened men, while recommending a baseline prostate evaluation and a standard monitoring plan.

Does TRT Raise PSA, and Does That Mean the Prostate Is Growing?

TRT raises PSA slightly, mostly in the first year, and a small rise does not by itself mean the prostate is enlarging or that cancer is present. In TRAVERSE, PSA rose more on testosterone than on placebo by an estimated 0.11 ng/mL at 3 months and 0.15 ng/mL at 12 months. After month 12 the gap was no longer statistically significant, narrowing to 0.01 ng/mL at 36 months.

Extra PSA Rise on Testosterone vs Placebo in TRAVERSE, ng/mL (Source: Bhasin et al., JAMA Network Open, 2023)

Those PSA shifts did lead to more urology referrals. In TRAVERSE, 57 men on testosterone (2.2%) and 28 on placebo (1.1%) met the trial's criteria for urologic evaluation, such as a confirmed PSA above 4.0 ng/mL or a first-year rise of more than 1.4 ng/mL. Only 16 of the 85 referred men (18.8%) chose a biopsy. Our guide to PSA monitoring on TRT explains how to read these changes without overreacting.

How Should Men With an Enlarged Prostate Be Monitored on TRT?

Men with an enlarged prostate on TRT should have their urinary symptoms and PSA checked at the start, early in treatment and then at regular intervals. TRAVERSE used a prespecified plan: PSA at baseline, 3 months, 12 months and every year after; IPSS at baseline, 3 months, 12 months, 36 months and the end of the study; and digital rectal exams at baseline, 12 months and 36 months. No trial has compared monitoring schedules, so treat the plan below as the schedule TRAVERSE used, not a proven protocol.

A Prostate Monitoring Plan Modeled on TRAVERSE

Before starting

✓Fill in an IPSS questionnaire and note your score band
✓Get a baseline PSA and a prostate exam
✓Tell your prescriber about any past urinary retention or BPH medication

Month 3

✓Repeat PSA
✓Repeat the IPSS and compare it with your baseline

Month 12

✓Repeat PSA, IPSS and a prostate exam
✓Discuss any confirmed PSA rise of more than 1.4 ng/mL with a urologist

Every year after

✓Annual PSA
✓Recheck the IPSS if symptoms change
✓Seek care quickly if you cannot pass urine

Some warning signs need prompt attention whatever the monitoring schedule says. Being unable to urinate at all is a medical emergency. A clear jump in your IPSS, a much weaker stream or new difficulty starting to urinate is worth reporting before the next scheduled visit. This article is for educational purposes only and is not medical advice. It does not diagnose, treat, cure or prevent any disease, and decisions about testosterone therapy belong with a qualified clinician.

Bhasin S, Travison TG, Pencina KM, et al. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Network Open, 2023. https://doi.org/10.1001/jamanetworkopen.2023.48692
Kohn TP, Mata DA, Ramasamy R, Lipshultz LI. Effects of Testosterone Replacement Therapy on Lower Urinary Tract Symptoms: A Systematic Review and Meta-analysis. European Urology, 2016. https://doi.org/10.1016/j.eururo.2016.01.043
Yuan X, Xiong X, Xue J. Effect of testosterone replacement therapy on lower urinary tract symptoms: A systematic review and network meta-analysis. Journal of Evidence-Based Medicine, 2024. https://doi.org/10.1111/jebm.12628
Rastrelli G, Cipriani S, Lotti F, et al. Testosterone does not affect lower urinary tract symptoms while improving markers of prostatitis in men with benign prostatic hyperplasia: a randomized clinical trial. Journal of Endocrinological Investigation, 2022. https://doi.org/10.1007/s40618-022-01776-9
Bhasin S, Thompson IM. Prostate Risk and Monitoring During Testosterone Replacement Therapy. Journal of Clinical Endocrinology and Metabolism, 2024. https://doi.org/10.1210/clinem/dgae334
US Food and Drug Administration. AndroGel 1.62% (testosterone gel) prescribing information, NDA 022309. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000Lbl.pdf
Kaiser Permanente Healthwise. Interactive Tool: How Bad Are Your Urinary Symptoms From Benign Prostatic Hyperplasia (BPH)? https://healthy.kaiserpermanente.org/health-wellness/health-encyclopedia/he.tf6834