Can tadalafil (Cialis) be used to manage nocturia in male patients with benign prostatic hyperplasia (BPH)?

Can Tadalafil Be Used to Manage Nocturia?

Yes, tadalafil 5 mg once daily is an effective FDA-approved treatment option for nocturia in men with benign prostatic hyperplasia (BPH), though the improvement is modest and works best when nocturia is part of broader lower urinary tract symptoms rather than isolated nighttime voiding. 1

FDA-Approved Indication and Mechanism

• Tadalafil 5 mg once daily is FDA-approved for treating signs and symptoms of BPH, which includes nocturia as a storage symptom 1
• The medication can simultaneously treat both erectile dysfunction and BPH symptoms when both conditions coexist 2, 1
• Tadalafil works by relaxing smooth muscle in the prostate and bladder, improving urinary flow and reducing storage symptoms 2

Evidence for Nocturia Improvement

• The American Urological Association recommends tadalafil 5 mg daily as a treatment option for patients with LUTS/BPH, with moderate recommendation strength and Grade B evidence 2
• In pooled data from four registrational trials (N=1,500), tadalafil 5 mg reduced nocturia frequency by -0.5 episodes versus -0.4 with placebo, achieving statistical significance (p=0.002) but representing a small treatment difference of only -0.2 episodes 3
• A prospective multicenter study (N=31) demonstrated that tadalafil significantly improved nocturia after 4 weeks, with sustained improvements through 12 weeks, and significantly increased hours of undisturbed sleep 4
• The same study showed significant improvements in nocturia-related quality of life, including inadequate sleep at night and overall bother 4

Clinical Efficacy Timeline

• Improvement in overall LUTS (International Prostate Symptom Score) appears as early as 1 week and achieves statistical significance by week 4 5, 6
• Approximately 69% of men achieve clinically meaningful improvement (≥3-point IPSS reduction), with 60% of responders showing improvement by week 1 and 79% by week 4 6
• Mean IPSS reduction with tadalafil 5 mg is -5.4 to -5.6 points compared to -3.6 points with placebo 2, 5

Critical Evaluation Before Prescribing

Before attributing nocturia solely to BPH, you must use a frequency-volume chart to exclude nocturnal polyuria, which requires different management 7:

• Nocturnal polyuria (nighttime urine production >33% of 24-hour output) requires fluid restriction and potentially desmopressin, not tadalafil 7
• Global polyuria (24-hour output >3 liters) requires lifestyle modification and addressing underlying causes 7
• Only bladder storage dysfunction from BPH will respond meaningfully to tadalafil 7

Absolute Contraindications and Safety Screening

Never prescribe tadalafil if the patient takes nitrates in any form—this combination can cause fatal hypotension 2, 1:

• Explicitly ask about nitroglycerin (tablets, sprays, patches, ointments), isosorbide dinitrate, isosorbide mononitrate 1
• Ask about recreational "poppers" (amyl nitrite, butyl nitrite) 1
• Tadalafil is also contraindicated with guanylate cyclase stimulators like riociguat 1

Assess cardiovascular fitness before prescribing 8:

• Ask if the patient can walk 1 mile in 20 minutes or climb 2 flights of stairs without symptoms 8
• Refer to cardiology if unable to perform moderate physical activity or if cardiovascular risk is indeterminate 8
• High-risk patients (unstable angina, uncontrolled hypertension, recent MI, NYHA Class II-IV heart failure) should defer treatment 8

Dosing and Administration

• The only recommended dose for BPH/nocturia is tadalafil 5 mg once daily—higher doses do not provide additional benefit for urinary symptoms 2, 1
• Take at approximately the same time each day, with or without food 1
• Tadalafil remains in the body for more than 2 days, which is important for emergency nitrate administration timing 1

Important Clinical Pitfall: Combination Therapy

Do not combine tadalafil 5 mg with alpha-blockers (tamsulosin, alfuzosin, doxazosin) for LUTS/BPH—this offers no additional symptom benefit over either agent alone and significantly increases side effects, particularly hypotension 2, 9:

• The American Urological Association explicitly recommends against this combination 2, 9
• If a patient is already on an alpha-blocker with adequate symptom control, consider switching to tadalafil only if erectile dysfunction is also present 2

Common Adverse Effects

• Most common side effects include headache (3.7%), back pain (3.1%), dyspepsia, nasal congestion, and myalgia 1, 5
• Adverse event rates are generally low and consistent with tadalafil's use for erectile dysfunction 5
• No serious adverse events were observed in the nocturia-specific study 4

When Tadalafil May Not Be the Best Choice

• If nocturia is the predominant or isolated symptom, first complete a frequency-volume chart to exclude nocturnal polyuria before prescribing tadalafil 7
• If the patient has acute urinary retention, alpha-blockers (tamsulosin, alfuzosin) are first-line, not tadalafil 9
• If voiding symptoms predominate over storage symptoms, alpha-blockers or 5-alpha reductase inhibitors may be more appropriate 7
• The 2023 European Association of Urology guidelines note that while tadalafil improves LUTS, the specific impact on nocturia requires further study with voiding diaries 7

Realistic Expectations

• The improvement in nocturia frequency is statistically significant but modest (approximately 0.2 fewer episodes per night compared to placebo) 3
• The clinical meaningfulness is debated—individual studies did not show significant nocturia improvements, only pooled data did 3
• Tadalafil appears most effective when nocturia is part of broader LUTS rather than an isolated symptom 4, 3
• Quality of life improvements related to nocturia (sleep quality, overall bother) may be more clinically relevant than the absolute reduction in voiding frequency 4