What is the recommended treatment for erectile dysfunction (ED) and Benign Prostatic Hyperplasia (BPH) using Cialis (tadalafil)?

Tadalafil for Erectile Dysfunction and Benign Prostatic Hyperplasia

For men with both erectile dysfunction and BPH symptoms, tadalafil 5 mg once daily is the recommended first-line treatment as it effectively treats both conditions simultaneously with a single medication. 1, 2, 3

Treatment Approach for Combined ED and BPH

First-Line Monotherapy

• Start with tadalafil 5 mg once daily for men presenting with both ED and moderate-to-severe lower urinary tract symptoms (IPSS ≥13). 4, 5, 2
• This dosing provides significant improvement in both conditions: mean IPSS reduction of -5.4 to -6.1 points (vs. -3.6 to -3.8 with placebo) and IIEF-EF domain improvement of 6.5 points (vs. 1.9 with placebo). 3, 6
• Symptom improvement begins as early as 2 weeks and is maintained through 12 weeks and beyond. 3, 6

Critical Contraindications to Screen For

• Absolute contraindications include: concurrent nitrate use (nitroglycerin, isosorbide), guanylate cyclase stimulators (riociguat), recent stroke or MI, and uncontrolled hypertension or hypotension. 3, 2
• The active ingredient remains in the body for more than 2 days after a single dose, making nitrate use dangerous even days after tadalafil administration. 3

What NOT to Do: Combination Therapy Pitfall

Do not combine tadalafil 5 mg with alpha-blockers (tamsulosin, alfuzosin, etc.) for LUTS/BPH treatment. 1, 4, 5

• The 2021 AUA guideline explicitly states this combination offers no advantages in symptom improvement over either agent alone and increases side effect risk. 1
• This is a Grade C moderate recommendation that should guide clinical practice. 1
• If LUTS control is inadequate after 4-12 weeks of tadalafil monotherapy, consider adding an alpha-blocker only after careful risk-benefit discussion, though evidence does not support additional benefit. 2

Alternative Sequential Approach

If you prefer to prioritize rapid LUTS improvement over treating both conditions simultaneously:

• Start with an alpha-blocker alone (tamsulosin, alfuzosin, or silodosin) for faster LUTS relief (2-4 weeks). 2
• Then treat ED separately with on-demand PDE5 inhibitors (sildenafil, vardenafil, or avanafil) rather than daily tadalafil. 2
• However, this approach requires two medications and alpha-blockers cause ejaculatory dysfunction in many men, whereas tadalafil actually improves ejaculatory function. 7

When to Add 5-Alpha Reductase Inhibitors

Add finasteride 5 mg or dutasteride 0.5 mg daily only if the prostate is enlarged: prostate volume >30cc, PSA >1.5 ng/mL, or palpable enlargement on digital rectal exam. 2

• 5-ARIs reduce prostate size by 15-25% over 6 months and prevent disease progression but are ineffective in men with normal-sized prostates. 2
• If initiating tadalafil with finasteride together, this combination is recommended for up to 26 weeks only, as the incremental benefit of tadalafil decreases from week 4 to week 26, and benefit beyond 26 weeks is unknown. 3
• Always double the PSA value when monitoring for prostate cancer in men taking 5-ARIs, as these medications reduce PSA by approximately 50%. 2

Dosing and Administration Details

• The only FDA-approved dose for BPH is tadalafil 5 mg once daily. 5, 3
• Tadalafil 2.5 mg once daily did not achieve statistical significance for IPSS improvement and should not be used for BPH treatment. 6
• Sexual activity timing is not restricted relative to when patients take tadalafil, unlike on-demand PDE5 inhibitors. 3
• Some form of sexual stimulation is required for tadalafil to produce an erection. 3

Expected Outcomes and Follow-Up

• Evaluate treatment response at 4-12 weeks using IPSS questionnaire and erectile function assessment. 2
• Improvements in urinary symptoms occur regardless of age, previous alpha-blocker treatment, baseline LUTS severity, or ED status. 8
• Tadalafil also significantly improves ejaculatory function, orgasmic frequency, intercourse satisfaction, and overall sexual satisfaction compared to placebo. 7
• In contrast, tamsulosin significantly decreases ejaculatory/orgasmic frequency and overall satisfaction compared to placebo. 7

Common Side Effects

• Most common adverse effects include headache, flushing, dyspepsia, back pain, nasal congestion, and myalgia. 1, 5
• Tadalafil has the lowest rates of flushing among PDE5 inhibitors. 1
• Overall, tadalafil is well tolerated with discontinuation rates due to adverse events of approximately 1.79 times placebo. 9

Special Populations and Monitoring

• Use tadalafil with caution at lower initial doses in men with mild-to-moderate hepatic or renal impairment due to delayed metabolism. 1
• Tadalafil is generally not recommended in men with severe renal or liver disease. 1
• Perform cardiovascular risk assessment before prescribing, as ED is a strong predictor of future cardiac events. 1, 5
• Warn patients planning cataract surgery about alpha-blocker use (if added later) due to intraoperative floppy iris syndrome risk. 2

Key Clinical Pearls

• Tadalafil does not cure ED, increase sexual desire, protect against sexually transmitted diseases, or serve as birth control. 3
• Tadalafil is only for men over age 18. 3
• Maximum urinary flow rate (Qmax) increases with tadalafil were not significantly different from placebo, suggesting the mechanism is not primarily through bladder outlet obstruction relief. 3
• Do not assume alpha-blockers used for LUTS adequately control hypertension—separate antihypertensive management may be required. 2