How does Cialis (tadalafil) treat Benign Prostatic Hyperplasia (BPH)?

From the Guidelines

Cialis (tadalafil) is a viable treatment option for Benign Prostatic Hyperplasia (BPH), with a mean difference in International Prostate Symptom Score (IPSS) of -2.09, as shown in a 2021 study published in The Journal of Urology 1. The mechanism of action of tadalafil in treating BPH involves relaxing smooth muscle in the prostate and bladder neck, which helps improve urinary symptoms.

• The typical dosage for BPH treatment is 5 mg taken once daily at approximately the same time each day, regardless of timing of sexual activity.
• Tadalafil works by inhibiting phosphodiesterase type 5 (PDE5), which increases cyclic guanosine monophosphate (cGMP) levels in smooth muscle cells.
• This leads to muscle relaxation in the lower urinary tract, reducing urinary obstruction and improving symptoms like weak stream, hesitancy, incomplete emptying, and frequent urination. According to the study, tadalafil has been shown to be effective in improving IPSS, with a ranking of 8.15 out of 13 treatments listed 1.
• Patients typically notice improvement in symptoms within 1-2 weeks, though full effects may take up to 4 weeks.
• Tadalafil can be taken with or without food, and patients should continue taking it daily for ongoing symptom relief. Common side effects include headache, indigestion, back pain, muscle aches, flushing, and nasal congestion, which are usually mild and temporary.
• Patients should inform their doctor about all medications they take, as tadalafil can interact with nitrates, alpha-blockers, and certain other drugs. It is essential to note that the effectiveness of tadalafil in treating BPH may vary depending on individual patient factors, such as prostate size and PSA levels, as discussed in the 2021 guideline on the management of lower urinary tract symptoms attributed to BPH 1.

From the FDA Drug Label

Tadalafil tablets for the Treatment of Symptoms of BPH BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms Tadalafil tablets helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity In each of these 2 trials, tadalafil 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo

Tadalafil treats BPH by improving the symptoms of the condition, as measured by the International Prostate Symptom Score (IPSS). The medication has been shown to result in statistically significant improvement in the total IPSS compared to placebo in clinical trials 2. Key benefits of tadalafil for BPH treatment include:

• Improvement in urinary symptoms
• Increase in blood flow
• Reduction in severity of irritative and obstructive symptoms It is essential to note that tadalafil does not cure BPH, but rather helps to manage the symptoms of the condition 2.

From the Research

Mechanism of Action

• Tadalafil, the active ingredient in Cialis, is a phosphodiesterase type 5 (PDE5) inhibitor that treats Benign Prostatic Hyperplasia (BPH) by relaxing the smooth muscles in the prostate and bladder neck, improving urine flow and reducing symptoms of BPH 3.

Efficacy in Treating BPH

• Studies have shown that tadalafil significantly improves lower urinary tract symptoms (LUTS) associated with BPH, including improvements in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) 4, 5, 3.
• Tadalafil has been shown to improve IPSS voiding subscores, indicating a reduction in symptoms such as weak stream, straining, and intermittent flow 5.
• The improvement in LUTS with tadalafil is thought to be due to its ability to relax the smooth muscles in the prostate and bladder neck, reducing the obstruction to urine flow and improving bladder emptying 3.

Effects on Nocturia

• Nocturia, or nighttime voiding, is a common symptom of BPH, and tadalafil has been shown to improve nocturia in some studies 4.
• However, the improvement in nocturia with tadalafil is generally small and may not be considered clinically meaningful in all cases 4.

Time to Onset of Improvement

• Studies have shown that tadalafil can provide rapid improvement in LUTS, with some patients experiencing clinically meaningful improvement within 1-4 weeks of starting treatment 6.
• The exact mechanism by which tadalafil improves LUTS is not fully understood, but it is thought to involve the relaxation of smooth muscles in the prostate and bladder neck, as well as other effects on the lower urinary tract 3.