The FDA ( Food and Drug Administration ) has approved Cialis ( Tadalafil ) to treat the signs and symptoms of benign prostatic hyperplasia ( BPH ), a condition in which the prostate gland becomes enlarged, and for the treatment of benign prostatic hyperplasia and erectile dysfunction ( ED ), when the conditions occur simultaneously.

Cialis was approved in 2003 for the treatment of erectile dysfunction.

Common symptoms of benign prostatic hyperplasia include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.
The severity of symptoms of benign prostatic hyperplasia can be measured using the International Prostate Symptom Score ( IPSS ).

In two clinical trials, men with benign prostatic hyperplasia who took 5 mg of Tadalafil once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.
In a third study, men who experienced both erectile dysfunction and benign prostatic hyperplasia and who took 5 mg of Cialis once daily had improvement in both their symptoms of benign prostatic hyperplasia and in their erectile dysfunction compared to men who were treated with placebo.
The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

Tadalafil should not be used in patients taking nitrates, for example Nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Tadalafil in combination with alpha blockers for the treatment of benign prostatic hyperplasia is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of benign prostatic hyperplasia: Proscar, ( Finasteride ), Avodart ( Dutasteride ), Jalyn ( Dutasteride plus Tamsulosin ), and the alpha blockers: Hytrin ( Terazosin ), Cardura ( Doxazosin ), Flomax ( Tamsulosin ), Uroxatral ( Alfuzosin ) and Rapaflo ( Silodosin ).

Source: FDA, 2011

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