Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months.
No cause of the disease has been established, and therapies are empirical and mostly untested.
Antimicrobial agents and -adrenergic receptor blockers are frequently used.
Objective: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS.
Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo.
Urology outpatient clinics at 10 tertiary care medical centers in North America.
Patients were identified from referral-based practices of urologists. 196 men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled.
| No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin|
|Annals of Internal Medicine|
Patients had received substantial previous treatment.
The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events.
Interventions: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo.
Results: The NIH-CPSI total score decreased modestly in all treatment groups.
No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2).
Treatments also did not differ significantly for any of the secondary outcomes.
Treatment lasting longer than 6 weeks was not tested.
Patients who had received less pretreatment may have responded differently.
Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.