Elsevier

Urology

Volume 62, Issue 3, September 2003, Pages 425-429
Urology

Adult urology: CME article
Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized, double-blind, placebo-controlled, pilot study

https://doi.org/10.1016/S0090-4295(03)00466-7Get rights and content

Abstract

Objectives

To perform a prospective, placebo-controlled study to examine the long-term efficacy of alfuzosin compared with placebo and standard therapy in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), because alpha-blockers have been suggested for the treatment of CP/CPPS.

Methods

One hundred twenty consecutive men diagnosed with CP/CPPS were prospectively screened and then asked to participate in a prostatitis treatment trial. Patients who agreed to be randomized were subsequently randomized to alfuzosin 5 mg twice daily or placebo and patients who agreed to participate but not be randomized were entered into a control or standard (except alpha-blockers) therapy group. Patients were prospectively treated for 6 months and then followed up for an additional 6 months. The change from baseline in the total and domain scores of the validated Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was the primary outcome parameter for this study.

Results

Seventy subjects agreed to participate in the study. The data from 66 patients were available for evaluation (17 in the alfuzosin, 20 in the placebo, and 29 in the control/standard group). At the end of 6 months of active therapy, the alfuzosin group had had a statistically significant decrease in total NIH-CPSI score compared with the placebo and control/standard groups (9.9, 3.8, and 4.3 decrease, respectively, P = 0.01). A statistically significant improvement occurred in the pain score in the alfuzosin group at 6 months compared with the placebo and control/standard groups (P = 0.01), but not in the voiding or quality-of-life score among the three groups. Of the patients in the alfuzosin group, 65% had a greater than 33% improvement in the mean NIH-CPSI total score compared with 24% and 32% of the placebo and control/standard groups, respectively (P = 0.02). At 12 months (6 months after the alfuzosin/placebo treatment was discontinued), the symptom scores in all domains of the NIH-CPSI showed deterioration compared with original baseline score in the alfuzosin and placebo groups but not in the control/standard group (NIH-CPSI score 3.5, 0.1, and 5.6 points below baseline, respectively). Gastrointestinal symptoms and a decrease in ejaculate volume were noted by 1 and 4 patients, respectively, in the alfuzosin group. No patients dropped out of the study because of an adverse event.

Conclusions

Six months of alfuzosin therapy for CP/CPPS is safe and well tolerated and results in a modest, but statistically significant, improvement in the NIH-CPSI, particularly in the pain domain, compared with placebo and standard/traditional treatment. The beneficial effect is only apparent after several months of treatment and disappears when treatment is discontinued.

Section snippets

Material and methods

The study used a randomized, double-blind, placebo-controlled design with a third positive control group (standard therapy group). It was conducted at two hospitals (Oulu University Hospital and the District Hospital of Oulainen). The trial consisted of a 6-month active treatment period followed by a 6-month survey. One hundred twenty consecutive male patients, aged 20 to 70 years, clinically diagnosed with CP/CPPS (categories IIIA and IIIB) were screened and then asked to participate in a

Results

Seventy men agreed to participate in the study. Of these, 40 agreed to be randomized (19 alfuzosin and 21 placebo) and 30 agreed to participate without randomization (positive control standard/therapy group). Data from 66 patients were available for evaluation at 6 months (17 in alfuzosin, 20 in placebo, and 29 in control/standard group) and from 61 patients at 12 months (16 in alfuzosin, 19 in placebo, and 26 in control/standard group). Four patients dropped out of the study before the 6-month

Comment

The results of this study showed that it is possible to reduce CP/CPPS-related symptoms as measured by the NIH-CPSI with 6 months of alfuzosin alpha-blocker therapy. The nonselective alpha-blocker, phenoxybenzamine, was first shown by Osborn et al.8 in 1981 to be effective in the treatment of symptoms of patients with prostatodynia. Later studies with more selective alpha-1 blockers (alfuzosin, terazosin, and doxazosin) have also shown a degree of symptom amelioration with this therapy.6, 7, 9

Conclusions

Alfuzosin was shown in this pilot study to produce a modest improvement in symptoms, primarily pain, as measured by the NIH-CPSI. Alpha-blocker therapy, specifically alfuzosin therapy, for CP/CPPS is well tolerated and produces modest symptom amelioration. However, it is recommended that therapy be prolonged and also not be considered for monotherapy for patients with CP/CPPS16.

Acknowledgements

To Leiras OY Finland for supplying the medication for patients at no cost and to the pharmacy of Helsinki University for making the placebo tablets for this clinical trial.

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    The phenotype system is UPOINT, including Urinary symptoms, Psychosocial dysfunction, Organ specific findings, Infection, Neurologic/systemic and Tenderness of muscle. For urinary symptoms, alpha blocker7,9,12,42,50 and antimuscarinics are suggested when treating CP/CPPS. When targeting psychosocial dysfunction, counseling, cognitive behavioral therapy,23 antidepressants, and anxiolytics are potential treatment modalities.

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A research award from the Prostatitis Foundation was helpful in assisting with data analysis. J. C. Nickel's prostatitis research unit is funded in part by the NIH-NIDDK (R01 DK5374601).

J. C. Nickel is a paid consultant to, and study investigator funded by, Sanofi-Synthelabo, Canada (Benign Prostatic Hyperplasia).

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