[Favorable effect of sildenafil on erectile dysfunction in patients after radiotherapy for prostate cancer; randomised, double-blind, placebo-controlled crossover study].

Abstract

OBJECTIVE:

To determine the efficacy of sildenafil in patients with erectile dysfunction after external beam radiotherapy for prostate cancer.

DESIGN:

Randomised, double-blind, placebo-controlled, crossover study.

METHOD:

A total of 406 patients with erectile dysfunction reported in their medical records who had completed external beam radiotherapy at least 6 months prior to the study, were approached by letter. Sixty patients were included in a study which lasted 12 weeks. They received 50 mg of sildenafil citrate or placebo for two weeks; during week 2 the dose could be increased to 100 mg in the case of unsatisfactory erectile response. At week 6 patients crossed over to the alternative treatment. Data were collected using the validated 'International index of erectile function' (IIEF) questionnaire, and side-effects were recorded. Patients were given the possibility of continuing to a 6-week open-label phase.

RESULTS:

The mean age of those participating was 68 years. All patients completed the double-blind phase. For the majority f questions in the IIEF questionnaire, there was a significant increase in mean scores from baseline with sildenafil, but of the patients with sildenafil, versus 18% with placebo. Ninety percent of the patients required a dose adjustment to 100 mg sildenafil, and 100% of the patients in the placebo group increased the dose. Side-effects were mild or moderate. Patients who proceeded to the open-label phase reported the same results as in the double-blind phase.

CONCLUSION:

Sildenafil improved erectile function in about half of the patients with erectile dysfunction after external beam radiotherapy for prostate cancer, and it was well tolerated.

• Authors: L Incrocci, W C J Hop, A K Slob
• Journal: Nederlands tijdschrift voor geneeskunde (Ned Tijdschr Geneeskd) Vol. 147 Issue 35 Pg. 1687-90 (Aug 30 2003) ISSN: 0028-2162 [Print] Netherlands
• Vernacular Title: Gunstig effect van sildenafil op erectiele disfunctie bij patiënten na radiotherapie voor prostaatkanker; gerandomiseerd, dubbelblind, placebogecontroleerd en gekruist onderzoek.
• PMID: 14569951 (Publication Type: Clinical Trial, English Abstract, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Piperazines
• Purines
• Sulfones
• Vasodilator Agents
• Sildenafil Citrate

Topics

• Aged
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Erectile Dysfunction (drug therapy, etiology)
• Humans
• Male
• Middle Aged
• Piperazines (administration & dosage, therapeutic use)
• Prostatic Neoplasms (complications, radiotherapy)
• Purines
• Radiation Injuries (drug therapy, etiology)
• Sildenafil Citrate
• Sulfones
• Surveys and Questionnaires
• Vasodilator Agents (administration & dosage, therapeutic use)