Acupuncture for erectile dysfunction in post-stroke patients: Study Protocol Clinical Trial (SPIRIT Compliant).

INTRODUCTION

Erectile dysfunction refers to the continued inability of the penis to reach and maintain sufficient erections to achieve a satisfactory sex life and last at least 6 months. As part of traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate, the exact effect of acupuncture on the clinical efficacy of patients with Post-stroke Erectile dysfunction (PSED), this experiment uses randomized controlled experiments.

METHODS/

DESIGN

This pragmatic randomized controlled trial will recruit 103 patients who are diagnosed with PSED. Simple randomization to conventional treatment with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional treatment. The selection of outcomes will be evaluated by International Erectile Function Index-5 (IIEF-5) score at week 8.

DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with PSED.

TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000030231, Registered on February 25, 2020.