RESUMO
STUDY DESIGN: Cohort study OBJECTIVES: The purpose of this study was to evaluate the performance of a re-engineered device (Ferticare 2.0), which is replacing the previous standard (Ferticare 1.0) for penile vibratory stimulation in men with spinal cord injury. Most men with spinal cord injury are anejaculatory, requiring medical assistance to obtain their semen. Penile vibratory stimulation is generally recognized as the standard of care for semen retrieval in these anejaculatory men. SETTING: Major Research University in Miami, Florida, USA. METHODS: The Ferticare 2.0 device was applied to 15 men with spinal cord injury in a three-step protocol simulating normal use. Step 1: one device (2.5 mm amplitude, 100 Hz) was applied to the glans penis for 2 min. Step 2: If no ejaculation occurred, the amplitude was increased to 4.0 mm (100 Hz) and the device similarly applied. Step 3: If no ejaculation occurred, two devices, each 2.5 mm and 100 Hz were applied to the dorsum and frenulum of the glans penis. Participants at risk for autonomic dysreflexia were pretreated with sublingual nifedipine (20 mg), 15 min prior to stimulation. Blood pressure and other symptoms of autonomic dysreflexia were monitored. Participants answered a questionnaire about their experience with the device. RESULTS: Thirteen of 15 participants ejaculated with the device. No adverse events occurred. All participants commented they would recommend the device to other men with spinal cord injury. CONCLUSIONS: A re-engineered device, the Ferticare 2.0, is safe and effective for inducing ejaculation in men with spinal cord injury.