(455 days)
The Seager Model Electroejaculator (EE) is intended to induce seminal emission in patients for whom prior or present illness precludes their ability to spontaneously ejaculate. The EE device is indicated for use in neurologically impaired males who are 18 yrs. and anejaculatory due to the following conditions:
Spinal Cord Injury (paralysis)
Retroperitoneal Lymph Node Dissection (RPLND) [surgical therapy post testicular cancer]
Idiopathic (neuropsychosis/psychogenic)
Diabetes
Spina Bifida
Pelvic Surgery Complications
Multiple Sclerosis (MS)
Neurological Impairments
The EE device is contraindicated in the following individuals:
Chron's Disease
Ulcerative Colitis
Rectal cancer or other significant rectal pathology
Patients with pacemakers or other artificial heart device
The Seager EE device consists of a power unit and rectal probe which is designed to provide low level (5-10 volts) electrical stimulation. The rectal probes vary in diameter from 1 inch to 1 5/16 inches. Prior to the procedure, a rectal exam is performed to determine the correct probe size and assure that the rectal mucosa are not compromised. For spinal cord injured patients with lesions at T-6 or above, or patients at risk of dysreflexia (elevated blood pressure), this may be controlled with appropriate medication (e.g. Procardia; nitrogylcerine). For non spinal cord injured patients whose lesion may be Incomplete, short general anesthesia (GA) may be administered.
The rectal probe is inserted into the rectum and a series of low level electrical stimulations are delivered to the prostate gland and seminal vesicles. Once the patient begins to ejaculate (usually after 5 to 10 stimulations), additional stimulations (10 to 12) are applied to obtain the entire ejaculate volume. During the procedure, patient comfort and blood pressure are monitored. If blood pressure increases above 180 systolic and/or 120 diastolic, the procedure is halted until pressures return to normal and the patient wishes to continue. After discontinuation of rectal stimulation, blood pressure is monitored until it returns to normal physiological levels. Following the procedure, the rectal mucosa is re-examined to assess any changes from pre-stimulation.
The rectal probe, which comes into short-term (3-5 minutes) contact with the rectal mucosa, is manufactured from medical grade (306) stainless steel electrodes embedded in a polyvinylchloride (grade 6 PVC) substrate.
Acceptance Criteria and Study for Seager Electroejaculator
This document outlines the acceptance criteria for the Seager Electroejaculator (EE) and details the clinical study performed to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Safety | Minimal risk of dysreflexia (elevated blood pressure) | Average blood pressures during the EE procedure remained well within normal physiological range. Slightly elevated systolic blood pressures (3 - 7 mm Hg, p |
N/A