Diagnostic Performance of a Flexible Penile Monitoring System for ED

This study aims to evaluate the diagnostic performance of a novel intelligent flexible penile monitoring system for erectile dysfunction (ED). The current gold standard, RigiScan Plus, often causes discomfort and disrupts sleep due to its mechanical rings, leading to potential "first-night effect" biases. This research utilizes a prospective crossover design to compare the accuracy of the new flexible system with RigiScan in measuring peak rigidity and tumescence. A total of 60 participants (30 ED patients and 30 healthy volunteers) will be enrolled. The study expects to confirm that the flexible system provides highly accurate diagnostic data while significantly improving patient comfort and maintaining natural sleep structures.

Inclusion Criteria: 1. Males aged 18-70 years with good communication and compliance. 2. Able to follow clinical Standard Operating Procedures (SOPs) and complete two-stage nocturnal monitoring and clinic-induced tests. 3. Fully informed about the study and signed the informed consent form. 4. For ED Group: Clinically diagnosed with erectile dysfunction with an IIEF-5 score \< 21. 5. For Healthy Group: Normal erectile function, no history of related physiological diseases or sexual psychological disorders, with an IIEF-5 score ≥ 21. Exclusion Criteria: 1. Systemic diseases: Severe cardiovascular disease (e.g., recent myocardial infarction, unstable angina), uncontrolled severe diabetes, or severe obstructive sleep apnea syndrome. 2. Local anatomical factors: Severe penile malformation, spinal cord injury, or organic structural damage caused by pelvic fracture; or major surgery within the last six months. 3. Skin and allergy factors: Active infection or eczema in the penile area, or known allergy to flexible materials (medical-grade silicone/adhesives). 4. Mental and psychological factors: Untreated or unstable severe depression, anxiety, or other mental disorders. 5. Medication interference: Current use of PDE5 inhibitors, androgens, anti-androgens, or drugs that significantly interfere with REM sleep structure. 6. Other factors: Currently participating in other interventional clinical trials, or judged by researchers to have poor compliance.