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Diagnostic Performance of a Flexible Penile Monitoring System for ED
Sponsor: Bin Xu
Summary
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.
Official title: Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction
Key Details
Gender
MALE
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-08-01
Completion Date
2028-02-01
Last Updated
2026-08-13
Healthy Volunteers
Yes
Conditions
Interventions
Intelligent Flexible Penile Monitoring System
A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
RigiScan Plus
Locations (1)
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China