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.
Nocturnal Penile Tumescence (NPT) monitoring is essential for differentiating psychogenic from organic ED. However, traditional mechanical devices pose physical loads that may trigger arousals during REM sleep. This study introduces a flexible sensing technology with an ultra-thin (\<0.8mm) layer to achieve "unfelt" monitoring. The primary objective is to assess the consistency of physical parameters (peak rigidity % and tumescence) between the flexible system and RigiScan Plus. Participants will be randomized 1:1 into two sequences for a two-night crossover monitoring process with a 3-7 day washout period. Secondary objectives include evaluating clinical diagnosis agreement (Kappa), sleep quality metrics (Arousal frequency), and patient comfort scores (VAS). Additionally, the study will explore the correlation between "deformation heatmaps" and hemodynamic indicators from Penile Color Doppler Ultrasound (CDDU) to improve fine-grained ED subtyping.
Study Type
OBSERVATIONAL
Enrollment
60
A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Measurement Accuracy of Peak Rigidity
Mean bias and 95% limits of agreement for peak rigidity (%) between the novel flexible system and RigiScan Plus.
Time frame: Day 1 and Day 8
Measurement Accuracy of Maximum Girth Expansion
Mean bias and 95% limits of agreement for maximum girth expansion (cm) between the novel flexible system and RigiScan Plus.
Time frame: Day 1 and Day 8
Clinical Diagnosis Agreement Rate
The degree of agreement in diagnostic conclusions (normal, psychogenic, or organic ED) between the two systems, evaluated using Cohen's Kappa coefficient.
Time frame: Day 1 and Day 8
Sleep Efficiency
Sleep efficiency, defined as the percentage of total sleep time spent asleep out of the total time spent in bed (%), collected by a medical-grade sleep recorder.
Time frame: Day 1 and Day 8
REM Sleep Percentage
Percentage of total sleep time spent in the Rapid Eye Movement (REM) sleep stage (%), measured by a medical-grade sleep recorder.
Time frame: Day 1 and Day 8
Unintended Arousal Frequency
Frequency of unintended arousals (number of events per hour) during sleep, measured by a medical-grade sleep recorder.
Time frame: Day 1 and Day 8
Subjective Sleep Perception Score (PSQI)
Participant subjective sleep perception evaluated using the Pittsburgh Sleep Quality Index (PSQI). The score ranges from 0 to 21, where higher scores indicate worse sleep quality.
Time frame: Day 2 and Day 8
Subjective Wearing Comfort Score
Participant subjective wearing comfort evaluated using the Visual Analogue Scale (VAS). The scale ranges from 0 (extreme discomfort) to 10 (maximum comfort), where higher scores indicate better comfort
Time frame: Day 2 and Day 8
Participant Scheme Preference
Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
Time frame: Day 8
Response Latency During AVSS
The response latency, defined as the time delay in seconds from the onset of Audiovisual Sexual Stimulation (AVSS) to a penile rigidity increase of more than 10%.
Time frame: Day 1
Congestion Initiation Slope During AVSS
Congestion initiation slope (rigidity change rate, % per second) reflected by deformation heatmaps during the Audiovisual Sexual Stimulation (AVSS) test.
Time frame: Day 1
Correlation with Vascular Subtyping Characteristics
Correlation analysis between morphology feature vectors from deformation heatmaps and hemodynamic parameters measured by Penile Color Doppler Ultrasound (CDDU).
Time frame: Within 1 week after monitoring.
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