Erectile Dysfunction
Conditions
Keywords
Nocturnal Penile Tumescence, Flexible Sensor, Wearable Device, RigiScan, Diagnostic Performance
Brief 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.
Detailed description
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.
Interventions
DEVICEIntelligent Flexible Penile Monitoring System
A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
DEVICERigiScan Plus
RigiScan Plus
Sponsors
Bin Xu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Accuracy of Peak Rigidity | Day 1 and Day 8 | Mean bias and 95% limits of agreement for peak rigidity (%) between the novel flexible system and RigiScan Plus. |
| Measurement Accuracy of Maximum Girth Expansion | Day 1 and Day 8 | Mean bias and 95% limits of agreement for maximum girth expansion (cm) between the novel flexible system and RigiScan Plus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Diagnosis Agreement Rate | Day 1 and Day 8 | The degree of agreement in diagnostic conclusions (normal, psychogenic, or organic ED) between the two systems, evaluated using Cohen's Kappa coefficient. |
| Sleep Efficiency | Day 1 and Day 8 | 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. |
| REM Sleep Percentage | Day 1 and Day 8 | Percentage of total sleep time spent in the Rapid Eye Movement (REM) sleep stage (%), measured by a medical-grade sleep recorder. |
| Unintended Arousal Frequency | Day 1 and Day 8 | Frequency of unintended arousals (number of events per hour) during sleep, measured by a medical-grade sleep recorder. |
| Subjective Sleep Perception Score (PSQI) | Day 2 and Day 8 | 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. |
| Subjective Wearing Comfort Score | Day 2 and Day 8 | 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 |
| Participant Scheme Preference | Day 8 | Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus. |
| Response Latency During AVSS | Day 1 | 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%. |
| Congestion Initiation Slope During AVSS | Day 1 | Congestion initiation slope (rigidity change rate, % per second) reflected by deformation heatmaps during the Audiovisual Sexual Stimulation (AVSS) test. |
| Correlation with Vascular Subtyping Characteristics | Within 1 week after monitoring. | Correlation analysis between morphology feature vectors from deformation heatmaps and hemodynamic parameters measured by Penile Color Doppler Ultrasound (CDDU). |
Countries
China
Contacts
CONTACTChao Sun
STUDY_CHAIRBin Xu
Zhongda Hospital
Outcome results
None listed