Diagnostic Performance of a Flexible Penile Monitoring System for ED
2026年8月8日 更新者：Bin Xu
Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Chao Sun
- 电话号码：+86 13813966939
- 邮箱：fertility@126.com
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国、210009
- Zhongda Hospital Southeast University
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接触：
- Chao Sun
- 电话号码：+86-13813966939
- 邮箱：fertility@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
The study population consists of adult males (18-70 years old) visiting the Urology Outpatient Clinic of Zhongda Hospital with complaints of erectile dysfunction, as well as healthy male volunteers recruited from the community.
描述
Inclusion Criteria:
- Males aged 18-70 years with good communication and compliance.
- Able to follow clinical Standard Operating Procedures (SOPs) and complete two-stage nocturnal monitoring and clinic-induced tests.
- Fully informed about the study and signed the informed consent form.
- For ED Group: Clinically diagnosed with erectile dysfunction with an IIEF-5 score < 21.
- For Healthy Group: Normal erectile function, no history of related physiological diseases or sexual psychological disorders, with an IIEF-5 score ≥ 21.
Exclusion Criteria:
- Systemic diseases: Severe cardiovascular disease (e.g., recent myocardial infarction, unstable angina), uncontrolled severe diabetes, or severe obstructive sleep apnea syndrome.
- 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.
- Skin and allergy factors: Active infection or eczema in the penile area, or known allergy to flexible materials (medical-grade silicone/adhesives).
- Mental and psychological factors: Untreated or unstable severe depression, anxiety, or other mental disorders.
- Medication interference: Current use of PDE5 inhibitors, androgens, anti-androgens, or drugs that significantly interfere with REM sleep structure.
- Other factors: Currently participating in other interventional clinical trials, or judged by researchers to have poor compliance.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
ED Patient Group
Males aged 18-70 years diagnosed with erectile dysfunction (ED) for more than 6 months, with an IIEF-5 score of less than 21.
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A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
|
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Healthy Volunteer Group
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
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A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measurement Accuracy of Peak Rigidity
大体时间：Day 1 and Day 8
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Mean bias and 95% limits of agreement for peak rigidity (%) between the novel flexible system and RigiScan Plus.
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Day 1 and Day 8
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Measurement Accuracy of Maximum Girth Expansion
大体时间：Day 1 and Day 8
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Mean bias and 95% limits of agreement for maximum girth expansion (cm) between the novel flexible system and RigiScan Plus.
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Day 1 and Day 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical Diagnosis Agreement Rate
大体时间：Day 1 and Day 8
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The degree of agreement in diagnostic conclusions (normal, psychogenic, or organic ED) between the two systems, evaluated using Cohen's Kappa coefficient.
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Day 1 and Day 8
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Sleep Efficiency
大体时间：Day 1 and Day 8
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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.
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Day 1 and Day 8
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REM Sleep Percentage
大体时间：Day 1 and Day 8
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Percentage of total sleep time spent in the Rapid Eye Movement (REM) sleep stage (%), measured by a medical-grade sleep recorder.
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Day 1 and Day 8
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Unintended Arousal Frequency
大体时间：Day 1 and Day 8
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Frequency of unintended arousals (number of events per hour) during sleep, measured by a medical-grade sleep recorder.
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Day 1 and Day 8
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Subjective Sleep Perception Score (PSQI)
大体时间：Day 2 and Day 8
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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.
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Day 2 and Day 8
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Subjective Wearing Comfort Score
大体时间：Day 2 and Day 8
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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
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Day 2 and Day 8
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Participant Scheme Preference
大体时间：Day 8
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Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
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Day 8
|
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Response Latency During AVSS
大体时间：Day 1
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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%.
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Day 1
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Congestion Initiation Slope During AVSS
大体时间：Day 1
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Congestion initiation slope (rigidity change rate, % per second) reflected by deformation heatmaps during the Audiovisual Sexual Stimulation (AVSS) test.
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Day 1
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Correlation with Vascular Subtyping Characteristics
大体时间：Within 1 week after monitoring.
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Correlation analysis between morphology feature vectors from deformation heatmaps and hemodynamic parameters measured by Penile Color Doppler Ultrasound (CDDU).
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Within 1 week after monitoring.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Bin Xu、Zhongda hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年8月1日
研究完成 (估计的)
2028年2月1日
研究注册日期
首次提交
2026年7月28日
首先提交符合 QC 标准的
2026年8月8日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月8日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026ZDSYLL244-P01
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