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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
60
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Chao Sun
- 電話番号：+86 13813966939
- メール：fertility@126.com
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210009
- Zhongda Hospital Southeast University
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コンタクト：
- Chao Sun
- 電話番号：+86-13813966939
- メール：fertility@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurement Accuracy of Peak Rigidity
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Diagnosis Agreement Rate
時間枠：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.
|
Day 1 and Day 8
|
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Sleep Efficiency
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
Day 2 and Day 8
|
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Participant Scheme Preference
時間枠：Day 8
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Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
|
Day 8
|
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Response Latency During AVSS
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Bin Xu、Zhongda hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2027年8月1日
研究の完了 (推定)
2028年2月1日
試験登録日
最初に提出
2026年7月28日
QC基準を満たした最初の提出物
2026年8月8日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月8日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026ZDSYLL244-P01
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