Diagnostic Performance of a Flexible Penile Monitoring System for ED
8 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
60
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chao Sun
- Numéro de téléphone: +86 13813966939
- E-mail: fertility@126.com
Lieux d'étude
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Jiangsu
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Nanjing, Jiangsu, Chine, 210009
- Zhongda Hospital Southeast University
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Contact:
- Chao Sun
- Numéro de téléphone: +86-13813966939
- E-mail: fertility@126.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
|
Healthy Volunteer Group
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
|
A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measurement Accuracy of Peak Rigidity
Délai: Day 1 and Day 8
|
Mean bias and 95% limits of agreement for peak rigidity (%) between the novel flexible system and RigiScan Plus.
|
Day 1 and Day 8
|
|
Measurement Accuracy of Maximum Girth Expansion
Délai: 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.
|
Day 1 and Day 8
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Diagnosis Agreement Rate
Délai: 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.
|
Day 1 and Day 8
|
|
Sleep Efficiency
Délai: 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.
|
Day 1 and Day 8
|
|
REM Sleep Percentage
Délai: 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.
|
Day 1 and Day 8
|
|
Unintended Arousal Frequency
Délai: Day 1 and Day 8
|
Frequency of unintended arousals (number of events per hour) during sleep, measured by a medical-grade sleep recorder.
|
Day 1 and Day 8
|
|
Subjective Sleep Perception Score (PSQI)
Délai: 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.
|
Day 2 and Day 8
|
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Subjective Wearing Comfort Score
Délai: 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
|
Day 2 and Day 8
|
|
Participant Scheme Preference
Délai: Day 8
|
Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
|
Day 8
|
|
Response Latency During AVSS
Délai: 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%.
|
Day 1
|
|
Congestion Initiation Slope During AVSS
Délai: Day 1
|
Congestion initiation slope (rigidity change rate, % per second) reflected by deformation heatmaps during the Audiovisual Sexual Stimulation (AVSS) test.
|
Day 1
|
|
Correlation with Vascular Subtyping Characteristics
Délai: Within 1 week after monitoring.
|
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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Bin Xu, Zhongda hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 août 2027
Achèvement de l'étude (Estimé)
1 février 2028
Dates d'inscription aux études
Première soumission
28 juillet 2026
Première soumission répondant aux critères de contrôle qualité
8 août 2026
Première publication (Réel)
13 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 août 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026ZDSYLL244-P01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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