An observational study in Erectile Dysfunction, sponsored by Bin Xu. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Bin Xu · Observational
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 60 is below the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Bin Xu is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Males aged 18-70 years diagnosed with erectile dysfunction (ED) for more than 6 months, with an IIEF-5 score of less than 21.
Device: Intelligent Flexible Penile Monitoring System · Device: RigiScan Plus
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
Device: Intelligent Flexible Penile Monitoring System · Device: RigiScan Plus
A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan Plus
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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