Erectile DysfunctionNCT07762469
Diagnostic Performance of a Flexible Penile Monitoring System for ED
An observational study of Erectile Dysfunction, run by Bin Xu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Intelligent Flexible Penile Monitoring System and RigiScan Plus
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Chao Sun, +86-13813966939, fertility@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Intelligent Flexible Penile Monitoring System, RigiScan Plus
- Keywords
- Nocturnal Penile Tumescence, Flexible Sensor, Wearable Device, RigiScan, Diagnostic Performance
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Flexible Penile Monitoring SystemDevice
A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
RigiScan PlusDevice
RigiScan Plus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intelligent Flexible Penile Monitoring System; Device: 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. Receives: Device: Intelligent Flexible Penile Monitoring System; Device: RigiScan Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Accuracy of Peak Rigidity
Mean bias and 95% limits of agreement for peak rigidity (%) between the novel flexible system and RigiScan Plus.
Measured: 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.
Measured: Day 1 and Day 8
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 2 and Day 8
Participant Scheme Preference
Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
Measured: 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%.
Measured: 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.
Measured: 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).
Measured: Within 1 week after monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Xu, Zhongda Hospital
- Investigators
- Bin Xu, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762469
- Sponsor's protocol ID
- 2026ZDSYLL244-P01
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07762469
- Acronym / sponsor ID
- 2026ZDSYLL244-P01
- Conditions
- Erectile Dysfunction
- Keywords
- Nocturnal Penile Tumescence, Flexible Sensor, Wearable Device, RigiScan, Diagnostic Performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bin XuUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED Patient Group | – | Device: Intelligent Flexible Penile Monitoring System, Device: RigiScan PlusMales aged 18-70 years diagnosed with erectile dysfunction (ED) for more than 6 months, with an IIEF-5 score of less than 21. |
| Healthy Volunteer Group | – | Device: Intelligent Flexible Penile Monitoring System, Device: RigiScan PlusHealthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Flexible Penile Monitoring SystemA novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep. | Device | ED Patient Group, Healthy Volunteer Group |
| RigiScan PlusRigiScan Plus | Device | ED Patient Group, Healthy Volunteer Group |
Primary outcome
Measurement Accuracy of Peak Rigidity
Time frame: 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
Time frame: 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.
10 secondary outcomes
Clinical Diagnosis Agreement Rate
Time frame: Day 1 and Day 8
Sleep Efficiency
Time frame: Day 1 and Day 8
REM Sleep Percentage
Time frame: Day 1 and Day 8
Unintended Arousal Frequency
Time frame: Day 1 and Day 8
Subjective Sleep Perception Score (PSQI)
Time frame: Day 2 and Day 8
Subjective Wearing Comfort Score
Time frame: Day 2 and Day 8
Participant Scheme Preference
Time frame: Day 8
Response Latency During AVSS
Time frame: Day 1
Congestion Initiation Slope During AVSS
Time frame: Day 1
Correlation with Vascular Subtyping Characteristics
Time frame: Within 1 week after monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Xu study chair
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Bin Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Sun (+86 13813966939, fertility@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement Accuracy of Peak Rigidity (time frame: Day 1 and Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.