Diagnostic Performance of a Flexible Penile Monitoring System for ED
Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction
1 other identifier
observational
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
August 13, 2026
July 1, 2026
1 year
July 28, 2026
August 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Measurement Accuracy of Peak Rigidity
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
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
Secondary Outcomes (10)
Clinical Diagnosis Agreement Rate
Day 1 and Day 8
Sleep Efficiency
Day 1 and Day 8
REM Sleep Percentage
Day 1 and Day 8
Unintended Arousal Frequency
Day 1 and Day 8
Subjective Sleep Perception Score (PSQI)
Day 2 and Day 8
- +5 more secondary outcomes
Study Arms (2)
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.
Healthy Volunteer Group
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
Interventions
A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bin Xulead
Study Sites (1)
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bin Xu
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
July 28, 2026
First Posted
August 13, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
August 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share