Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Measurement Accuracy of Peak Rigidity
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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 <
- •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.
Arms & Interventions
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.
Intervention: RigiScan Plus (Device)
Healthy Volunteer Group
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
Intervention: Intelligent Flexible Penile Monitoring System (Device)
Healthy Volunteer Group
Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.
Intervention: RigiScan Plus (Device)
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.
Intervention: Intelligent Flexible Penile Monitoring System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Subjective Wearing Comfort Score(Day 2 and Day 8)
- Participant Scheme Preference(Day 8)
- Response Latency During AVSS(Day 1)
- Congestion Initiation Slope During AVSS(Day 1)
- Correlation with Vascular Subtyping Characteristics(Within 1 week after monitoring.)
Investigators
Bin Xu
Chief Physician
Zhongda Hospital