Health TrialsbyHealthPanel

Diagnostic Performance of a Flexible Penile Monitoring System for ED

ConditionErectile Dysfunction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-70
SponsorBin Xu

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intelligent Flexible Penile Monitoring System

    Device

    A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.

  • RigiScan Plus

    Device

    RigiScan Plus

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ED Patient Group2 interventions
Group B: Healthy Volunteer Group2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bin Xu

Lead sponsor

Zhongda Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: