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Diagnostic Performance of a Flexible Penile Monitoring System for ED

8. august 2026 opdateret af: Bin Xu

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210009
        • Zhongda Hospital Southeast University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  1. Males aged 18-70 years with good communication and compliance.
  2. Able to follow clinical Standard Operating Procedures (SOPs) and complete two-stage nocturnal monitoring and clinic-induced tests.
  3. Fully informed about the study and signed the informed consent form.
  4. For ED Group: Clinically diagnosed with erectile dysfunction with an IIEF-5 score < 21.
  5. For Healthy Group: Normal erectile function, no history of related physiological diseases or sexual psychological disorders, with an IIEF-5 score ≥ 21.

Exclusion Criteria:

  1. Systemic diseases: Severe cardiovascular disease (e.g., recent myocardial infarction, unstable angina), uncontrolled severe diabetes, or severe obstructive sleep apnea syndrome.
  2. 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.
  3. Skin and allergy factors: Active infection or eczema in the penile area, or known allergy to flexible materials (medical-grade silicone/adhesives).
  4. Mental and psychological factors: Untreated or unstable severe depression, anxiety, or other mental disorders.
  5. Medication interference: Current use of PDE5 inhibitors, androgens, anti-androgens, or drugs that significantly interfere with REM sleep structure.
  6. Other factors: Currently participating in other interventional clinical trials, or judged by researchers to have poor compliance.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: Intelligent Flexible Penile Monitoring System
A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
Enhed: RigiScan Plus
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.
Enhed: Intelligent Flexible Penile Monitoring System
A novel, ultra-thin (<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.
Enhed: RigiScan Plus
RigiScan Plus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement Accuracy of Peak Rigidity
Tidsramme: Day 1 and Day 8
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
Tidsramme: 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.
Day 1 and Day 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Diagnosis Agreement Rate
Tidsramme: Day 1 and Day 8
The degree of agreement in diagnostic conclusions (normal, psychogenic, or organic ED) between the two systems, evaluated using Cohen's Kappa coefficient.
Day 1 and Day 8
Sleep Efficiency
Tidsramme: Day 1 and Day 8
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.
Day 1 and Day 8
REM Sleep Percentage
Tidsramme: Day 1 and Day 8
Percentage of total sleep time spent in the Rapid Eye Movement (REM) sleep stage (%), measured by a medical-grade sleep recorder.
Day 1 and Day 8
Unintended Arousal Frequency
Tidsramme: Day 1 and Day 8
Frequency of unintended arousals (number of events per hour) during sleep, measured by a medical-grade sleep recorder.
Day 1 and Day 8
Subjective Sleep Perception Score (PSQI)
Tidsramme: Day 2 and Day 8
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.
Day 2 and Day 8
Subjective Wearing Comfort Score
Tidsramme: Day 2 and Day 8
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
Day 2 and Day 8
Participant Scheme Preference
Tidsramme: Day 8
Number of participants who express a final preference for the flexible monitoring system versus RigiScan Plus.
Day 8
Response Latency During AVSS
Tidsramme: Day 1
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%.
Day 1
Congestion Initiation Slope During AVSS
Tidsramme: Day 1
Congestion initiation slope (rigidity change rate, % per second) reflected by deformation heatmaps during the Audiovisual Sexual Stimulation (AVSS) test.
Day 1
Correlation with Vascular Subtyping Characteristics
Tidsramme: Within 1 week after monitoring.
Correlation analysis between morphology feature vectors from deformation heatmaps and hemodynamic parameters measured by Penile Color Doppler Ultrasound (CDDU).
Within 1 week after monitoring.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bin Xu

Efterforskere

  • Studiestol: Bin Xu, Zhongda hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

28. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. august 2026

Først opslået (Faktiske)

13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026ZDSYLL244-P01

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