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Study on the effectiveness of DL-scan penile hardness tester in diagnosing erectile dysfunction

Study on the effectiveness of DL-scan penile hardness tester in diagnosing erectile dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093616
Enrollment
Unknown
Registered
2024-12-09
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction

Interventions

Gold Standard:The Rigiscan detector is a recognized objective method for distinguishing psychological ED from organic ED and is the gold standard for diagnosing ED. Internationally, Rigiscan is one of
When the circumference increases by more than 6mm, the recorder will change the tension and collect hardness data of the root and head every 30 seconds. Adult males may experience 3-6 unconscious peni
Index test:Domestic Nighttime Erectile Function Tester DL scan

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) 18<= age <= 60 years old, (2) patients clinically diagnosed with erectile dysfunction; (3) The International Index of Erectile Function score (IIEF-5) is <= 21 points (see Appendix for diagnostic reference); (4) Having a fixed sexual partner and normal sexual desire; (5) Patients with unclear etiology of ED; (6) Patients who have not responded to previous treatments and require further treatment; (7) Patients planning to undergo surgical treatment for ED; (8) For patients with suspected psychological causes; (9) Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial.

Exclusion criteria

Exclusion criteria: (1) Asexual life; (2) Complicated with urethritis, acute prostatitis, diabetes; (3) Individuals with abnormal development of internal and external genitalia; (4) Patients with other serious systemic diseases, such as severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, hematological disorders, mental illnesses, malignant tumors, etc; (5) Patients with poor compliance, failure to receive treatment as prescribed, or mental or consciousness disorders that prevent them from cooperating with treatment independently; (6) Patients with erectile dysfunction or organic erectile dysfunction caused by traumatic penile injury; (7) Long term use of drugs that affect sexual function in patients; (8) In addition to the above, the researchers have determined that patients who are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Baseline information;IIEF-5 rating;Number of penile erectionstions;Total duration of erection;Head hardness = 60% duration;Root hardness = 60% duration;Percentage change in head circumference;Percentage change in root circumference;Time intensity measurement value;True positive rate;True negative rate;False positive rate;False negative rate;Youden index;Consistency;

Countries

China

Contacts

Public ContactDongjie Li

Xiangya Hospital, Central South University

dongjieli@csu.edu.cn+86 137 5501 1481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026