the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.

Detailed Description
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The Rigiscan test is used to evaluate the NPTR parameters. The normal NPTR parameter is provided by the Rigiscan manufacturer based on a clinical study on 500 American males. Original studies of NPTR parameters on Chinese males are warranted. On the other hand, during the past decades, several new NPTR parameters have been developed, like tip TAU (tip tumescence activity units), tip RAU (tip rigidity activity units), base TAU (base tumescence activity units), base RAU (base rigidity activity units), but their diagnostic values have been less evaluated. Basd on the these background, we determined to observe the clinical manifestation of these new parameters and to establish the normal criteria of NPTR parameters in Chinese males. This could be clinically beneficial in the differential diagnosis of organic and psychological erectile dysfunction.

Official Title
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the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Rigiscan test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months; age≥20 year; complete the validated International Index of Erectile Function (IIEF-5) questionnaire. Exclusion Criteria: advanced age (≥65); pelvic trauma thyroid diseases metabolic diseases hypogonadism and other hormonal disorders sleep disorders penile deformities taking drugs that may interfere with erectile function.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| erectile dysfunction group<br>International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights | Device: Rigiscan test<br>* Rigiscan tests are performed in enrolled subjects for consecutive two nights.<br>|
| control group<br>International Index of Erectile Function (IIEF-5) questionnaire<22 Rigiscan test are performed for two nights | Device: Rigiscan test<br>* Rigiscan tests are performed in enrolled subjects for consecutive two nights.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Previous Rigiscan parameters analyzed by Rigiscan plus software | number of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min) | within 2 days after the Rigiscan test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newly developed Rigiscan parameters analyzed by Rigiscan plus software | RAU tip, TAU tip, RAU base, TAU base, average tip tumescence (cm), average base tumescence(cm), average event rigidity of tip (%),aveage event rigidity of base (%) | within 2 days after the Rigiscan test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nocturnal penile tumescence and rigidity, erectile dysfunction, Chinese males