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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-31

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.

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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.

Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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erectile dysfunction group

International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights

Rigiscan test

Intervention Type DEVICE

Rigiscan tests are performed in enrolled subjects for consecutive two nights.

control group

International Index of Erectile Function (IIEF-5) questionnaire\<22 Rigiscan test are performed for two nights

Rigiscan test

Intervention Type DEVICE

Rigiscan tests are performed in enrolled subjects for consecutive two nights.

Interventions

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Rigiscan test

Rigiscan tests are performed in enrolled subjects for consecutive two nights.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;
2. age≥20 year;
3. complete the validated International Index of Erectile Function (IIEF-5) questionnaire.

Exclusion Criteria

1. advanced age (≥65);
2. pelvic trauma
3. thyroid diseases
4. metabolic diseases
5. hypogonadism and other hormonal disorders
6. sleep disorders
7. penile deformities
8. taking drugs that may interfere with erectile function.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes