Viewing Study NCT02573805


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Study NCT ID: NCT02573805
Status: UNKNOWN
Last Update Posted: 2015-10-14
First Post: 2015-10-09
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:

Study Overview

Official Title: the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Status: UNKNOWN
Status Verified Date: 2015-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NPTR
Brief Summary: 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: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: