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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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 Summary: 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.
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Current Primary Outcome: Previous Rigiscan parameters analyzed by Rigiscan plus software [ Time Frame: within 2 days after the Rigiscan test ]

number of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min)


Original Primary Outcome: Rigiscan parameters analyzed by Rigiscan plus software [ Time Frame: within 2 days after the Rigiscan test ]

Current Secondary Outcome: newly developed Rigiscan parameters analyzed by Rigiscan plus software [ Time Frame: within 2 days after the Rigiscan test ]

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 (%)


Original Secondary Outcome:

Information By: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Dates:
Date Received: October 9, 2015
Date Started: September 2015
Date Completion: October 2016
Last Updated: October 10, 2015
Last Verified: October 2015