An observational study in Erectile Dysfunction, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to male participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
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.
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.
698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 135 across 120 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 248 studies on the registry; 146 are open to participants now.
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Chinese males ≥20 years
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Exclusion Criteria:
International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights
Device: Rigiscan test
International Index of Erectile Function (IIEF-5) questionnaire\<22 Rigiscan test are performed for two nights
Device: Rigiscan test
Rigiscan tests are performed in enrolled subjects for consecutive two nights.
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)
Time frame: within 2 days after the Rigiscan test
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 (%)
Time frame: within 2 days after the Rigiscan test
The record gives a start of Sep 2015, a primary completion of Aug 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →