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

• Conditions: Erectile Dysfunction
• Interventions: Device: Rigiscan test

• Registration Number: NCT02573805
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Last Update Submitted: 2015-10-10
• Study First Posted: 2015-10-12
• Last Update Posted: 2015-10-14
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
erectile dysfunction group	Rigiscan test	International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights
control group	Rigiscan test	International Index of Erectile Function (IIEF-5) questionnaire\<22 Rigiscan test are performed for two nights

Primary Outcome Measures

Name	Time	Method
Previous Rigiscan parameters analyzed by Rigiscan plus software	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)

Secondary Outcome Measures

Name	Time	Method
newly developed Rigiscan parameters analyzed by Rigiscan plus software	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 (%)

Trial Locations

Locations (1)

Yutian Dai; 🇨🇳 Nanjing, Jiangsu, China