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

Erectile Dysfunction Clinical Trial

— NPTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02573805
• Other study ID #: NPTR in 2015-09-24
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 10, 2015
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: l zhu, doctor
• Phone: +8602568182222
• Email: 13770864680[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Rigiscan test
Rigiscan tests are performed in enrolled subjects for consecutive two nights.

Locations

Country	Name	City	State
China	Yutian Dai	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	within 2 days after the Rigiscan test	No
Secondary	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 (%)	within 2 days after the Rigiscan test	No