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

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ClinicalTrials.gov Identifier: NCT02573805
Recruitment Status : Unknown
Verified October 2015 by Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : October 12, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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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.

Condition or disease Intervention/treatment
Erectile Dysfunction Device: Rigiscan test

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Study Start Date : September 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
erectile dysfunction group
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.
control group
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 (%)


Biospecimen Retention:   None Retained
Rigiscan parameters analyzed by Rigiscan plus software

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chinese males ≥20 years
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573805


Contacts
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Contact: l zhu, doctor +8602568182222 13770864680@163.com
Contact: yutian dai, doctor +8602568182222 13913957628@163.com

Locations
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China, Jiangsu
Yutian Dai Recruiting
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: l zhu, doctor Drum tower Hospital, school of Medicine, Nanjing University
More Information
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Additional Information:

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Responsible Party: Leilei Zhu, doctor leilei zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02573805    
Other Study ID Numbers: NPTR in 2015-09-24
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
nocturnal penile tumescence and rigidity
erectile dysfunction
Chinese males
Additional relevant MeSH terms:
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Muscle Rigidity
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Muscular Diseases
 Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms