the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males (NPTR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Erectile Dysfunction | Device: Rigiscan test |
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 |

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. |
- 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)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;
- age≥20 year;
- complete the validated International Index of Erectile Function (IIEF-5) questionnaire.
Exclusion Criteria:
- advanced age (≥65);
- pelvic trauma
- thyroid diseases
- metabolic diseases
- hypogonadism and other hormonal disorders
- sleep disorders
- penile deformities
- taking drugs that may interfere with erectile function.

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
Contact: l zhu, doctor | +8602568182222 | 13770864680@163.com | |
Contact: yutian dai, doctor | +8602568182222 | 13913957628@163.com |
China, Jiangsu | |
Yutian Dai | Recruiting |
Nanjing, Jiangsu, China, 210008 |
Principal Investigator: | l zhu, doctor | Drum tower Hospital, school of Medicine, Nanjing University |
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 |
nocturnal penile tumescence and rigidity erectile dysfunction Chinese males |
Muscle Rigidity Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |