Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction
|ClinicalTrials.gov Identifier: NCT03359265|
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Device: underpants||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction|
|Actual Study Start Date :||November 24, 2015|
|Actual Primary Completion Date :||March 15, 2016|
|Actual Study Completion Date :||December 31, 2016|
Active Comparator: Test
The test group used underpants made of precious metal fibers (germanium, titanium and phosphorus), developed by Green Energy Nano Technology Co., Ltd.
Placebo Comparator: Control
The control group used commercially available underpants.
- The International Index of Erectile Function (IIEF-5) [ Time Frame: 3 months ]
The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
- Quality of Erection Questionnaire (QEQ) [ Time Frame: 3 months ]
The QEQ is to be evaluated as a total score, which is the sum of responses to all items transformed onto a 5-30 scale.
The maximum score on the QEQ is 30, and a higher score indicates better function.