Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction

September 8, 2020 updated by: Juin-Hong Cherng, National Defense Medical Center, Taiwan
Erectile dysfunction (ED) is common, and is defined as "persistent or regular inability to achieve or maintain penis erection for satisfactory intercourse". Approximately 3% to 71% of males have this problem as they age, and it is predicted that 320 million males worldwide will have ED by 2025. However, sex remains a topic that is too sensitive for most people to discuss openly. ED therapies include oral medication, vacuum erection devices, intracavernosal injection, testosterone supplementation, surgery, and psychological counseling. In addition, germanium (Ge), titanium (Ti), and π elements are noble metals that can be used to produce far-infrared radiation. There has been little application of these metals to the treatment of ED, but their use is worth investigating. Administered as health textiles, the application of these metals are expected to promote blood circulation, especially in the reproductive system, resulting in an improved sexual performance. Hence, the researcher aimed to investigate the safety and efficacy of Ge-Ti-π elements fiber textiles as an ED treatment, assessed by using the questionnaires related to the quality of sexual function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial recruited 30 subjects with ED (a test group of 21 subjects and a control group of 9 subjects). Cellulosic textiles, incorporating noble metals (Ge, Ti, and π elements), developed by Green Energy Nano Technology Co., Ltd, were used in the test group, while commercially available regular textiles were used in the control group. The safety and efficacy of the treatment to the subject's sexual function quality were assessed through the International Index of Erectile Function (IIEF-5) and the validated Portuguese version of the Quality of Erection Questionnaire (QEQ) questionnaires. In the same session, the symptoms related to ED were assessed through the Premature Ejaculation Diagnostic Tool (PEDT) and the International Prostate Symptom Score (IPSS) questionnaires. The questionnaires were completed once a month and followed up for 3 months. The incidence of severe adverse effects was analyzed to assess product safety.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei city, Taiwan, 114
        • National Defense of Medical Center, Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. The subject or legal representative has understood the contents of this experiment and has agreed to sign the participation consent form.
  2. The subject is aged between 40 and 70 years.
  3. The patient has a medical history of erectile dysfunction for at least three months, based on a physician's diagnosis.
  4. The subject has a regular sex partner during the experimental period.

Exclusion Criteria:

  1. Subject was administered oral medication (Sildenafil, Vardenafil, or Tadalafil), vacuum suction device, or corpus cavernosum injections, seven days before the experiment commenced.
  2. Long-term use of antihypertensive medication (doxazosin or nitrate), antidepressants, sedatives, anti-androgens, or medications such as cimetidine for digestive ulcers.
  3. Severe damage to the central nervous system (including stroke or spinal injury) within the last six months.
  4. Patients with erectile dysfunction induced by non-vascular causes, such as neurological factors, hormonal factors, or related trauma.
  5. Patients with vascular sclerosis.
  6. Patients with psychogenic erectile dysfunction.
  7. Patients who had undergone radical prostatectomy or transurethral resection of the prostate.
  8. HIV patients or patients with severe liver dysfunction (GOT, GPT ≥100 IU/L).
  9. Patients with genital malformations or diseases that require sexual abstinence.
  10. Sex partner is pregnant or nursing.
  11. Patients with Peyronie's Disease.
  12. Heavy drinkers or smokers.
  13. Patients with malignant tumors or prostate cancer.
  14. Patients who had surgery during the study period that could affect the experimental results.
  15. Subjects who had a serious clinical or mental condition that could affect the experimental procedure or evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: underpants
Placebo Comparator: Control
The control group used commercially available underpants.
Device: underpants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The International Index of Erectile Function (IIEF-5)
Time Frame: 3 months

IIEF-5 is a multidimensional validated questionnaire with 15 questions in the five domains of sexual function, such as erectile and orgasmic functions, sexual desire, satisfaction with intercourse, and overall sexual satisfaction. IIEF-5 scoring:

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
3 months
Quality of Erection Questionnaire (QEQ)
Time Frame: 3 months

QEQ is a questionnaire that provides a further level of information by assessing satisfaction with the quality of the erections that were attained and maintained. 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.
3 months
Premature Ejaculation Diagnostic Tool (PEDT)
Time Frame: 3 months
PEDT has been shown to be valid in detecting the presence of premature ejaculation among patients with five questions. Each item has a score of zero to four, and PEDT is scored by considering all five items together, which a higher score indicates highly suggestive of premature ejaculation.
3 months
International Prostate Symptom Score (IPSS)
Time Frame: 3 months
IPSS is a well-known questionnaire to evaluate the symptom of prostate disease in patients. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2015

Primary Completion (Actual)

June 15, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GREEN888

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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