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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

underpants

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National Defense of Medical Center, Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test

Control

Arm Description

The test group used underpants made of precious metal fibers (germanium, titanium and phosphorus), developed by Green Energy Nano Technology Co., Ltd.

The control group used commercially available underpants.

Outcomes

Primary Outcome Measures

The International Index of Erectile Function (IIEF-5)

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

Quality of Erection Questionnaire (QEQ)

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.

Premature Ejaculation Diagnostic Tool (PEDT)

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.

International Prostate Symptom Score (IPSS)

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03359265

First Posted

November 17, 2017

Last Updated

September 8, 2020

Sponsor

National Defense Medical Center, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03359265

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 25, 2015 (Actual)

Primary Completion Date

June 15, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test

Arm Type

Active Comparator

Arm Description

The test group used underpants made of precious metal fibers (germanium, titanium and phosphorus), developed by Green Energy Nano Technology Co., Ltd.

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

The control group used commercially available underpants.

Intervention Type

Device

Intervention Name(s)

underpants

Primary Outcome Measure Information:

Title

The International Index of Erectile Function (IIEF-5)

Description

Time Frame

3 months

Title

Quality of Erection Questionnaire (QEQ)

Description

Time Frame

3 months

Title

Premature Ejaculation Diagnostic Tool (PEDT)

Description

Time Frame

3 months

Title

International Prostate Symptom Score (IPSS)

Description

Time Frame

3 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject or legal representative has understood the contents of this experiment and has agreed to sign the participation consent form. The subject is aged between 40 and 70 years. The patient has a medical history of erectile dysfunction for at least three months, based on a physician's diagnosis. The subject has a regular sex partner during the experimental period. Exclusion Criteria: Subject was administered oral medication (Sildenafil, Vardenafil, or Tadalafil), vacuum suction device, or corpus cavernosum injections, seven days before the experiment commenced. Long-term use of antihypertensive medication (doxazosin or nitrate), antidepressants, sedatives, anti-androgens, or medications such as cimetidine for digestive ulcers. Severe damage to the central nervous system (including stroke or spinal injury) within the last six months. Patients with erectile dysfunction induced by non-vascular causes, such as neurological factors, hormonal factors, or related trauma. Patients with vascular sclerosis. Patients with psychogenic erectile dysfunction. Patients who had undergone radical prostatectomy or transurethral resection of the prostate. HIV patients or patients with severe liver dysfunction (GOT, GPT ≥100 IU/L). Patients with genital malformations or diseases that require sexual abstinence. Sex partner is pregnant or nursing. Patients with Peyronie's Disease. Heavy drinkers or smokers. Patients with malignant tumors or prostate cancer. Patients who had surgery during the study period that could affect the experimental results. Subjects who had a serious clinical or mental condition that could affect the experimental procedure or evaluation.

Facility Information:

Facility Name

National Defense of Medical Center, Tri-Service General Hospital

City

Taipei city

ZIP/Postal Code

114

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26320382

Citation

Puppo V, Puppo G. Re: K. Hatzimouratidis, I. Eardley, F. Giuliano, et al. Guidelines on Male Sexual Dysfunction: Erectile Dysfunction and Premature Ejaculation. The Netherlands: European Association of Urology; 2015. http://uroweb.org/guideline/male-sexual-dysfunction/. Eur Urol. 2015 Dec;68(6):e136-7. doi: 10.1016/j.eururo.2015.08.026. Epub 2015 Aug 28. No abstract available.

Results Reference

background

PubMed Identifier

17275456

Citation

Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007 Feb;120(2):151-7. doi: 10.1016/j.amjmed.2006.06.010.

Results Reference

background

PubMed Identifier

21076440

Citation

Lewis RW. Epidemiology of sexual dysfunction in Asia compared to the rest of the world. Asian J Androl. 2011 Jan;13(1):152-8. doi: 10.1038/aja.2010.108. Epub 2010 Nov 15.

Results Reference

background

PubMed Identifier

11035380

Citation

McKinlay JB. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res. 2000 Oct;12 Suppl 4:S6-S11. doi: 10.1038/sj.ijir.3900567.

Results Reference

background

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

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