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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359265
• Other study ID #: GREEN888
• Status: Completed
• Phase: N/A
• Start date: November 25, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2020
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2016
• Est. primary completion date: June 15, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• underpants

Locations

Country	Name	City	State
Taiwan	National Defense of Medical Center, Tri-Service General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. Review. — View Citation

McKinlay JB. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res. 2000 Oct;12 Suppl 4:S6-S11. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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).	3 months