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

NCT03359265 | Completed

• 1 other identifier: GREEN888
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Test

ACTIVE COMPARATOR

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

Device: underpants

Control

PLACEBO COMPARATOR

The control group used commercially available underpants.

Device: underpants

Interventions

underpants DEVICE

Control; Test

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

National Defense of Medical Center, Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 26320382 BACKGROUND

• 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.

  PMID: 17275456 BACKGROUND

• 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.

  PMID: 21076440 BACKGROUND

• 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.

  PMID: 11035380 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 2, 2017
• Study Start: November 25, 2015
• Primary Completion: June 15, 2016
• Study Completion: December 31, 2016
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

TW (1)