Status:
COMPLETED
Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction
Lead Sponsor:
National Defense Medical Center, Taiwan
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-55 years
Phase:
NA
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 ...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03359265
Start Date
November 25 2015
End Date
December 31 2016
Last Update
September 9 2020
Active Locations (1)
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1
National Defense of Medical Center, Tri-Service General Hospital
Taipei, Taiwan, 114