A Prospective, clinical study to evaluate the efficacy of glans penis augmentation using hyaluronic acid filler in management of premature ejaculation; pilot study
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0005433
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Male
- Target Recruitment
- 20
1. Koreans who voluntarily decide to participate in this clinical trial and give written consent after hearing and understanding the detailed explanation of the characteristics of this clinical trial and medical devices for clinical trials
2. Adult males aged 19 to 65 years old
3. Patients who have had regular sex with the opposite sex (including married spouse) for more than 6 months and plan to maintain this during the test period
4.Premature ejaculation history as defined by (DSM)-V
5. During the run-in period, there is a willingness to try at least 4 intercourse during 4 different days, and in 3 or more out of 4 intercourse, that is, over 75% of sexual activity on average ? Lifelong premature ejaculation is 1 minute in IELT Below ?Acquired premature ejaculation is less than 3 minutes in IELT, and in the Sexual History survey, item 9 -'Acquired', item 11-If you answered'Yes'
6. More than 11 points on the Korean version of Premature Ejaculation Diagnosis (PEDT)
7. Subjects who understand the contents of the clinical trial and are cooperative (those who strive to perform sexual intercourse more than 4 times between each visit and are willing to postpone the pre-scheduled selective surgery) and are judged to be able to participate until the end of the clinical trial
8. Those who can communicate (except those who are illiterate or who cannot understand the questionnaire and questionnaire questions) 9. Those who are willing to complete the study subject diary card (do not fill out the study subject diary card sufficiently during the screening period) Patients are excluded.) 10. Those who agree to enlarge the glans regardless of the size of the glans 11. Those who agree to stop other treatments or treatments for glans enlargement during the trial period 12. Those who have undergone circumcision or have not received circumcision. Even if the penis is relaxed and the foreskin does not cover the glans 13. A person who has consented to abstinence (sex, masturbation, etc.) for at least 1 month after the treatment of a medical device for clinical trials 14. A person who can understand and follow the instructions
1.If you have a history of neurological diseases, infections (chronic prostatitis, urethritis),
injury, surgery (pelvic or spine), etc. If this medical history is currently determined to be related to premature ejaculation,
or if the drug history is currently determined to be related to premature ejaculation
2. Those who received hyaluronic acid filler injection into the glans within 2 years from the time of screening
3. Subjects judged by the investigator to be unsuitable for participation in the test, such as any unstable medical condition, mental or alcohol and substance abuse abnormalities (based on the last 6 months)
4. If the female partner has decreased interest in sexual intercourse or has sexual dysfunction such as dyspareunia 5. If the female partner is pregnant
6. Those who tend to bleed or who cannot stop the administration of anticoagulants or antiplatelet agents from 2 weeks before the treatment of the clinical trial medical device to 2 weeks after the treatment (however, administration of low doses (less than 300mg/day) of aspirin is allowed.)
7. Persons who have undergone penile dorsal nerve dissection for the purpose of treating premature ejaculation in the past
8. Those who have received penile augmentation surgery (fat, replacement dermal transplantation) in the past (however, 2 years have passed since the transplantation of hyaluronic acid or collagen, and surgeons for penile length extension such as superpubic fat resection and suspension ligament resection. If so, allow it.)
9. Patients unable to perform clinical trial medical devices due to penile deformities (Peyronie's disease) 10. Patients with a history of anaphylaxis or severe allergy symptoms
11. Those with a history of hypertrophic scars or keloids
12. A person who has had side effects from a local anesthetic (EMLA Cream or equivalent lidocaine) in the past 13. A person who has hypersensitivity to hyaluronic acid
14. Those with inflammatory and/or infectious diseases that are judged to affect clinical trials in the glans.
15. Those who have had or currently have benign or malignant tumors, lymphogranuloma venereum, or sexually transmitted diseases in the past
16. Those who have a history of autoimmune diseases or receive immunotherapy
17. In addition to the above, A person who has clinically significant findings deemed inappropriate for this test as it is medically judged by the investigator or the person in charge of the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change in IELT
- Secondary Outcome Measures
Name Time Method Score change by item for 4 PEP items (sum or average);Average change in total sum of PEDT scores;Among PGICs, response rates of'improved' or higher or'much improved' or higher;Difference value from baseline of glans circumference