Erectile Dysfunction Clinical Trial
— GJZLBQGNZAOfficial title:
Clinical Study of Liver Meridian in the Treatment of Male Impotence and Female Premature Ovarian Failure
Erectile dysfunction (ED) is a kind of worldwide and common sexual dysfunction disease, which mainly affects men over forty years old. The clinical characteristics of ED is the inability to maintain sufficient erection to obtain satisfactory sexual intercourse. Age, education, diabetes, stroke, obesity, and hypertension are factors inducing ED. Recent years, the prevalence of ED is rising, and more men aged below forty years old are suffering ED. Published review indicated that the prevalence of ED was 40.56% in Chinese men aged over forty years old. A survey conducted in China suggested that 40.56% men aged over forty years old suffered from ED. Another international survey found that, 21.48% sexually active participants suffered from ED. Several researches demonstrated that, ED affects health and quality of life of patients and partner. Besides, ED induces patients' psychosocial problems, including depression and anxiety, and reduce work efficiency. According to American Urological Association guideline published in 2018, the clinical therapies for ED include phosphodiesterase type 5 inhibitor (PDE5i), vacuum erection device, and penile prosthesis implantation. PDE5i (such as sildenafil, vardenafil, and tadalafil) is a first-line drug for ED, recommended by doctors and patients. However, the most common side effects of PDE5i were headache, dyspepsia, flushing, and blurred vision. Furthermore, the ideal dose and type of PDE5i still need to be further studied. The use of PDE5i is restricted by those reasons. Acupuncture is an important role of Traditional Chinese Medicine (TCM), and acupuncture received more concerned recently. The correlation between meridians and viscera is the center of acupuncture scientific problem. Acupoints stimulation can regulate visceral sensation and mobility to treat diseases.
Status | Recruiting |
Enrollment | 159 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 11, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 22 Years to 50 Years |
Eligibility | Inclusion Criteria: - Age between 22 and 50 years - Having a sexual partner and having regular sex life at least twice a week - Meeting the diagnostic criteria of ED - The scores of IIEF-5 between 8 points to 21 points - PDE5i or similar medication weren't taken one month before treatment - Patients agree to participate in this study. Exclusion Criteria: - Congenital genital malformation and dysplasia - Severe reproductive system infection - ED induced by genitourinary surgery and lower abdominal surgery - Severe cardiovascular disease, liver disease, kidney disease - Severe hypertension, diabetes, and blood diseases have not been controlled - Severe mental illness - Contraindications of PDE5i. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Hunan University of Chinese Medicine | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
China,
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Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5-item version of the International Index of Erectile Function (IIEF-5) | In this trial, the 5-item version of IIEF will be applied as primary outcome. The IIEF-5 contains 5 questions and measures the erectile function and intercourse satisfaction. Responses are rated on 5-point Likert scales for every item. The total scores of all 5 items are the overall IIEF-5 score. | Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) | |
Secondary | Sexual Encounter Profile (SEP) diaries | In this trial, the development of sexual activity will be assessed using the Sexual Encounter Profile (SEP) diaries (SEP-Questions 2 and 3). After each sexual intercourse, the participants will be asked to record the following two yes/no questions of the test: SEP Question 2: " Were you able to insert your penis into your partner's vagina?" SEP3 Question 3: " Did your erection last long enough for you to have successful intercourse? ". | Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) | |
Secondary | Erectile hardness grading scale (EHS) | To investigate the erectile hardness, the erectile hardness grading scale (EHS) was used in this trial. According to the EHS, the erectile hardness is divided into four grades. Grade one of EHS is that penis enlarged but not hard. Grade two of EHS is that the penis is slightly erect, but not enough for penetration. Grade three of EHS is that penis erection hard for penetration but not hard completely. Grade four of EHS is that penis is completely hard and fully rigid. | Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) | |
Secondary | Treatment satisfaction scale (TSS) | The treatment effectiveness for both patients and partners will be measured using The Treatment Satisfaction Scale (TSS) . The TSS questionnaire consist of four parts, including unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules. The content of TSS include the satisfaction with sexual spontaneity, quality of erection, quality of ejaculation, sexual pleasure, orgasm, confidence, reliability of treatment, side effects, convenience, overall satisfaction, conformity to treatment expectations and intent to continue treatment. | Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) | |
Secondary | The Hamilton Anxiety Scale (HAMA) | The symptoms of anxiety induced by ED will be evaluated by The Hamilton Anxiety Scale (HAMA) separately. The higher the score, the heavier anxiety. | Baseline period, enrollment 4 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) | |
Secondary | The Hamilton Depression Scale (HAMD) | The symptoms of depression induced by ED will be evaluated by The Hamilton Depression Scale (HAMD) separately. The higher the score, the heavier the depression. | Baseline period, enrollment 4 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up) |
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