Erectile Dysfunction
Conditions
Brief summary
to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients
Detailed description
Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients. Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
Interventions
PROCEDURELi-ESWT
Li-ESWT twice weekly for 4 weeks
DRUGTadalafil 2.5Mg Tab
tadalafil 2.5mg once daily
Sponsors
Dr. Soetomo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Mild to Moderate Erectile dysfunction * Married * Sexually active * Consenting to participate in the trial
Exclusion criteria
* Psychological problems * Spinal injury * History of malignancy * Penile anatomy abnormalities * Allergic and Contraindications to tadalafil * On anti-mitotic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Hardness Score (EHS) | 4 weeks | Developed in 1998, the EHS is a single-item Likert scale that men can use on their own. The tool asks them to consider the question How would you rate the hardness of your erection? and select one of the following options: 0 Penis does not enlarge 1. Penis is larger, but not hard 2. Penis is hard, but not hard enough for penetration 3. Penis is hard enough for penetration, but not completely hard 4. Penis is completely hard and fully rigid The EHS score was taken pre and post intervention |
| International Index of Erectile Function (IIEF-5) score | 4 weeks | IIEF-5 is a tool for ED (Erectile Dysfunction)diagnosis. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25) IIEF-5 score was taken pre and post intervention |
| Peak Systolic Velocity (PSV) | 4 weeks | PSV was measured in cm/s, by using Doppler Ultrasonography. The probe is located at the penis, to be precise in the penoscrotal junction, to measure the velocity of the blood flow in the cavernous arteries. The test was done in flaccid state of the penis Measurement was taken by an experienced ultrasonographer in the radiology unit. Measurement was taken pre and post intervention |
| Vascular Endothelial Growth Factor (VEGF) level in plasma | 4 weeks | VEGF was measured in pg/ml. VEGF test were done by blood test in the laboratory using the VEGF-A ELISA Kit. Blood for tests were drawn pre and post test |
Countries
Indonesia
Outcome results
None listed