Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:• Age 20 to 45; Married or have had a permanent sex partner for at least 3 months; IIEF-5 questionnaire scores below 20 Exclusion Criteria: History of previous use of PDE-5 inhibitors or fSWT; Patients with diabetes mellitus; Patients after the radical prostatectomy or major pelvic surgery; Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury); Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;
Sites / Locations
- SBPSURecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Medication group
Combination group
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month plus Device BTL-6000 fSWT: 6 sessions with EFD 0,09 mJ/mm2 by 5000 impulses per session in 5 points in corpora cavernosa penis