The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Phase: NA
Conditions: Erectile Dysfunction
Sponsor: Dr. Soetomo General Hospital

NCT
: 1690/KEPK/XII/2019
Title
: The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor
Compared to PDE-5 Inhibitor Alone in Patients With Erectile Dysfunction
Date
: December 1, 2019

Study Protocol
4 weeks
IIEF-5, EHS, flaccid state PSV, VEGF
Test Group (Combination Therapy)
Tadalafil 2,5 mg daily at 08.00 before meal
Li-ESWT twice weekly with : energy density 0.09
mJ/mm2, frequency 5Hz, 600 pulse per location, in 5
location (corpus penis distal, medial, and proximal, crux
dextra et sinistra), 3 minutes of duration each loaction.
IIEF-5, EHS, flaccid state PSV, VEGF
IIEF-5, EHS, flaccid state PSV, VEGF
Control Group (Single therapy)
Tadalafil 2,5 mg daily at 08.00 before meal
Inclusion Criteria
(30 respondent)
Sample
Men with Erectile Dysfunction who come to Andrology Clinic
of Dr. Soetomo General Hospital
Anamnesis
Physical Diagnosis
Exclusion
Critrerias
IIEF-5, EHS, flaccid state PSV, VEGF
Population
Men with Erectile Dysfunction
15 respondentt
15 respondent
Random

 
 
 
 
Assessed for eligibility (n= 36) 
Excluded  (n= 6) 
   Not meeting inclusion criteria (n=6) 
   Declined to participate (n=0) 
   Other reasons (n=0) 
Analysed  (n=12) 
 Excluded from analysis (give reasons) (n=0) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (give reasons) (n=3) 
Reason : move to other city 
Allocated to intervention (n=15) 
 Received allocated intervention (n=15) 
 Did not receive allocated intervention (give 
reasons) (n=0) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (give reasons) (n=1) 
Reason : move to other city 
Allocated to intervention (n=15) 
 Received allocated intervention (n=15) 
 Did not receive allocated intervention (give 
reasons) (n=0) 
Analysed  (n=14) 
 Excluded from analysis (give reasons) (n=0) 
Allocation 
Analysis 
Follow-Up 
Randomized (n=30) 
Enrollment