The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043896
• Other study ID #: 1690/KEPK/XII/2019
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2021
• Source: Dr. Soetomo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• Li-ESWT
Li-ESWT twice weekly for 4 weeks

Drug:
• Tadalafil 2.5Mg Tab
tadalafil 2.5mg once daily

Locations

Country	Name	City	State
Indonesia	dr. Soetomo General Hospital	Surabaya	Jawa Timur

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Hardness Score (EHS)	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; Penis is larger, but not hard; Penis is hard, but not hard enough for penetration; Penis is hard enough for penetration, but not completely hard; Penis is completely hard and fully rigid; The EHS score was taken pre and post intervention	4 weeks
Primary	International Index of Erectile Function (IIEF-5) score	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	4 weeks
Primary	Peak Systolic Velocity (PSV)	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	4 weeks
Primary	Vascular Endothelial Growth Factor (VEGF) level in plasma	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	4 weeks