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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Procedure: Li-ESWT; Drug: Tadalafil 2.5Mg Tab

• Registration Number: NCT05043896
• Lead Sponsor: Dr. Soetomo General Hospital

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

Study Timeline

• Study Start: 2019-12-10
• Primary Completion: 2020-06-03
• Study Completion: 2020-06-30
• Study First Submitted: 2021-08-26
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination therapy	Tadalafil 2.5Mg Tab	Li-ESWT + tadalafil
Combination therapy	Li-ESWT	Li-ESWT + tadalafil
Single Therapy	Tadalafil 2.5Mg Tab	tadalafil only

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

dr. Soetomo General Hospital; 🇮🇩 Surabaya, Jawa Timur, Indonesia