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

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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Procedure: Li-ESWT; Drug: Tadalafil 2.5Mg Tab

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Timur
    • Surabaya, Jawa Timur, Indonesia, 60286
      • Dr. Soetomo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination therapy; Li-ESWT + tadalafil	Procedure: Li-ESWT; Li-ESWT twice weekly for 4 weeks; Other Names: Shockwave Therapy; Drug: Tadalafil 2.5Mg Tab; tadalafil 2.5mg once daily; Other Names: Standard First Line Therapy
Sham Comparator: Single Therapy; tadalafil only	Drug: Tadalafil 2.5Mg Tab; tadalafil 2.5mg once daily; Other Names: Standard First Line Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Investigators: Principal Investigator: Tjahjo Tanojo, dr, Dr. Soetomo General Hospital, Andrology Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 1690/KEPK/XII/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No