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

NCT05043896 | Completed

• 1 other identifier: 1690/KEPK/XII/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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 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

  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

Study Arms (2)

Combination therapy

EXPERIMENTAL

Li-ESWT + tadalafil

Procedure: Li-ESWT; Drug: Tadalafil 2.5Mg Tab

Single Therapy

SHAM COMPARATOR

tadalafil only

Drug: Tadalafil 2.5Mg Tab

Interventions

Li-ESWT PROCEDURE

Li-ESWT twice weekly for 4 weeks

Also known as: Shockwave Therapy

Combination therapy

Tadalafil 2.5Mg Tab DRUG

tadalafil 2.5mg once daily

Also known as: Standard First Line Therapy

Combination therapy; Single Therapy

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Only for male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild to Moderate Erectile dysfunction
• Married
• Sexually active
• Consenting to participate in the trial

You may not qualify if:

• Psychological problems
• Spinal injury
• History of malignancy
• Penile anatomy abnormalities
• Allergic and Contraindications to tadalafil
• On anti-mitotic drugs

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead

Study Sites (1)

dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Tjahjo Tanojo, dr

  Dr. Soetomo General Hospital, Andrology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Andrology Department, Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 14, 2021
• Study Start: December 10, 2019
• Primary Completion: June 3, 2020
• Study Completion: June 30, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)