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Completed

NCT Number: NCT05043896

The Effect of Combination Therapy Using Li-ESWT 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

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Key information

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Li-ESWT

Procedure

Li-ESWT twice weekly for 4 weeks

Other names: Shockwave Therapy

Tadalafil 2.5Mg Tab

Drug

tadalafil 2.5mg once daily

Other names: Standard First Line Therapy

Primary outcomes

  1. Erectile Hardness Score (EHS)

    Time frame: 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

    • 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

  2. International Index of Erectile Function (IIEF-5) score

    Time frame: 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

  3. Peak Systolic Velocity (PSV)

    Time frame: 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

  4. Vascular Endothelial Growth Factor (VEGF) level in plasma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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