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

Sponsor
Dr. Soetomo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05043896
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Li-ESWT
  • Drug: Tadalafil 2.5Mg Tab
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Actual Study Start Date :
Dec 10, 2019
Actual Primary Completion Date :
Jun 3, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 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 [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) [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 dr. Soetomo General Hospital Surabaya Jawa Timur Indonesia 60286

    Sponsors and Collaborators

    • Dr. Soetomo General Hospital

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrian, dr., Sp.And, Resident of Andrology Department, Principal Investigator, Medical Doctor, Dr. Soetomo General Hospital
    ClinicalTrials.gov Identifier:
    NCT05043896
    Other Study ID Numbers:
    • 1690/KEPK/XII/2019
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Tadalafil

    Study Results

    No Results Posted as of Sep 14, 2021