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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Li-ESWT
Tadalafil 2.5Mg Tab
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • dr. Soetomo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Combination therapy

Single Therapy

Arm Description

Li-ESWT + tadalafil

tadalafil only

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2021
Last Updated
September 9, 2021
Sponsor
Dr. Soetomo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05043896
Brief Title
The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Official Title
The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soetomo General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
Li-ESWT + tadalafil
Arm Title
Single Therapy
Arm Type
Sham Comparator
Arm Description
tadalafil only
Intervention Type
Procedure
Intervention Name(s)
Li-ESWT
Other Intervention Name(s)
Shockwave Therapy
Intervention Description
Li-ESWT twice weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tadalafil 2.5Mg Tab
Other Intervention Name(s)
Standard First Line Therapy
Intervention Description
tadalafil 2.5mg once daily
Primary Outcome Measure Information:
Title
Erectile Hardness Score (EHS)
Description
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
Time Frame
4 weeks
Title
International Index of Erectile Function (IIEF-5) score
Description
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
Time Frame
4 weeks
Title
Peak Systolic Velocity (PSV)
Description
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
Time Frame
4 weeks
Title
Vascular Endothelial Growth Factor (VEGF) level in plasma
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only for male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjahjo Tanojo, dr
Organizational Affiliation
Dr. Soetomo General Hospital, Andrology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr. Soetomo General Hospital
City
Surabaya
State/Province
Jawa Timur
ZIP/Postal Code
60286
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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