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
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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
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
NCT ID
NCT05043896
First Posted
August 26, 2021
Last Updated
September 9, 2021
Sponsor
Dr. Soetomo General Hospital
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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