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

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

Detailed Description
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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

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Procedure: Li-ESWT
* Drug: Tadalafil 2.5Mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination therapy<br>Li-ESWT + tadalafil | Procedure: Li-ESWT<br>* Li-ESWT twice weekly for 4 weeks<br>* Other names: Shockwave Therapy;Drug: Tadalafil 2.5Mg Tab<br>* tadalafil 2.5mg once daily<br>* Other names: Standard First Line Therapy;|
| Sham Comparator: Single Therapy<br>tadalafil only | Drug: Tadalafil 2.5Mg Tab<br>* tadalafil 2.5mg once daily<br>* Other names: Standard First Line Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |