Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction

Study Overview
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Brief Summary
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The goal of this trial is that using tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) is more effective than using tadalafil alone in improving erection rigidity and sexual function. The efficacy of the combination of li-ESWT and tadalafil has been confirmed by a number of studies, including in patients after radical prostatectomy. However, this method is still not a first-line method in young primary patients and its benefits in combination with drugs for these patients are not obvious. The investigators assume that the combination of tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) will improve the subjective state of patients assessed by points of validated questionnaires and Number of successful intercourse per week.

Detailed Description
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The aim of the study is to test the hypothesis that using tadalafil plus shockwave in primary patient with ED treatment in more effective in improving erection rigidity and sexual function, then using tadalafil alone.

Official Title
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Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT
* Drug: PDE5 inhibitor (tadalafil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Age 20 to 45; Married or have had a permanent sex partner for at least 3 months; IIEF-5 questionnaire scores below 20 Exclusion Criteria: History of previous use of PDE-5 inhibitors or fSWT; Patients with diabetes mellitus; Patients after the radical prostatectomy or major pelvic surgery; Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury); Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medication group<br>PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month | Drug: PDE5 inhibitor (tadalafil)<br>* Tadalafil improves erectile function by inhibiting PDE5 isoenzyme, thereby blocking cGMP degradation. As a result, the PDE5 inhibitors act synergistically with NO to markedly increase the levels of cGMP, which in the presence of sexual stimulation, lead to an erection. In the absence of sexual stimulation, NO is not released locally and the PDE5 inhibitors do not affect the penis. Thus, sexual stimulation is needed to initiate the erectile mechanism for the PDE5 inhibitors to take effect.<br>|
| Experimental: Combination group<br>PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month plus Device BTL-6000 fSWT: 6 sessions with EFD 0,09 mJ/mm2 by 5000 impulses per session in 5 points in corpora cavernosa penis | Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT<br>* The mechanism of low-intensity shockwave therapy in patients with ED based on the effect on the endothelium of the cavernous arteries, the release of NO and the enhancement of vascularization due to release of angiogenic factors.<br>Drug: PDE5 inhibitor (tadalafil)<br>* Tadalafil improves erectile function by inhibiting PDE5 isoenzyme, thereby blocking cGMP degradation. As a result, the PDE5 inhibitors act synergistically with NO to markedly increase the levels of cGMP, which in the presence of sexual stimulation, lead to an erection. In the absence of sexual stimulation, NO is not released locally and the PDE5 inhibitors do not affect the penis. Thus, sexual stimulation is needed to initiate the erectile mechanism for the PDE5 inhibitors to take effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-5 | IIEF-5 (International Index of Erectile Function-5) is validated erectile function assessment questionnaire. The possible scores for the IIEF-5 range from 5 to 25, with lower values representing poorer sexual function. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGI-I | The Patient Global Imression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy. This is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1-Very much better to 7-Very much worse. | 14 days,30 days, 60days. | 
| Likert scale (7-point preferably) satisfaction questionnaire | Likert Scale questions offer a range of answer options from either end of the spectrum for the respondents to choose from, where 1-extremely dissatisfied, 7- extremely satisfied | 14 days,30 days, 60days. | 
| Therapy comfort survey | Modified scale indicating how comfort patients feel about therapy, where 1is totally uncomfortable, and 7 is very comfortable. | 14 days,30 days, 60days. | 
| Number of successful intercourse per week | Number of successful intercourse per week | 14 days,30 days, 60days. |