Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients. To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients. To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.

Detailed Description
-----------------
Erectile dysfunction (ED) is defined as the persistent inability to attain and maintain an erection enough to permit satisfactory sexual performance. Although ED is a benign disorder, it may affect physical and psychosocial health and may have a significant impact on the quality of life (QoL) of sufferers and their partners (Ruffo et al., 2015). According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction (ED) is defined as an inability to get or keep an erection firm enough for sexual intercourse due to diseases such as diabetes mellitus and atherosclerotic vascular occlusive disease (Stief et al., 2010). ED has been reported to occur in ≥50% of men with DM worldwide. It is usually present within 10 years of diagnosis of DM. The incidence of ED was reported to be higher in men with DM than for men without DM and up to 12% of men who present with ED were found to have previously undiagnosed DM (Johannes et al., 2000). Low-intensity extracorporeal shock wave therapy (Li-ESWT) was used in both in vitro and in vivo studies and the results showed that this energy can stimulate angiogenesis. The idea of applying Li-ESWT to the penis came from animal studies in which Li-ESWT was applied to the myocardium of pigs, where it has been reported that there was an improvement in ischemia-induced myocardial dysfunction (Nishida et al., 2004). Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora (Gruenwald et al., 2013). Oral phosphodiesterase-5 inhibitors (PDE-5 inhibitors), such as sildenafil and tadalafil, are usually the first-line treatment of erectile dysfunction. They are effective in a wide range of etiologies including cardiovascular disease, diabetes, and hypogonadism (Muneer et al., 2014) Contraction of the ischiocavernosus participates in the process of enhancing erectile rigidity by compressing the roots of the corpora cavernosa and inducing short-term suprasystolic intracavernosal pressures ((Cohen et al., 2016). Further, bulbospongiosus contraction leads to temporary engorgement of the glans penis and corpus spongiosum and results in similar short-term increases in intra spongiosal pressures (Siegel et al., 2014).

Official Title
-----------------
Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients

Conditions
-----------------
Shock Wave, Sexual Dysfunction

Intervention / Treatment
-----------------
* Device: Low-intensity Shockwave Therapy
* Other: Kegel Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction due to Type 2 diabetes for at least six months . Age between 35-55 years. Exclusion Criteria: - 1. Venogenic ED 2. Poly neuropathy 3. Past radical prostatectomy or extensive pelvic surgery 4. Recovering from cancer in the past 5 years 5. Any unstable medical and psychiatric disorder. 6. Spinal cord injury and another neurological disease 7. Penile anatomical abnormalities. 8. Clinically significant chronic hematological disease. 9. Anti-androgens or radiotherapy treatment of pelvic region. 10. Patients with untreated hypogonadism. 11. Psychogenic ED (normal nocturnal penile tumescence parameters) 12. Cardiovascular conditions that prevent sexual activity (heart attack, stroke, or life-threatening arrhythmia within the previous 6 months. 13. Patient with penile prosthesis

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-intensity Shockwave Therapy<br> | Device: Low-intensity Shockwave Therapy<br>* patients will receive 6 sessions, once per week - of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level (Shendy et al, 2021) plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.<br>|
| Experimental: Kegel Exercises<br> | Other: Kegel Exercises<br>* The training program consists of active exercises. Each patient will be taught how to contract the pelvic-floor muscles. He will be asked to mimic holding in the flow of urine and to contract the target muscles as hard as possible. The exercises will be done in a supine position with the knees flexed because it is easier to feel the pelvic-floor muscles in this position. The patient will be asked to perform short (1 second) and long-lasting (6-10 seconds) contractions of the target muscles. Later, the exercises will be done with the patient sitting or standing. Patient will be asked to repeat the contractions daily. Each patient will be performed 40 short and 50 long-lasting contractions in a prone, sitting, or standing position. Patients will be asked to do 30 contractions in the morning, 30 contractions in the afternoon, and 30 contractions in the evening.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile color-coded Duplex scanning | for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention. | baseline | 
| International Index of Erectile Function (IIEF-EF) questionnaire | At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25) | baseline |