Sexual Dysfunction Clinical Trial
Official title:
Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
- 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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 55 Years |
Eligibility | Inclusion Criteria: - Arteriogenic erectile dysfunction due to Type 2 diabetes for at least six months. - Age between 35-55 years. Exclusion Criteria: - Venogenic ED. - Poly neuropathy. - Past radical prostatectomy or extensive pelvic surgery. - Recovering from cancer in the past 5 years. - Any unstable medical and psychiatric disorder. - Spinal cord injury and another neurological disease. - Penile anatomical abnormalities. - Clinically significant chronic hematological disease. - Anti-androgens or radiotherapy treatment of pelvic region. - Patients with untreated hypogonadism. - Psychogenic ED (normal nocturnal penile tumescence parameters) - Cardiovascular conditions that prevent sexual activity (heart attack, stroke, or life-threatening arrhythmia within the previous 6 months. - Patient with penile prosthesis. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alhussein Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Cohen D, Gonzalez J, Goldstein I. The Role of Pelvic Floor Muscles in Male Sexual Dysfunction and Pelvic Pain. Sex Med Rev. 2016 Jan;4(1):53-62. doi: 10.1016/j.sxmr.2015.10.001. Epub 2016 Jan 8. — View Citation
Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25. — View Citation
Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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