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

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058832
• Other study ID #: Shockwave in ED
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Elsayed Abosteit, PhD
• Phone: +201009722931
• Email: sayedabosteit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Erectile dysfunction 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 of sufferers and their partners.

According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction 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 .

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.

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.

Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora.

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.

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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Sexual Dysfunction
• Shock Wave

Intervention

Device:
• Low-intensity Shockwave Therapy
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 plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.

Other:
• Kegel Exercises
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.

Locations

Country	Name	City	State
Egypt	Alhussein Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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

Outcome

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