NCT04219462

Effect of ESWT on ED in Type 2 Diabetics

Effect of Extracorporeal Shock Wave Therapy (ESWT) on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED

Detailed description

ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups: Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg

Conditions

• Erectile Dysfunction
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	active extracorporeal shock wave	Ultrasound gel was used as a coupling agent, and the applicator of extracorpral shock wave therapy (ESWT) will be held perpendicular to the treatment surface throughout the treatment. Men in this group (n= 20) men receive ESWT twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura + 5 mg sildnafil once daily for 3 months
DEVICE	sham extracorporeal shock wave	twenty men will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months.

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-07-15
• Completion: 2020-08-15
• First posted: 2020-01-07
• Last updated: 2020-01-07

Locations

1 site across 1 country: Egypt