Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • Erectile Dysfunction
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 40 patients assigned to two groupsMasking: Single (Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 60 years
Gender
Only males

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 re...

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

Tracking Information

NCT #
NCT04219462
Collaborators
Not Provided
Investigators
Principal Investigator: Al shymaa s abdelazem, lecturer lecturer of basic sciences- faculty of physical therapy- cairo university