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Effect of ESWT on ED in Type 2 Diabetics

NCT04219462 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-07

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Al shymaa s abdelazem, lecturer · lecturer of basic sciences- faculty of physical therapy- cairo university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-07-15
Completion
2020-08-15

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219462 on ClinicalTrials.gov