Effect of ESWT on ED in Type 2 Diabetics

NCT04219462 | Unknown

• 1 other identifier: P.T.REC/012/002577
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction; Diabetes Mellitus, Type 2

Keywords

extracorporal shock wave

Outcome Measures

Primary Outcomes (1)

• the Five-Version of International Index of Erectile function

  Each patient will self- administrated the Arabic translated five- Item Version of International Index of Erectile Function (IIEF-5) (in which every patient in both groups will be asked about erectile dysfunction (ED) over their last four weeks). The procedure of IIEF-5 conducted in the following steps: 1. The patient will be asked to answer each item by choosing an answer from the five answers of each five items 2. The number opposite to each answer from the five answers will be determined 3. The final number obtained by the sum of the ordinal responses to the five items. 4. The improvement of erectile dysfunction will be detected according ED severity classification: no ED (score 25-22) mild ED (score 21-17), mild to moderate ED (score 16-12), moderate ED (score 11-8) and severe ED (score 7-1). 5. Measurements will be done before initial session in both groups. Follow up will be after the sixth treatment and at 1, 3, 6 months in both groups.

  6 months after last treatment session

Study Arms (2)

study group

ACTIVE COMPARATOR

twenty 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. 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 +sildenafil 5mg once daily for 3 months.

Device: active extracorporeal shock wave

control group

SHAM COMPARATOR

twenty men will receive sham treatment underwent identical therapy with Extracorporal shock wave therapy (ESWT) application with a similar appearance and sound as the active low intensity 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.

Device: sham extracorporeal shock wave

Interventions

active extracorporeal shock wave DEVICE

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

study group

sham extracorporeal shock wave DEVICE

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.

control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
• Patients who will have erectile dysfunction ( ED) from 6 months.
• Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
• Body mass index ( BMI) will be \< 30 kg/m²
• The age of patients will be between 40- 60 years.

You may not qualify if:

• History of pelvic trauma, pelvic surgery, psychiatric disease.
• Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
• Vascular surgical intervention that recommended for the patients.
• Other renal conditions, respiratory disease, liver failure.
• Prostatectomy and patients with prostatic disease.
• Patients lacking complete follow-up data.
• hypogonadism.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12511, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Al shymaa s abdelazem, lecturer

  lecturer of basic sciences- faculty of physical therapy- cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Al shymaa s abdelazem, lecturer

CONTACT

02 01033771553; shimaashaaban30@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 40 patients assigned to two groups

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 7, 2020
• Study Start: December 2, 2019
• Primary Completion: July 15, 2020
• Study Completion: August 15, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

EG (1)