Clinical trial NCT04219462: Effect of ESWT on ED in Type 2 Diabetics
Official title: Effect of Extracorporeal Shock Wave Therapy (ESWT) on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Diabetes Mellitus, Type 2
Keywords: extracorporal shock wave
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 40 patients assigned to two groups
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients who will have erectile dysfunction ( ED) from 6 months.
3. 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.
4. Body mass index ( BMI) will be \< 30 kg/m²
5. The age of patients will be between 40- 60 years.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the Five-Version of International Index of Erectile function
timeFrame: 6 months after last treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: lecturer of basic sciences- faculty of physical therapy- cairo university
name: Al shymaa s abdelazem, lecturer
role: PRINCIPAL_INVESTIGATOR
References: