Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in DM Patients

NCT06058832 | Completed

• 1 other identifier: Shockwave in ED
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

• To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients.
• To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
• To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.

Conditions

Sexual Dysfunction; Shock Wave

Outcome Measures

Primary Outcomes (2)

• Penile color-coded Duplex scanning

  for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.

  baseline

• International Index of Erectile Function (IIEF-EF) questionnaire

  At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)

  baseline

Study Arms (3)

Low-intensity Shockwave Therapy

EXPERIMENTAL

patients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.

Device: Low-intensity Shockwave Therapy

Kegel Exercises

EXPERIMENTAL

kegel exercises plus sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.

Other: Kegel Exercises

control group

NO INTERVENTION

Interventions

Low-intensity Shockwave Therapy DEVICE

patients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.

Low-intensity Shockwave Therapy

Kegel Exercises OTHER

* The patient was asked to perform short (1 second) and long-lasting (6-10 seconds) contractions of the target muscles. Later, the exercises will do with the patient sitting or standing. * Patient asked to repeat the contractions daily. Each patient performed 15 short and 15 long-lasting contractions in a prone, sitting, or standing position. Patients asked to do 30 contractions in the morning 30 contractions in the evening

Kegel Exercises

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ninety married men were diagnosed with T2DM participated in this study.
• The patients complained from arteriogenic ED \> 6 months (Reisman et al., 2015) before the participation in this study
• All patients aged between 35-55 years old.
• Glycated hemoglobin (HbA1c) less than 9%.
• Body mass index of the patients was \< 30 Kg/m2.

You may not qualify if:

• Alcohol-abuse, illegal drug consumer patients.
• Patients with cardiac diseases that prevent or affect sexual activity (heart attack, stroke, heart failure, myocardial infarction life-threatening, arrhythmia, etc within the previous 6 months).
• Patients with any pulmonary, liver, or kidney diseases.
• Patients with neurological insults, spinal cord injuries, stroke, polyneuropathy, etc.
• Patients with diagnosed psychiatric/mental complaints.
• Patients with blood pressure of more than 140/90 mmHg.
• Patients with peripheral vascular disease.
• Patients with venogenic ED.
• Patients with past radical prostatectomy, extensive pelvic surgery, or previous pelvic trauma.
• Patients recovering from cancer in the past 5 years
• Penile anatomical abnormalities.
• Patients with clinically significant chronic hematological disease.
• Patients who received Anti-androgens or radiotherapy treatment of pelvic region.
• Patients with untreated hypogonadism.
• Patients with psychogenic ED (normal nocturnal penile tumescence parameters)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alhussein Hospital

Cairo, 3753450, Egypt

Location

Related Publications (3)

• Cohen D, Gonzalez J, Goldstein I. The Role of Pelvic Floor Muscles in Male Sexual Dysfunction and Pelvic Pain. Sex Med Rev. 2016 Jan;4(1):53-62. doi: 10.1016/j.sxmr.2015.10.001. Epub 2016 Jan 8.

  PMID: 27872005 BACKGROUND

• Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25.

  PMID: 15527607 BACKGROUND

• Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.

  PMID: 27784587 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Elsayed Abosteit, PhD

  physical therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: January 5, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 6, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

EG (1)