DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title: A Pilot Study to Evaluate the Immediate and Short-term Efficacy of DualStim (Focused and Radial Extracorporeal Shock Wave) Therapy With and Without Intracavernosal Wharton's Jelly in Patients With Erectile Dysfunction

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to determine the immediate and short-term efficacy of the methodological application of DualStim Therapy - Focused Extracorporeal Shock Wave Therapy (fESWT) and Radial Extracorporeal Shock Wave Therapy (rESWT), with and without intracavernosal administration of formulated umbilical cord derived Wharton's Jelly to improve and/or restore erectile function in patients with erectile dysfunction (ED).

Clinical Trial Description

Erectile Dysfunction (ED) is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, vacuum devices, intracavernosal injections, and surgically placed penile prosthetics. In the literature, this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.

The low intensity extracorporeal shock wave therapy (LISWT) was recently approved by the FDA for treatment of diabetic ulcers. But it is still under evaluation for treatment of ED. Recently, the European Association of Urology updated their guidelines related to ED and included LISWT for men with mild to moderate ED. Studies have reported that LISWT can be effective in treating ED. This was attributed to increase in angiogenesis, neurogenesis and other rejuvenating tissue effects. Doppler ultrasound studies have demonstrated a sustained increase in blood flow in patients treated with LISWT. Published studies have also reported a response rate of 40-80% with this treatment. In addition, the energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; and no serious side effects have been reported till date.

Additionally, most completed studies included men who score in the moderate to minimal ranges on the International Index of Erectile Function. In the proposed study, men with severe to moderate ED based on IIEF-EF score will be included. The goal of this study is to improve and/or restore erectile function in men with erectile dysfunction. The investigators hypothesize (Alternate Hypothesis) that patients in the active treatment group (DualStim + Wharton's Jelly) will show an improvement of at least 4 points for moderate ED and at least 7 points for severe ED on IIEF-EF scale/questionnaire, and this difference will be significantly different from their baseline. In addition, patients in the DualStim + Saline group will be significantly different from their baseline, however, will show less improvement compared to DualStim + Wharton's Jelly. Our null hypothesis is that there is no difference between DualStim with Saline and DualStim with Wharton's Jelly groups and no difference between the baseline and after-treatment within the treatment groups for alleviating ED measured using International Index of Erectile Function score (IIEF-EF). ;

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT04424394
• Study type: Interventional
• Source: BioIntegrate
• Contact: Richard Gaines, MD
• Phone: 561-931-2430
• Email: rg3090@gmail.com
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2023
• Completion date: December 31, 2024