Status:
UNKNOWN
DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction
Lead Sponsor:
BioIntegrate
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-80 years
Phase:
PHASE1
PHASE2
Brief 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 Ext...
Detailed 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, v...
Eligibility Criteria
Inclusion
- Only Male patients who are 40 to 80 years old (both numbers inclusive).
- Must have a body mass index (BMI) of less than 35.
- Patients with ED for at least 1 year but less than 10 years.
- The patient is poorly phosphodiesterase type 5 inhibitors responsive, meaning he is able to achieve an erection but is unable or partially able to satisfactory complete sexual intercourse (penetration and/or orgasm).
- Minimum IIEF-EF domain score of 11-16 (for classification as moderate ED).
- IIEF-ED score ≥11 and ≤25 while taking phosphodiesterase type 5 inhibitors or in injection therapy.
- Be willing and capable of giving written informed consent to participate in this clinical study.
- Be willing and capable of complying with study-related requirements, procedures and visits.
Exclusion
- Patients with history of radical prostatectomy or extensive pelvic surgery.
- Patients with past radiation therapy of the pelvic region within 12 months prior to enrollment.
- Patients recovering from cancer within 12 months prior to enrollment.
- Patients who are taking blood thinners or have history of Diabetes Mellitus.
- Patients with untreated hypogonadism or thyroid disease.
- Patients with deformed Penis on physical exam form.
- Patients who participated in another clinical trial or treatment with any investigational product within last 30 days prior to inclusion in the study.
- Patients with serious neurological, psychological or psychiatric disorders which may affect erectile function.
- Patients with other medical conditions determined by site principal investigator as interfering with the study.
- Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04424394
Start Date
January 1 2023
End Date
December 31 2024
Last Update
July 21 2022
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