- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424394
DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction
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
Study Overview
Status
Conditions
Intervention / Treatment
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, 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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Ashim Gupta, PhD, MBA
- Email: agupta@biointegrate.com
Study Contact Backup
- Name: Richard Gaines, MD
- Phone Number: 561-931-2430
- Email: rg3090@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DualStim Therapy with Wharton's Jelly Injection
DualStim therapy with intracavernosal injection of umbilical cord-derived Wharton's Jelly formulation.
|
6 DualStim Therapies over a period of 7 weeks.
2 intracavernosal injections over a period of 7 weeks.
|
Active Comparator: DualStim Therapy without Wharton's Jelly Injection
DualStim therapy with intracavernosal injection of normal saline.
|
6 DualStim Therapies over a period of 7 weeks.
2 intracavernosal injections over a period of 7 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: During the procedure
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
During the procedure
|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: 1 month follow-up visit
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
1 month follow-up visit
|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: 3 month follow-up visit
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
3 month follow-up visit
|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: 6 month follow-up visit
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
6 month follow-up visit
|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: 12 month follow-up visit
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
12 month follow-up visit
|
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Time Frame: 18 month follow-up visit
|
To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
Any adverse or severe adverse events will be recorded in the associated case report forms.
|
18 month follow-up visit
|
Immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly based on changes in the International Index of Erectile Function Questionnaire score compared to baseline
Time Frame: through study completion, an average of 18 months
|
To evaluate the immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly based on changes in the International Index of Erectile Function Questionnaire score compared to baseline score.
An increase in the score indicates improvement.
|
through study completion, an average of 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly compared to DualStim Therapy with saline based on changes in the International Index of Erectile Function Questionnaire score.
Time Frame: through study completion, an average of 18 months
|
To evaluate the immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly compared to DualStim Therapy with saline based on changes in the International Index of Erectile Function Questionnaire score at each time-point.
|
through study completion, an average of 18 months
|
Sexual activity improvement according to Sexual Encounter Profile Questionnaire from baseline leading to optimal penetration at follow-ups
Time Frame: through study completion, an average of 18 months
|
To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Sexual Encounter Profile Questionnaire.
An increase in score indicates improvement.
|
through study completion, an average of 18 months
|
Sexual activity improvement according to Global Assessment Questionnaire from baseline leading to optimal penetration at follow-ups
Time Frame: through study completion, an average of 18 months
|
To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Global Assessment Questionnaire.
An increase in score indicates improvement.
|
through study completion, an average of 18 months
|
Sexual activity improvement according to Erection Hardness Score from baseline leading to optimal penetration at follow-ups
Time Frame: through study completion, an average of 18 months
|
To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Erection Hardness Score.
An increase in score indicates improvement.
|
through study completion, an average of 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ashim Gupta, PhD, MBA, BioIntegrate
- Principal Investigator: Richard Gaines, MD, LifeGAINES Medical and Aesthetics Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOINT - 2020DSWJ/ED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionCzech Republic, Lithuania, Netherlands, Palestinian Territories, Occupied
-
Rexahn Pharmaceuticals, Inc.CompletedErectile Dysfunction (ED)United States
-
SK Chemicals Co., Ltd.TerminatedMale Erectile Dysfunction
Clinical Trials on DualStim Therapy
-
University of Alabama at BirminghamCompleted
-
Mennallah Ahmed Mohamed Anwar ElgendyNot yet recruiting
-
Spaulding Rehabilitation HospitalActive, not recruiting
-
Istanbul Medipol University HospitalCompleted
-
St. Jude Children's Research HospitalCompletedStem Cell Transplant | Bone MarrowUnited States, Canada
-
Universidad de ZaragozaCompletedPlagiocephaly | Plagiocephaly, Nonsynostotic | Plagiocephaly, PositionalSpain
-
National Taiwan University HospitalNot yet recruitingAutism | Language Delay | Speech Disorders in Children
-
Riphah International UniversityCompleted
-
Hospital for Special Surgery, New YorkActive, not recruiting