Erectile DysfunctionPhase 1/2NCT04424394
DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction
A Phase 1/2 study testing DualStim Therapy, Umbilical cord-derived Wharton's Jelly and Saline in people with Erectile Dysfunction, run by BioIntegrate.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- DualStim Therapy, Umbilical cord-derived Wharton's Jelly and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
Ashim Gupta, PhD, MBA contact
About this study
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
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).
Read the 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).
- Conditions
- Erectile Dysfunction
- Being tested
- DualStim Therapy, Umbilical cord-derived Wharton's Jelly, Saline
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DualStim TherapyDevice
6 DualStim Therapies over a period of 7 weeks.
Umbilical cord-derived Wharton's JellyBiological
2 intracavernosal injections over a period of 7 weeks.
SalineOther
2 intracavernosal injections over a period of 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DualStim Therapy with Wharton's Jelly Injection | Experimental | DualStim therapy with intracavernosal injection of umbilical cord-derived Wharton's Jelly formulation. Receives: Device: DualStim Therapy; Biological: Umbilical cord-derived Wharton's Jelly |
| DualStim Therapy without Wharton's Jelly Injection | Active comparator | DualStim therapy with intracavernosal injection of normal saline. Receives: Device: DualStim Therapy; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: During the procedure
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: 1 month follow-up visit
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: 3 month follow-up visit
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: 6 month follow-up visit
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: 12 month follow-up visit
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.
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.
Measured: 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
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.
Measured: through study completion, an average of 18 months
Secondary outcomes (4)
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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioIntegrate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Gaines, MD, Principal investigator, LifeGAINES Medical and Aesthetics CenterAshim Gupta, PhD, MBA, Study director, BioIntegrate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424394
- Sponsor's protocol ID
- BIOINT - 2020DSWJ/ED
- Status last verified
- Jul 2022
- First submitted
- 4 Jun 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424394
- Acronym / sponsor ID
- BIOINT - 2020DSWJ/ED
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioIntegrateIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DualStim Therapy with Wharton's Jelly Injection | Experimental | Device: DualStim Therapy, Biological: Umbilical cord-derived Wharton's JellyDualStim therapy with intracavernosal injection of umbilical cord-derived Wharton's Jelly formulation. |
| DualStim Therapy without Wharton's Jelly Injection | Active comparator | Device: DualStim Therapy, Other: SalineDualStim therapy with intracavernosal injection of normal saline. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DualStim Therapy6 DualStim Therapies over a period of 7 weeks. | Device | DualStim Therapy with Wharton's Jelly Injection, DualStim Therapy without Wharton's Jelly Injection |
| Umbilical cord-derived Wharton's Jelly2 intracavernosal injections over a period of 7 weeks. | Biological | DualStim Therapy with Wharton's Jelly Injection |
| Saline2 intracavernosal injections over a period of 7 weeks. | Other | DualStim Therapy without Wharton's Jelly Injection |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashim Gupta, PhD, MBA contact
Richard Gaines, MD principal investigator
LifeGAINES Medical and Aesthetics Center
Ashim Gupta, PhD, MBA study director
BioIntegrate
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DualStim Therapy, Umbilical cord-derived Wharton's Jelly and Saline in people with Erectile Dysfunction, run by BioIntegrate.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Gaines, MD (561-931-2430, rg3090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection. (time frame: During the procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.