Possible Solution when meds aren't working

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Hi everyone. I am working on a clinical trial of a minimally invasive procedure that has been shown to have excellent effects on urgency urinary incontinence in both men and women. It is a fully funded study-we don't bill insurance or you. You are compensated for your time as well. I am in the Columbus, OH area but we have about 15 study sites across the nation-just let me know what city you are in. Please call or email me if you want more details. 614-705-8971. Veronica.wandrey@gmail.com. I am here to help!
Take care,
Veronica
 
Absolutely.

The participant will be screened and then randomized to either our device which is a stimulator that is placed in the ankle (minimally invasive 1cm incision) or the InterStim stimulator which is placed by the sacral nerve (low back). You will have follow up appointments to check your progress at 1, 3, 6, 9 and 12 months...all the while I am checking in with you to offer support and answer questions. If you'd like to take a look at our website please visit: MicronMed.com. There is a quick survey on the website you can take to see if you meet the initial eligibility requirements. I review those surveys and call the prospective candidate within 24 hrs to discuss further..Or you can call my cell phone.

Thank you!

Veronica
614-705-8971
 
Can you provide more information about who you and your company are and what the trial is? The only Veronica Wandrey I can google for your area works in eldercare? Look im always curious of any new information or ideas but would like to be sure who or what is offering it please.
 
Hi! Yes. I work for Micron Medical Corporation (Mirconmed.com) Corporate office is in BOCA RATON FL. We have study sites in Columbus, OH, three sites in California, New York, Miami and Tampa Florida, Chicago, Royal Oak, MI, St. Louis MO, Omaha NB, Dallas TX, etc.

I am a Clinical Specialist...been with the company for about 10 months. I worked at Methodist Eldercare for about 4 years prior to that. Feel free to check out my LinkedIn and the Micron Med LinkedIn and FaceBook page as well.

The trial is called the PROTECT Study. You can find more info about the device and how it works on Micronmed.com

Veronica Wandrey
614-705-8971
veronica@micronmed.com
 
Aside from medications and botox there are other treatment options available that people should know about. Thank you for your comment!
 
The device is FDA approved to treat other issues...we've found that it may also be affective in treating urge OAB. Any questions please feel free to contact me!

Thank you!
 
JSSSSCC said:
This is surgery and the implant isn't FDA approved. This is a patient site...not a marketing site.

it's a clinical trial..by definition wouldn't be FDA approved...clinical trials are part of the FDA approval process. Sharing links/info here for clinical trials is not marketing.
 
findasolution1234 said:
Aside from medications and botox there are other treatment options available that people should know about. Thank you for your comment!

Sounds like Tibial Nerve Stimulation....how is it different? Or are you just trying to get approval for a new brand of TNS machine?
 
Thank you, Mike. Yes-tibial nerve stimulation.
The InterStim stimulates the Sacral Nerve. Our device stimulates the tibial nerve.

It's different from PTNS in that you do your therapy wherever you are. The stimulator is implanted in the ankle next to the tibial nerve and you wear an external device (that activates your stimulator)around the ankle for a few hours as you go about your day. You don't have to go into the MD office once a week for 12 weeks for a half hour to receive stimulation (and then on-going treatments for it to remain effective)

We are seeking FDA approval for the the efficacy of our device...goal is 50% or more reduction in urge OAB symptoms.
 
I've been in a clinical study years ago, but introduced to the idea in hospital (cancer).
My understanding and experience is there are extensive documents, much of which are highly technical, detailing the proposed clinical trial, procedures, any studies or evidence that led to thinking a clinical trial was worth while, etc. I asked for some explanations. There was a nurse assigned for that purposes for all the members of the group (we never met as a group). It was much more invasive, chemotherapy (including an experimental drug) incl. both oral and IV meds, surgery, etc. so the precautions & cautions were extensive. I think they put me through every test known to man or beast, both before & after. A few years after, I thought to look up the study, found the journal article - and the references made by others since. Obviously, this isn't at that level.
I'm not opposed to this, or its appearance here, just giving us another look at how we might be able to evaluate it all.
Is it a double-blind study, somehow?
I'd look at the cautions & caveats. I did do the clinical trial, & by the numbers. I'm alive now when the odds weren't necessarily good. Remember, I'm one of many, so who knows exactly why I was one of the ones "cured". It became an approved treatment, then. (probably there is better, now).
It was like this proposed study. Of course the drug company wanted to make a profit if the drug worked out. The only complaint I might have is the CEO of the drug company shouldn't be making $320 million dollars a year when the secretary is barely getting by.
Anyway, 50% would be great. Certainly better than anything I've heard of yet.
Good luck, do your due-diligence, and God Bless.
 
@AlasSouth Thank you for sharing your story and allowing me to share this information with the group. There is an informed consent and some things to look over. The Research Coordinator at the study site will go over everything with the individual and answer any questions. It's a randomization. The Physician draws an envelope and opens it with the patient to reveal if they were randomized to the PNS arm or the SNS arm.

I agree with you ❤️ Take care :)
 
findasolution1234 said:
Thank you, Mike. Yes-tibial nerve stimulation.
The InterStim stimulates the Sacral Nerve. Our device stimulates the tibial nerve.

It's different from PTNS in that you do your therapy wherever you are. The stimulator is implanted in the ankle next to the tibial nerve and you wear an external device (that activates your stimulator)around the ankle for a few hours as you go about your day. You don't have to go into the MD office once a week for 12 weeks for a half hour to receive stimulation (and then on-going treatments for it to remain effective)

We are seeking FDA approval for the the efficacy of our device...goal is 50% or more reduction in urge OAB symptoms.

interesting...I'm considering PTNS as my very last ditch attempt to solve this before just accepting diapers for the rest of my life. PTNS is a multi visit thing and then you're done, supposedly....With your device, how long does this implant stay in?
 
MikeJames said:
findasolution1234 said:
Thank you, Mike. Yes-tibial nerve stimulation.
The InterStim stimulates the Sacral Nerve. Our device stimulates the tibial nerve.

It's different from PTNS in that you do your therapy wherever you are. The stimulator is implanted in the ankle next to the tibial nerve and you wear an external device (that activates your stimulator)around the ankle for a few hours as you go about your day. You don't have to go into the MD office once a week for 12 weeks for a half hour to receive stimulation (and then on-going treatments for it to remain effective)

We are seeking FDA approval for the the efficacy of our device...goal is 50% or more reduction in urge OAB symptoms.

interesting...I'm considering PTNS as my very last ditch attempt to solve this before just accepting diapers for the rest of my life. PTNS is a multi visit thing and then you're done, supposedly....With your device, how long does this implant stay in?
 
@MikeJames Hello! The implant is in for life! You'll stimulate from the comfort of your home (or wherever) a few hours a day.
 
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