New BPH treatment clinical trial Part 1: Prostate Stent
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- Опубліковано 20 січ 2023
- Information about a clinical trial for the enlarged prostate evaluating the newest BPH treatment options. These are minimally-invasive prostate stents that can be placed improve urinary symptoms, and unlike some current treatments, are removable, if necessary. The goal of treatment is to use these devices to open the prostatic urethra without damage to urinate better and not affect sexual function or urinary control. Participation is the study is free of cost, and more information about participation is discussed.
More information by emailing BPHtrial@HoustonMethodist.org
@RRGonzalezUrology
#Zenflow #ButterflyMedical #Proverum #Provee #Prodeon #Urocross #Urolift #iTIND #Rezum #Urology #menshealth #prostate #BPH #clinicaltrials - Наука та технологія
STENTS are used in opening up the narrowing blood vessels with a great success. I'm glad that finally are going to be successfully used in BPH cases.
Crazy! I work in aerospace and have used Nitinol in aerospace applications for its shape memory properties.
I’m surprised something like this hasn’t been tried before? or has it ? Seems like a pretty obvious solution if it works 👍🏻
Prior attempts have failed because of design/material issues. Old designs were woven and not designed to be removed if needed.
@@RRGonzalezUrologydoes this process disrupt sexual functions or do you just resume natural sexual functionality? Also what is the recovery time? And if the prostrate continues to enlarge how is the stint affected?
@@sparkspark2314i wonder the same👍 Old type were for people that would die soon🙄
@@lunacallie6858why would they die soon
Good luck with trials. This sounds like a eureka idea!. At this moment I'm with catheter waiting to see urologist May 3. South Africa you tube.
August 23 went in for PAE at Sunninghill with Dr Cornish . 95g . It’s a lot tougher to recover with catheter.
I am in the USA. Every doctor's appointment is weeks or months in the future. Imagine having a catheter in that long? What a PITA, or PITP. @@neviozivkovic4545
This would seemingly be the least invasive thing to do for BPH and stents are commonly used in arteries to open blockages. I would just wonder about the body rejecting it and how effective it would be over time as the prostate continues to press on it.
Is it true that urine (uric acid) could react with the stent material causing the build up of plaque that could block the flow? That is the excuse few doctors gave me.
Interesting! Ever since you uploaded the video so far what have your interventions show?
This is an FDA IDE trial. Findings will be reported when the study is complete!
@@RRGonzalezUrology When?
I recently heard about a waterjet method of removing excessive prostate tissue. I am more likely to opt for something like that than a stent. Before allowing any type of procedure, I'm going to try a combination of a pumpkin seed diet combined with daily beta sitosterol supplementation.
meto but am scheduled for rezum soon
Aquablation is robotic water jet ablation. It is done in the operating room but has advantages in maximum preservation of sexual health.
Ja fiz esse regime sementes de abobora,etc,e jatos de agua,a unica soluçâo è introduzirem o stent.
I have tried every supplement you can possibly think of. A stent seems to me to be the least invasive. All proceedures require a catheter be put back in for a week or two. No catheter with stent proceedure.
I've wondered for sometime why a stent is not used to relieve symptoms.
I wondered also when I started looking at proceedures. Like you, I wondered why they couldn't just put a stent in, just like heart stents. I have found that they do! iTind. But I am having a hard time finding a doctor that performs this proceedure..
Great thanks for newly invented stent treatment of BPH. Has it reached India. Please inform me, because I am aged 70 having BPH problem with 33 gms of prostate. Is Stent treatment successful?
We are currently doing trials to evaluate effectiveness and durability.
As a medical student, I believe minimally invasive (non-necrotizing and non-resecting) procedures are indeed the way of the future, but I wonder what are the risks of infections associated with this implanting, as even prosthetic heart valve implants are subject to vegetation and it sits in a much more sterile environment.
Could you give an example of the non-invasive procedure?
@@secondthoughtsecondthought3187 Sorry my friend, I meant minimally invasive, as the stent, in this case. Certainly there is no procedure that is 100% non-invasive.
With micopolishing, the materials are low risk of encrustation and safety data is collected during the trial
I would ‘think’ that an answer to your question may already be available from statistics gathered from stents used in people with kidney stones
@@dominicm2175 those stents for stones need to be removed as otherwise have high risk of encrustation. It is different and we are investigating the effectiveness and safety.
I doubt that as long as you continue to not hold out going to the bathroom but always go when you have the urge, BPH will not damage your kidneys. Patients should not delay urinating.
Are there any medical facilities in Florida participating in the trial? Preferably around the Panama City Florida area.
You can check on clinicaltrials.gov and search "LUTS" (lower urinary tract symtpoms) and enter your city to see what trials are near you.
RRG
This website is useless. Harder to navigate than the IRS tax code.
Filters ignore the given location. @@RRGonzalezUrology
When will the clinical trial be completed? Recently ran across your video. I've had a failed UroLift. If the device is approved, would it be an option for me? In other words, are there any limitations or conditions which would prevent someone from receiving the procedure/ treatment?
Enrollment is active and five year results will be collected. Outside of the trial, it is years away from commercial use.
@@RRGonzalezUrology Thanks for the reply. I'm assuming the stent's inner diameter is large enough for a catheter to fit thru, correct? In cases where a catheter may be required.
Does the patient Feel the implant? If so, is it a temporary condition? Do you feel like you have to go to the bathroom all the time? If so, is it a temporary condition? I don't feel my Urolift implants, however, I felt like I needed to go all the time after the procedure. 18 months post op, the feeling crops up on occasion.
I'm looking at itind, PAE and Stent(yours) due to limited sexual side affects, limited bleeding and urethral inflammation. I have a st jude aortic valve requiring daily coumadin. Thanks
@@user-eg1sw7kd6gi hear PAE doesn’t last, so im looking at a new one that used cold water 👍👍
If you are experiencing symptoms such as nocturia and frequent urination, despite having a medium-sized prostate, would you be willing to consider trying this?
Depends if you qualify for the trial by functional and anatomic testing.
hi, those were my exact symptoms, also having medium-enlarged prostate. But a cystoscopy revealed my issue being a large medium-lobe of the prostate which seems to affect about 10% of us. Have you had this camera-scope procedure yet?
Does this stent affect the muscles that control the flow ( i.e cause incontinenece)
No it does not. It does not traverse the sphincter.
@@RRGonzalezUrology I would voluteer if you were working in Australia. I belive this is a other worthwhile non invasive option for us all to consider. From what i understand this along with Rezum or Urolift would be the only non invasive treatment options that does not give long term side affects of possible incontinence
I would not only be happy to participate in these trials, I would pay you to install this stent in me.
Is anyone doing it in North Carolina, USA?
Wish I could have participated. I'm not within the required 50 mile required radius.
You can check on clinicaltrials.gov and search "LUTS" (lower urinary tract symtpoms) and enter your city to see what trials are near you.
RRG
Do patients have to come to Houston for the trial?
Houston Methodist is a site, but there may be others near you. Trials include BREEZE (Zenflo), Prodeon Medical, Butterfly Medical and ProVEE (Proverum).
@@RRGonzalezUrology Thanks, I will look into it. But I see it is a double blind so I am unlikely to participate. I am too old to take a chance on a treatment then having it be a placebo.
@@MrMartinRome As I explain in this video and in part 2, all patients are eligible. The 33% of patients in the Sham arm all can qualify for the treatment at 3 months. However, the decision is up to you.
Golden State Urology in Sacramento is doing the trial.
Would this treatment also be effective for a large median lobe which is my main issue?
Unfortunately, median lobes are excluded from these stent trials as it would not resolve a ball-valve obstruction.
Best odds are median lobe only (MLO) procedure (adaptation of PVP, GLEP, TURP or HoLEP).
Ricardo R. Gonzalez, MD
thanks so much Doctor! Yes, my urologist used the phrase "ball-valve" and I will be scheduled for his plasma TURP where he will remove my medium lobe and then shave down the sides.@@RRGonzalezUrology
Am interested. Any physicians in the Sioux City Iowa region participating in this trial?
You can check on clinicaltrials.gov and search "LUTS" (lower urinary tract symtpoms) and enter your city to see what trials are near you.
RRG
Are you still recruiting patients for the trial?
Yes, clinical trials are ongoing for prostate stents throughout the US. Trials available are the Expander-2 trial, Butterfly Medical BPH trial, PROVEE Proverum BPH trial. If you are in the Houston area, send email inquiry to BPHtrial@HoustonMethodist.org
Is this procedure what is known as itind?
No. iTIND is already FDA approved and available. These are four new devices that are meant to be potentially permanent implants to create space inside of the prostate to alleviate obstruction. Two of our trials have closed but the Expander 2 study (Urocross expander) and the Butterfly Medical trial remain open at our site and at other US sites available on clinicaltrials.gov
Is this trial still open?
Yes, there are multiple stent trials open.
www.clinicaltrials.gov
Search for: Butterfly Medical, Prodeon Urocross, Proverum PROVEE trials remain open
iTind procedure. Check it out.
iTIND traverses the bladder neck and is removed 5-7 days later. It is a good choice for some, depending on the anatomy.
@@RRGonzalezUrology "It is a good choice for some, depending on the anatomy", Are we talking Median Lobe, could you expand on the anatomy portion of your reply?
@@user-eg1sw7kd6g Exclusion criteria is ball-valving median lobe or prostatic-urethral angle (PUA) steeper than 30 degrees.
thus the measurements and evaluations to see if the anatomy is appropriate for the stent
Does it affect sexual function/ ejaculation?
Not likely. We are confirming but suspect not an issue.
RRG
Don't suppose it helps prostatitis
No it wouldn't.
It took a half of century to come out with something less barbaric! A progress in a treatment of an enlarged prostate is absolutely disappointing, it is an abomination and a disgrace to a medical progress. It has to be the least progressive field of medical science!
I feel your pain sir, having recently started self-catheter routine while I await surgery. 16 inches of rubber tubing we shove up the pee-hole all the way to bladder, several times a day . . . very advanced technology! Ancient Greeks probably did this too. Right up there with lasers, robotic surgery and artificial limbs controlled by brainwaves.