Tb test for BCG study

[Lyn40]

I am weighing the pros and cons for taking part in the BCG study. I was told that you may always test positive for Tb after the BCG instillations. Does anyone know if that may be true?
Thanks, Kim

[Derrick]

Hi,

Yes, it is possible to test positive for TB after undergoing a course of BCG.

I'm currently in my 5th month post BCG treatment thru Standford Medical Clinic. I wouldn't say that I'm any better and I'm no worse than when I started. I'm almost positive that I received BCG instead of the placebo as I got some of the known side effects that come with BCG treatment.

There was also a really good article on Medscape that came out last week. All males should probably read this before undergoing BCG treatment.

http://www.medscape.com/viewarticle/...02/7002/7001/- 1

[Optimistic]

Hi Kim, I am trying to decide whether I will try the study of BCG too. I have quite a ways to drive or get driven to get to the study. (about 2 hrs drive. I would love to hear any others that have tried the study or are taking it now. I am sure you would also. Want to make an informed decision on it. Any others????? Optimistic
I am also wanting to try some herbal treatments too. Anyone try this??? <img src="graemlins/grouphug.gif" border="0" alt="[grouphug]" />

[Anita420]

Kim, in case nobody's told you this about BCG: I've had 3 treatments so far (one per week), each more excruciating than the last. Not at the time of instillation but starting later that day and lasting several days! I don't know whether this happens to everybody. But I don't think I'll continue with BCG. Pain so bad that it required controlled drugs to endure it. This is a perfect instance of the cure being worse than the disease. It seems that the way BCG works is to destroy the lining of the bladder so that a new, healthier lining will replace it. Yikes!

[Lyn40]

Anita,
I am so sorry to hear that the BCG instillations were so painful for you. Are you going to stop after three? I hope the medical facility is cooperating with your situation. I would be curious to know how many others had the same experience.

I ended up not doing the study. I had another medical problem get in the way of being able to commit to the next 8 weeks. Besides, my instincts told me not to follow through with it.

I'm sending prayers your way,
Kim

[Debra]

I did an 8-week course of BCG in the spring of 2000. I saw no improvement from it, and endured 8 weeks of increasing pain coupled by feeling like I had the flu.

On a positive note, though, for those who may be worried, I have never tested positive for TB since (and I work in a hospital, so I have to get tested regularly). I was relieved about that!

Debra

[lm2]

Derrick, what does this study say about BCG? It doesn't seem to let me in. I wanted to do this but was afraid so I chickened out. It doesn't seem like anyone is having good results with it anyway but I don't know what else to do, so I'm still curious about this.

[ICNAsstMgrDiane]

I had the BCG instills and they helped my IC dramaticaly. Still today I only void about 7-8 times a day. Here is a copy and paste of my story. (I have posted this on previous occasions)

BCG: My Story

In July of 1998, after a great deal of consideration, my physician suggested that even though not approved for the treatment of Interstitial Cystitis, but because of the promising results of clinical trials, that I should consider intravesical BCG as a possible option.

As a proactive IC patient, prior to committing myself to BCG instillations, I took to the computer and researched BCG in general and as a possible treatment option for IC. In my research many questions came to mind that I knew that I needed answers for. Some of the questions that I needed answers for were, Could I become infected with the TB Virus? Could I spread the TB virus to others? What side effects will I have? What precautions should I take? Would my bladder tolerate holding the medication for the prescribed amount of time?

After reviewing my concerns with my physician and understanding the all the pro's and con's of BCG, I decided that BCG was an option for me. Prior to the start of the 6 weekly instillations, I had an IVP and a Sonogram of the kidneys and uterers. This was done to make sure that my kidneys and uterers were functioning normal and that there was no chance of the medication entering into my kidneys. I also started a voiding diary so that we could determine and monitor the effectiveness of the BCG.

I was also given instructions from my physician in reference to the preparations that I needed to do before and after the procedure. I was advised not to drink any fluids four hours prior to the instillation, and to take an antibiotic after the procedure and two doses the following day to help with the prevention of infection due to catherization.

During the course of treatment, I stopped all medications that I was taking for IC except for my pain medications and my self-help strategies i.e., heating pad, ice packs, electrical stimulation and TUMS.

I started my initial treatments on July 31st, 1998. Because BCG is most effective when it is instilled once a week for a period of six weeks, we had to abandon the initial treatment plan due to major setbacks.

On October 2nd, 1998 I Anxiously arrived at my physician's office, BCG and solution in hand, ready to start my six weekly instillations. A little nervous, but thinking to myself, that this may be the one option that can bring some hope. As the physician was ready to administer the catheter, I requested that lidocaine be administered first. Unfortunately, I was told that it would effect the effectiveness of the BCG. So the catheter was inserted and the BCG/solution was administered.

I was given directions to make sure that I held the medication for 45 minutes. I questioned this, because I was under the impression that the medication should be held for 2 hours, rotating from front to back, side to side in 15-minute intervals. I was determined to follow the instructions of the clinical trials, so I went home and rotated from side to side, back to front. After 1-½ hours, I was ready to burst, so I emptied my bladder. As the solution was releasing itself from my bladder there was a slight burning sensation. Other than the slight burning after the initial void, the effects of the first night were minimal.

On Saturday the day after the treatment, I woke up with a headache and feeling very sluggish however, the BCG did not increase my pain levels. The headache lasted two days, but the fatigue continued throughout the six instillations.

My second instillation was the same as the first, there was burning after the medication was voided and lasted a few hours.

When I went for my third instillation, this was a little different. The medication burned while inside my bladder, where before the burning only occurred after I emptied my bladder of the solution. When I voided I could actually see the sloughing of the bladder wall in my urine. I was a little nervous, but I knew that this was one of the actions of BCG. For three days after the instillation my pain levels were a slight higher and I started taking my pain medications on a regular schedule.

I started another three-day voiding diary, so that I could monitor myself to see if there had been any improvement in my frequency since the initial treatment. (see below)

Before the next three treatments, I started to take my pain medications prior to the instillation. I noticed by doing this that it helped with the discomfort that was associated with catheter insertion, the burning while the medication was inside my bladder and also helped in allowing myself to hold the medication for a longer period of time.

After the fourth, fifth and sixth treatment I could actually see more of the bladder lining sloughing off. I also had darkened/dry blood in my urine, but I was advised that this was normal. My pain levels seemed to increase a little more, but not to the extent where it interfered in my daily routines.

Questions that I have been asked regarding my experiences with BCG?

1. When did I notice the initial change in my IC symptoms?
I noticed a slight change in my IC symptoms after the 5th treatment. I felt as though I was able to hold my urine longer between voids. However the pain levels did not change.

2.How long after the 6th treatment did I feel that the BCG was really working?
Probably two months after, when my nocturia went from 3-4 times a night, to 0-1 times per night.

3. How long did it take to notice a change in my pain levels?
The pain waxed and waned for two months, having a few bad days every couple weeks. By the third month, I had very little pain. By the fourth month I felt as though I was symptom free.

4. When did you notice an improvement in your frequency and urgency?
Prior to BCG, I was voiding on the normal, 16-20 times a day. With-in the first month of the 6th treatment, I kept a voiding diary, which showed that my daily voids were slowly decreasing. By the 3rd month, I was retraining my bladder (bladder protocol), and trying to see if I could wait and empty every 3-4 hours.

5. How am I doing now, 7 months after the last treatment?
My voiding patterns are just about normal. I do have days that I have freguency, but the urgency has improved dramatically. Before the BCG, if I had the urge to void, I had to go then. Now I am able to hold it with out the urgent feeling.

6. Would I do it all over again?
Yes…I feel that this shows definite promise.

7. Do I have any other concerns after the BCG treatments?
I suffer from chronic bladder infections. I am paranoid, that the infections will have an impact on the progress that I have made with the BCG.

**************************************************
What is BCG? Bacillus Calmette Guerin

BCG -Tice® also known as Bacillus Calmette Guerin or the Tuberculosis bacteria/virus. It is a vaccine, composed of a live weakened strain of "Mycobacterium bovis" which is derived from cows. BCG is administered in two ways, either by intradermal injection or intravesical. 1
Intradermal injections of BCG-Tice®, Outside the US, has been used for the prevention of Tuberculosis. Intravesical treatment of BCG-Tice® is FDA-approved for carcinoma in situ (CIS) of the bladder. In January of 1994 a published report in, Urology 1994 Jan;43(1):121-4, titled "Bacillus Calmette-Guerin immunotherapy for refractory interstitial cystitis" by Dr's. Zeidman EJ, Helfrick B, Pollard C, and Thompson IM; Urology Service, Brooke Army Medical Center, San Antonio, Texas, suggested that BCG may be an effective treatment for Interstitial Cystitis.2

How was BCG first discovered as a possible treatment for IC?
BCG treatment for Interstitial Cystitis was found by accident. A woman who was thought to have had carcinoma in situ of the bladder underwent BCG treatments. She was misdiagnosed and it was determined that she had interstitial cystitis and not carcinoma in situ of the bladder. However, after completing the treatment course of BCG, her symptoms of Interstitial Cystitis resolved.3

How is BCG administered?
BCG is administered (as per research trials) in six weekly instillations. The intravesical dose consists of one vial of Tice-BCG suspended in 50ml preservative-free saline.3 The BCG and diluent is administered through a catheter. You are asked to hold the medication in place for 2 hours, Rotating every 15 minutes from side to side, back to front. This enables the medication to be distributed equally in the bladder.3,7

In order to hold the medication for this suggested period of time patients should not drink fluids for four hours before treatment.

(Note: Many physicians that are doing BCG treatments out of the study trials, require that you hold the medication for at least 45 minutes.)

What are the possible side effects?
"Flu-like" symptoms: fever, shaking chills, increased fatigue, nausea/vomiting, headache or dizziness, joint pain, coughing, skin rash, blood in the urine, severe urinary symptoms, or other disturbing effects.7

Can you contract the TB Virus while on BCG?
One of the risks of BCG is becoming ill from the treatment with high fever, chills or sepsis. It is unlikely to actually contract TB. The risk of a serious side effect is low based on our experience in bladder cancer and would occur more likely in men due to catheterization of the prostate and potential bleeding associated with this. (Quoted, Dr. Peters: Chat transcript May 18th, 1999)

What Special Precautions Should Be Taken After Receiving BCG Treatment?
For safety reasons, urinate to expel the liquid by sitting down on a toilet.
Add two cups of chlorine bleach to the toilet bowl after urinating, and do not flush for at least 15 minutes.
Repeat this process each time you urinate for 6 hours after each treatment.
To avoid contamination, cleanse your hands and genital area thoroughly each time you urinate Drink plenty of fluids to wash out your bladder during the hours after the Tice BCG treatment.

4. How does BCG work as a treatment option for IC?
The method of action of BCG is still unknown, However, it is thought that "efficacy of BCG in treating Interstitial Cystitis may be due to stimulation of type 1 T helper cell response, allowing for destruction of stressed immunogenic cells and promoting reparitive conditions... Correcting the underlying abnormal immunoligic event may be the reason why intravesical BCG is effective in treating interstitial cystitis.""3,5,6

Another possible factor, as observed in uncontrolled trials, is evidence that "Interstitial cystitis may be associated with low urinary nitric oxide level and increasing nitric oxide in the urine has shown to correlate with an improvement in symptoms. Intravesical BCG, has been shown to be a potent stimulator of urinary nitric oxide in the bladder cancer patients".5,6

Intravesical BCG may be effective in treating IC by correcting an aberrant immune imbalance in the bladder, leading to long-term symptomatic improvement, as reported in, Urology 1999 Sep;54(3):450-3.8


What does BCG do to the bladder lining?
BCG is considered less caustic than Silver Nitrate or Clorapactin. It slouths off or eats away the tissues of the bladder wall. Silver Nitrate or Clorapactin burn away the tissue of the bladder wall.

What results have been seen in clinical trials? please note that this study is one of the initial BCG studies. For current research, please see the ICN Library

-12 patients elected to receive BCG in an open label study
-response rate in the open label study was 67%
-2-year follow-up: 8 of 9 patients or 89% experience a positive clinical response with no additional treatment for interstitial cystitis
-voids per day decreased 31%
-nocturia improved 54%
-mean voided volume increased 61%
-pelvic pain decreased 81%
-vaginal pain decreased 71%
-urgency decreased 71%
-dysuria decreased 82%
-well-being improved 54%
-Rand-36 quality of life survey overall improved 64%.
-Of the 9 subjects who received BCG and responded, 7 complained of dyspareunia at baseline but at a mean 27-month follow-up dyspareunia resolved in 86% (6 of 7)
-6 of the 8 long-term responders were taking narcotics to control pain at baseline and at follow-up no patient reported narcotic use.
-14 of 15 subjects who received BCG (93%) stated that they would have participated in the study again
-60% BCG response rate compared to a 27% placebo response rate was found
intravesical Tice strain BCG has been demonstrated to be safe, effective and durable in the treatment of interstitial cystitis. Of the subjects responding to 6 weekly intravesical instillations of BCG 89% continue to have a positive clinical response with a mean of 27 months of followup. Of the subjects who received BCG and did not respond there was no worsening of symptoms.
[li]Further research is continuing. 3

Who manufactures BCG-Tice®?
BCG -Tice® was developed at the University of Illinois. It is manufactured by , Organon Teknika Corporation, 100 Akzo Avenue, Durham, NC 27712 and distributed by, Organon Inc, West Orange, NJ

[lm2]

Thanks Diane for sharing your story. I do remember reading it before and it always gave me hope. So it put you in complete remission? Do you know other people who have had good results too? I was wondering why you don't see hardly anyone talking about it - I know it's still experimental but I am wondering if it ended up not being as effective as initially thought. One of the doctors I saw didn't have such good results with the 5 patients she treated with it, so I got very discouraged then. Also I often see people here saying they have tried "everything" but not that so I wonder if some doctors just do not want to do it as a treatment. I know my mom doesn't want me to do that. I wonder what the latest study that Derrick was in will show in terms of efficacy. I'm seeing my doctor on Monday and just feel like I want to have it in my mind something else to try because I've basically tried everything and I don't know what else to do now.

I wonder if this can help people with urethral symptoms?

[darlene]

I have posted about this in the past, but there are new people on here all the time. If you decide to do BCG, make sure your doctors know about all of the meds you are taking. Because BCG is a weakened, not killed, bacteria, it can cause serious side effects with other drugs. Many others, like myself, suffer from multiple illnesses. I take immune suppresants for my Crohn's disease, and have also taken Remicade, in the past. In the unlikely, but possible event, that the BCG , enters the blood stream, it could be fatal when combined with these drugs. It is up to us, to make sure this doesn't happen. We must keep all of our doctors informed about all of the meds we take, because, in the end, we pay the price for any mistakes!

[Rowena]

I feel really ignorant! I have never heard of this before. I plan to do some research if my Algonot ever quits working. Thanks everyone for sharing.

[peachycajun]

After reading your story Diane, I feel so much better about trying BCG. My dr has decided to try this with me. Except it will be for 8 weeks. I'm really nervous, but to the point I will try anything. My dr says she has used it since 1999 and has about an 85% success rate. That's good enough for me!

I dropped my script off yesterday and they are suppose to call me when it is ready. After I have my meds, I will call and set up appointments to begin.

Thanks for sharing your story.....I will keep everyone updated with my treatments.

danielle