NIH-Sponsored Chronic Prostatitis Collaborative Research Network

Back to ourreport on the November 1998 NIH-Sponsored Chronic Prostatitis Treatment Workshop

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November 5-6, 1998

Workshop on Chronic Prostatitis Treatment Strategies

Scope of Study Discussion
About this page:
At the meeting, researchers discussed what should and should not be done in the NIH-sponsored cohort study and tried to get on the same page in terms of their understanding of the study's goals and limitations. The meeting was open to comments, so at some points, members of the meeting interrupted the speakers for comments.
The left column contains the name of the speaker. For complete titles, degrees, affiliation and contact information (E-mail and phone) click on the name or go tohttp://prostatitis.org/nihbase.html
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Dr. NybergCollecting pathology on a large multi-site study on BPH, over 40 per cent have a pathological diagnosis of chronic prostatitis.
The main purpose of the workshop, held Nov. 5-6, 1998, was to discuss and strategize which treatment strategies for prostatitis would be examined as a second stage of the NIH Cohort study, beginning sometime in late 1999. The cohort study, however, was already beginning as the meeting was held. Planning for the cohort study preceded the meeting, just as the meeting was part of a planning process for the treatment studies to begin later.
Dr. Leroy M. Nyberg, Jr., Ph.D., M.D., Director of the Urology Program at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIDDK/NIH), pointed out that in parallel, NIDDK/NIH was also collecting pathology data on a large multi-site study on Benign Prostatic Hyperplasia (BPH). Nyberg noted that in that study, early data indicate that over 40 per cent of men with BPH have a pathological diagnosis of chronic prostatitis.
J. Richard Landis, Ph.D., of the Department of Biostatistics and Epidemiology at the University of Pennsylvania, explained the parameters of the cohort study. Dr. Landis stated that some of the centers involved have already enrolled more patients than they need for first year.
Dr. LandisThe goal is that some time between year two and year three (in 1999) we hope to do randomized clinical trials. But before we do that, we want to have a common data structure that is collected on every patient.
The cohort study is designed to look at the natural history of prostatitis, or, more correctly, the treated natural history, of the syndrome. We are hoping to enroll some control patients, also.
There had been quite a bit of discussion in the meeting about the term 'Natural History.' The concept of the term is that there is a typical progression in prostatitis, there are typical things that happen in prostatitis patients, and there are typical responses to treatment. It is an overriding presumption of science that a disease process or disease syndrome is not going to be completely random and without any organization, and that if the pattern or organization is not known, it is worth trying to discover.
Several comments from the meeting urged clarity on the point that because nobody sees patients that have pure, untreated prostatitis, nobody really has a clue what the truly "natural" history of the disease would be. Nearly all patients are treated by some drug, therapy, herbal preparation, procedure, surgery or other response before they are examined and classified by researchers. Dr. Landis' point in referring to "treated natural history" is that even the typical course of prostatitis that is treated has not been adequately described in the medical literature.
Dr. Landis So what we want to have in common, is a symptom index, an appropriate set of clinical outcome measures, and a series of targeted case control studies. Then we hope to soon test therapies, where we have validated diagnosis, identification of baseline strata, a validated symptom severity index, and validated outcome measures."
We have requested each center to recruit 35 patients per year. So what we will have will be a cohort of 630 patients. We hope to have more than 100 subjects for our three-year follow-up."
It is considered normal in "cohort" studies involving a large number of patients to "lose" patients over time. One-fifth of Americans move every year, people die, and patients lose interest in participating in studies where they are subject to extra questions and possibly extra needle pokes. Also, medical studies typically don't have funding or staff to go out and look for former study participants who have been "lost." If they don't answer a mail or telephone survey, they are presumed "lost," even though a cursory search might indeed "find" them. Landis presumed, based on this overall pattern, an attrition rate of nearly 50 per cent per year from the study.
Dr. Krieger How many randomized clinical trials could you do with a six month follow up? Krieger and others had noted throughout the meeting that many of the presentations from the international group had involved only a few to a few dozen patients, and that clinical trials with larger numbers of patients were needed.
Dr. LandisIf [ the various centers involved ] do clinical trials they will use some of these patients but will recruit other patients for the clinical trials.
Dr. NickelWe hope to recruit other [ additional ] clinics and doctors for clinical trials later
Dr. McNaughton-Collins Gives some background on how the NIH symptom index was prepared.]-- We did a literature search, we had focus groups, we tested the symptom index on prostatitis patients and we had two control groups, BPH patients and healthy young men. We were looking for a one page index. We found, for example, that a lot of men are stoic and don't want to admit that they worry, so we asked them if they 'think about it' a lot.
Dr. Landis Introduces the goals of the cohort study ]
We are going to permit enrollment of all ages -- with parental informed consent. Must have discomfort or pain for at least 3 month period sometime during the last 6 months.
Unknown commentatorThree months is too long. You'll be dealing with the hopeless cases. You will see who you already see.
Dr. NickelWe didn't want patients who had any kind of pain at any time.---We learned from our patients that every patient has a different story. In this study we have to use a concept that we want a group that we can actually follow. Once we start this cohort, there'll be room for change. Some patients will be screened 'out' of this study, if we find we are excluding patients, we'll sit down in the study [ committeesand change the criteria.
Dr. LandisWe will have a patient log at the data center.
Dr. Landis introduces the idea of "exclusion criteria," or factors which might keep an individual patient out of the cohort study. The idea, as discussed, was that one needs to have a similar set of patients to be able to draw any conclusions from differing outcomes; if there are too many factors, conclusion become very difficult to form. No patient is going to be excluded from care; they are just excluded from the study's database.
We're going to exclude patients with
  • cancer
  • herpes
  • IBD
  • chemotherapy
  • active stricture
  • neurological disease
  • history of TURP, TUMP, TUNA or other surgery
  • or a psychiatric disorder.
Dr. KriegerBut at least 40 million people this country have serological evidence of genital herpes.
Unknown commentatorWe don't want to leave that out because that might be the key.
Dr. Nickel [Responding to commentator]I 'd like to re-look at that criterion based on your comments.
Dr. LandisThere are also deferrals:
  1. Patients who have received antimicrobial drugs in the last 3 months will be deferred for three month, so at the time of study they will have been treatment-free for 3 months.
  2. Patients with a Urinary Tract Infection over [ a certain standard. Did not catch the standard. Dr. Landis? Anyone?
  3. Anybody with a confirmed diagnosis of a sexually transmitted disease [ i.e. "traditional STD's "such as gonorrhea and syphilis, not withstanding some doctor's assertions that prostatitis is transmitted sexually
  4. Anybody who has had a prostate biopsy the last three months
  5. Any patient diagnosed with acute epididymitis for the past three months.
The point is, we want to start with the same set at each of the study's several centers.
Dr. KriegerI'd like to discuss # 10, the exclusion for TURP etc.
Dr. NickelWe need to exclude these patients because once a patient has had this procedure, we can't any longer look at the causes of why he got prostatitis in the first place.
Dr. SchaefferYou have to start somewhere. It's important that the study is reviewed constantly.
Dr. PottsDo you have some data, I'd like to see some third party to do a male pelvic floor assessment. In other words, Dr. Potts does these assessments, and she'd like to see other doctors doing them so she can begin to assess whether her results are close to those of doctors working at other clinics with other sets of patients.
Dr. NickelThat's being done at many individual centers.
Dr. NybergBefore we start an intervention trial, we'll have to have a review by an external review committee, and they will have final input into all the criteria. To expand the scope, to get more realistic patients, we do want to expand this study internationally, to get a much larger input. What we have decided so far is not carved in stone, and is always up for review. We want your input.
[ Editor's note: The discussion reported here was taking place among leading doctors interested in prostatitis, so that Dr. Nyberg and NIH/NIDDK can get input. To their credit, they also invited representatives of The Prostatitis Foundation and other patients to attend the meeting. When Dr. Nyberg says "we want your input," he's speaking to doctors at the meeting, but, your editor has a sense that Dr. Nyberg will also look at reasoned inputs by patients as well.

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