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NIDDK launches breakthrough collaboration between IC and prostatitis research.

On September 17, 2002, the US National Institutes of Health (NIDDK) released a Request For Applications (RFA) inviting researchers to participate in a new series of studies for interstitial cystitis. The new "IC Clinical Research Network (ICCRN)" will fund up to ten research centers to conduct clinical trials to study IC treatments. The IICRN is a follow up to the IC Clinical Trials Group (ICCTG) that was launched in 1997. The NIDDK wishes to build on the work begun by the ICCTG and will conduct additional clinical trials over a second 5 year period. The NIDDK has also issued a companion RFA to establish the "Chronic Prostatitis Collaborative Research Network (CPCRN)", which has identical goals and funding patterns. (Yes, men and women are being treated equally).

While we're always excited about new studies on IC, we are especially intrigued with their first formal combination of IC and Prostatitis Research teams. In both RFA's the NIDDK offered "Over the course of the ICCTG and the CPCRN it has become apparent that there were similar approaches to conducting clinical trials for these two conditions, including development/use of validated symptom indices to measure response to treatment, the need for institutions to become referral centers for these conditions, and challenges to identify novel therapies that allow for rapid accrual of clinical trial participants." Thus, they have decided to create a joint team that will, for the first time, allow both research teams to jointly discuss their studies and share data.

For those who have followed the debate about what to call IC (i.e. interstitial cystitis, pelvic pain syndrome, bladder pain syndrome, Lower Urinary Tract Syndrome, LUDE, etc.), the NIDDK has chosen to use the term "Chronic Pelvic Pain Syndromes" to include both IC and Prostatitis. The aptly named "The Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG)," is a special team created to blend the interests of both the IC and prostatitis researchers. It will include the principle investigators of both 2003 ICCRN and the CPCRN studies and will jointly discuss their research studies and share data from their studies.

Another interesting point in this RFA is an apparent abandonment of the NIDDK diagnostic criteria used in previous studies. As previous ICN articles have discussed, the NIDDK research criteria is extremely strict, requires the use of the now ambiguous hydrodistention and excludes children. The RFA states "For the purposes of this application and these studies, the definition of IC will not be the NIDDK research definition but will be a clinical definition based on the clinical experience of the applicant."

Both RFA's allocate $3.2 million for Fiscal Year 2003, totaling $6.4 million dollars for both diseases. Each center participating can receive up to $320,000 a year.

The NIDDK has a longstanding interest in clinical and epidemiological research for interstitial cystitis and chronic pelvic pain disorders in men. In 1991, the Interstitial Cystitis Database (ICDB) study was initiated. The ICDB Study was a 5-year study of over 600 men and women with symptoms of urinary urgency, frequency, and pelvic pain. Reports have described the impact of IC on quality of life, treatment patterns and the relationship between findings from bladder biopsies with patient symptoms.

As a follow-up to the ICDB Study the NIDDK established the Interstitial Cystitis Clinical Trials Group (ICCTG) in 1997 to plan and conduct randomized controlled clinical trials of promising therapies for patients with IC. Two clinical trials have been conducted by the ICCTG; one studied oral therapies (Elmiron & Hydroxyzine) while the other trial administered BCG treatment intravesically. Results for both are still pending.

The goals of the 2003 ICCRN study include:

1. To establish a collaborative group of clinical trial centers with clinical expertise in chronic pelvic pain, clinical pain management and IC.
   
2. To design randomized controlled clinical trials to treat the symptoms of IC
3. To develop and conduct ancillary studies which will provide further understanding of IC.
4. To determine if there is a different response to therapy between newly diagnosed and chronic, long-term patients with IC
5. To recruit sufficient numbers of patients with IC, including newly diagnosed, into these clinical trials
6. To jointly work with the other IICRN investigators to study the results
   
7. To participate in the Urological Chronic Pelvic Pain Syndromes Collaborative Group to facilitate clinical trials in both IC and chronic prostatitis
   
8. To develop a clinically relevant definition of the urologic chronic pelvic pain syndromes, based on thhe clinical findings from these and other related clinical studies

How will the study be managed?

A steering committee composed of the PI's and DCC and NIDDK Scientist will serve as the main governing board for the project. Each has a single vote. All major scientific decisions will be determined by majority vote of the Steering committee, who will determine the organization of the network, clinical protocols, conduct & monitoring of studies, and reporting of results.

Who is eligible to apply?

Principle Investigators must be physicians with clinical expertise related to IC and/or chronic prostatitis and the urologic chronic pelvic pain syndrome. PI's are encouraged to establish a multi-discplinary team including expertise in such areas as chronic pain management, behavioral medicine and other chronic pelvic pain disorders.

What criteria will be used to determine who will participate?

The most important criteria for research centers is their ability to recruit a sufficient number of patients. Each center will need to have the capacity to randomize 4-6 study participants each month beginning in year 2 of the program and continuing through year 4. (48-72 patients a year). It is likely that one of the trial protocols will require 1/3 of the participants to be newly diagnosed patients.

Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK. All applications will receive a written critique, be assigned a priority score, receive a secondary review from the NIDDK National Advisory Council.

Applications are assessed in several categories, including: (1) Patient access, (2) Study Design, (3) Qualifications and experience, (4) Willingness to participate in the Network and the UCPPSCG, (5) institutional resources for patient care and followup.