Clinical research study conducted for patients with IC/PBS

Feb 12 2010

A clinical research study is being conducted for patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS), a chronic bladder disorder characterized by intense pelvic pain, urinary frequency-urgency, and pain during sexual intimacy (www.PainfulBladderStudy.org). It is estimated that as many as 1.3 million people in the U.S. have been diagnosed with this disease and many more remain undiagnosed.

There can be various underlying reasons why many people are undiagnosed: First, public awareness about IC/PBS is very low. Second, IC/PBS can be hard to diagnose because its symptoms mimic those of other painful bladder conditions.

In women, the symptoms of chronic pelvic pain, urgency, and frequency may be misdiagnosed as a recurring urinary tract infection, overactive bladder or endometriosis. In men, the symptoms may mimic medical problems such as chronic nonbacterial prostatitis or benign prostatic hypertrophy (enlarged prostate). An accurate diagnosis of IC/PBS is most often confirmed after numerous medical tests have been conducted.

IC/PBS is more common in women than men, and is a disease with significant impact on daily activities such as shopping, household chores, sleep, job productivity, and an intimate relationship. Those affected by this condition try to cope with its chronic burning, piercing pain and other symptoms.

Clinical trials are the only way to bring new pain medicines to market for IC/PBS, and to achieve this, clinical trials need patients with IC/PBS to take part. For a limited time, leading medical centers around the country are participating in a clinical research study that will examine the safety and effectiveness of an investigational medicine for IC/PBS pain and other symptoms. The study is enrolling adults 18 years or older who meet specific study criteria such as a confirmed diagnosis of IC/PBS. Adults currently living with symptoms of severe bladder and pelvic pain, urinary frequency and urgency may also be eligible for the study. People meeting those criteria are encouraged to visit the study's website (www.PainfulBladderStudy.org) and self screen online to see if they may qualify for study participation.

This pain study provides those with a confirmed IC/PBS diagnosis with close monitoring of their IC/PBS symptoms, ongoing medical evaluations (at no cost), and the opportunity to possibly advance a future medicine for IC/PBS pain. The study is 24 weeks long with a 2-8 week medical evaluation period. You will be required to have a cystoscopy if you have not had one within the last 2 years.  Each day, study participants will carefully track their pain levels in a digital diary provided by the study doctor. The study also involves at least seven (7) office visits and three (3) check ups by phone.  Patients diagnosed with IC/PBS and experiencing moderate to severe bladder and pelvic pain, urinary frequency and urgency, are encouraged to seek out this clinical research study by visiting website www.PainfulBladderStudy.org to obtain more information about taking part.