Do you know that no new treatments can be approved unless they pass real life testing with IC patients? When studies and clinical trials seek patient participants, they are conducting critical research to determine if a new treatment can help. I, for example, participated in the first study on PTNS, now known as Urgent PC. Your involvement in clinical trials in 2018 is a gift to other (and future) IC patients in need. IC patient Meredith Small shared her clinical trial experience in My Body On The Line – Take Me, For Example!

There are other advantages. Clinical trials allow you to see many of the brightest clinicians in the IC movement in the USA. Care and treatments are free and ideal for patients who currently lack health care coverage, cannot afford care and/or who would like to try a new line of treatment. Yet, there is always a chance that a new treatment may not work. The research team will share with you potential risks as well. Check out Are Clinical Trials For You? to learn more about the process.

In this special edition of the ICN E-Newsletter, we feature ten trials throughout the USA seeking participants as well as studies in South Korea, Taiwan and Switzerland. Make sure that you click on the “Learn More” links to read about the studies and see where they are being conducted. I encourage you to call study centers for more information too! For those of you who participate, we thank you for the gift of your time and effort! May we find new and better treatments in the months and years to come! – Jill Heidi Osborne, ICN President & Founder

WITHOUT US, NEW TREATMENTS CANNOT BE DEVELOPED!

Clinical Trial Roundup – Spring/Summer 2018

USA – Women in Michigan, Indiana & Ohio!

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

(Principle Investigator: Ken Peters MD – Beaumont Health Urology)

Have you been diagnosed with IC/BPS? If you are a female between the ages of 18 and 85, with urinary frequency, urgency and pelvic discomfort or pain for at least six months, you may be eligible to participate in a clinical research study. The goal of this study is to compare the results of bladder directed therapy (bladder instillations) versus non-bladder physical therapy. All treatments in the study are free. For more information, call: 248-551-3355! Learn more!

USA – Men in the North East!

Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

(Principal Investigator: Louis M Kunkel, PhD – Boston Childrens Hospital)

Researchers at Harvard Medical School are seeking men of all ages who will donate samples to determine if there is a heredity element to chronic prostatitis. Learn more!

USA – Women in Wisconsin, Ohio & Illinois!

Interstitial Cystitis: Examination of the Central Autonomic Network (ICECAN)

(Principal Investigator: Thomas Chelimsky, MD – Medical College of Wisconsin) 

The investigators of this study will determine whether changes in autonomic nervous system responsiveness (ANS-R) contribute meaningfully to the pathogenesis of IC/BPS. Learn more!

USA – Women in California!

Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Bladder

(Principal Investigator: George A. Perdrizet, MD, PhD – UC San Diego)

Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan.  Learn more!

USA – Women in Illinois!

Chronic Pain Risk Associated With Menstrual Period Pain (CRAMPP)

(Principal Investigator: Frank Tu, MD, MPH – Northshore University Health System)
The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic pain risk. Learn more!

USA – Men & Women in Illinois!

Microbiomes of Pelvic Pain

(Principal Investigator: David Klumpp PhD – Northwestern)

This research study seeks to provide more insight as to how the microbiome affects or is affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC), Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often related and are poorly understood, and treatment is often not helpful. The goal of this study is to explain pelvic pain characteristics and causes by studying microbiomes of healthy people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major depression. Learn more!

USA – Women in Pennsylvania

A Pilot Study of the Effects of Mirabegron on IC Symptoms

(Principal Investigator: Kristene Whitmore MD)

Investigators hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle. It has been shown to significantly decrease the number or micturition episodes, urgency episodes, and increased mean volume of urine voided per micturition. Learn more!

USA – Men & Women In Many States Throughout the USA

The MAPP Research Network Seeks Men & Women

California – Illinois – Iowa – Michigan – Missouri – Washington

The MAPP Research Network is the federally funded research team that is studying both IC and chronic prostatitis. In this new study, the second phase of the Symptoms Pattern Study, they are seeking patients who will help them understand and test new potential subtypes of IC, Prostatitis and Pelvic Pain. Learn more!

Urigen 101 Rescue Instillation Study

California – Georgia – Kansas – New York – North Carolina – Ohio –  South Carolina – South Dakota – Virginia

(Study Chair: C. Lowell Parsons – UCSD)

The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received. Learn more!

Genetic Studies in Interstitial Cystitis (IC)

All Patients In All States May Be Able To Participate

(Principal Investigator: Louis M Kunkel, PhD – Boston Childrens Hospital)

Boston Children’s Hospital is collecting genetic material and medical information from families in North America in an attempt to identify genetic factors that may cause IC/PBS/CPPS. We are enrolling families and individuals with IC/PBS/CPPS and their family members (both family members with and without IC like symptoms). Learn more!

SOUTH KOREA – Men & Women

Intravesical HA and CS After Resection of Hunner Lesion

(Principal Investigator: Kyu-Sung Lee, MD, PhD – Samsung Medical Center)  

The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. Learn more!

The Efficacy of Biomarker in Patient With IC/BPS

(Principal Investigator: Myung-Soo Choo MD – Asan Medical Center)

The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome. Learn more!     

BELGIUM – Women

Efficacy, Safety of ASP6294

(Principal Investigator: Astellas Pharma Europe BV)

The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in female participants with BPS/IC. Learn more!

SWITZERLAND – Women

Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

(Principal Investigator Volker Vierect MD – Cantonal Hospital, Frauenfeld Switzerland)

To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease. Learn more