Clinical trial to test Singulair to treat bladder pain syndrome

Source:Vanderbilt University Medical Center

Vanderbilt University Medical Center is currently enrolling women to participate in a study looking at the drug Montelukast to treat interstitial cystitis/bladder pain syndrome (IC/BPS).

The study is the first controlled trial of Montelukast, also known as Singulair, for this condition. The randomized, placebo-controlled, crossover trial will follow the bladder symptoms of women with IC/BPS, a syndrome that presents with pelvic and urinary symptoms such as frequency or urgency.

While various treatments are available, they are not always effective and side effects can be limiting, said Renee Ward, M.D., assistant professor of Obstetrics and Gynecology.

“IC/BPS, a chronic disease that has no cure, dramatically affects women’s quality of life,” said Ward. “The current therapies, some of which are FDA approved, have a lot of side effects. One medication can take up to 12 months before the patient experiences any benefit while another can be very sedating and cause weight gain.

“Our goals of therapy are to decrease the frequency with which they have pain flares as well as decrease the intensity of the flares when they have begun. This medication is very promising based on the basic science studies.”

Ward said she hopes to determine if Montelukast, a leukotriene inhibitor, is able to decrease inflammation in the bladder and determine if it is a good treatment option for women with this condition.

Participants will be randomized to start either Montelukast or a placebo drug. Each drug will be administered for eight weeks with a two-week washout period between the two treatments.

“Montelukast decreases inflammation and has been used off label for IC/BPS for some time, but we want to have data to support its use, as well as to document side effects for this population,” she said. “If it works, we will have another well-studied therapy that we can offer women to help improve control over bladder pain.”

Study participants must be at least 18 years old, diagnosed with IC/BPS and have tried at least one medication for treatment.

“Women are so frustrated and on multiple medications,” she said. “They are very ready for additional therapies. IC/BPS is truly life-altering when it is not controlled.”

Source:Vanderbilt University Medical Center

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