Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the
genitourinary tract. IC/BPS disproportionately affects women with over 80% of patients with
IC/BPS as female.[1] Like other chronic pain conditions, IC/BPS is physically and emotionally
taxing on patients. IC/BPS costs the United States over $100 million annually due to direct
healthcare costs and loss of worker productivity.[2] The exact pathophysiology of the disease
is unknown, leading to a limitation in our ability to treat the disorder effectively. The
current leading etiologic theory is that IC/BPS is a neurologically-derived chronic systemic
pain syndrome due to its association with musculoskeletal pelvic pain, irritable bowel
syndrome, chronic fatigue syndrome, fibromyalgia, and vulvodynia.[3-6] Although several
options exist to treat IC/BPS, therapeutic effects are often transient.[7,8] Previous studies
in chronic pain disorders have shown that multimodal treatment is more effective than
single-agent treatment,[9,10] so future therapy should aim to augment rather than replace
current treatments. Bladder instillation is a commonly used treatment in which a mixture of
different agents are instilled into the bladder to improve IC/BPS symptoms. The data on the
efficacy of bladder instillations, as well as which ingredients in the mixture are effective,
is limited.[11,12] Small studies have shown the potential of steroids in decreasing IC/BPS;
the mechanism of action is hypothesized to be due to decrease inflammation in the bladders of
these patients.[13,14] The knowledge gap that exists is the necessity of a steroid in the
bladder instillation treatment for IC/BPS symptoms especially since this tends to be the most
expensive ingredient.

To evaluate the utility of a steroid in the bladder instillation treatment of IC/BPS, we
propose a randomized, double blind, controlled trial that will compare the efficacy of
bladder instillations with and without triamcinolone acetonide on IC/BPS symptoms in women.
We hypothesize that the addition of triamcinolone acetonide in bladder instillation therapy
will result in a more robust treatment response than bladder instillations without
triamcinolone acetonide. Our rationale is based on 1) the results of small studies that
showed improvement of IC/BPS symptoms with use of a steroid and 2) the hypothesized mechanism
of action of steroids decreasing inflammation in the bladder.

Inclusion Criteria:

- Women 18 years and older

- Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index)
of the O'Leary-Sant questionnaire who have selected bladder instillations as part of
their IC/BPS treatment

- Suitability for follow-up

Exclusion Criteria:

- Contraindications and/or allergies to the ingredients used in the bladder
instillations

- Diagnosis of idiopathic thrombocytopenic purpura

- Does not desire to undergo bladder instillation therapy or unwilling to undergo
bladder instillation therapy on schedule mandated by study

- Have a known alternative diagnosis explaining bladder pain symptoms that would
preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract
infection with bacteria or fungus treated within last 2 weeks or diagnosed at index
visit, bladder injury or trauma within the last 30 days)

- Inability to speak or read English

- Bladder instillation within the past 4 weeks