Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

BACKGROUND/SCIENTIFIC RATIONALE Interstitial cystitis/bladder pain syndrome (IC/BPS) is
associated with significant morbidity and poorly understood underlying pathophysiology.
IC/BPS comprises a symptom complex defined by the American Urological Association (AUA) as
"An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary
bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the
absence of infection or other identifiable causes"(1). Up to 11% of women are affected by
IC/BPS (2), and the disorder may be significantly underdiagnosed (3). A 2008 study (4)
indicated that 43% of patients with IC/BPS require multimodal therapy with an average of 7-12
yearly clinic visits at a cost of $9,000/patient. Twenty percent of women report wage losses
of >$4000 per year (5). Current theories for the cause of IC/BPS include infectious agents, a
defective uroepithelium permeable to toxic substances, structural abnormalities, neurogenic
inflammation, increased neurologic sensitivity, or an allergic response involving increased
numbers of bladder mast cells (6). Despite these theories, reliable treatments remain
elusive. Most IC/BPS treatments target one of these proposed mechanisms, involve trial and
error of several therapies (1), and often utilize multiple modalities (7). Treatment success
ranges from 47-93% for intravesical instillation to 21-64% for oral therapies, with
discontinuation rates up to 80% due to intolerable side effects (1). Efficacious treatments
for IC/BPS that apply to a greater proportion of patients with limited side effects are
urgently needed.

Mindfulness Based Stress Reduction (MBSR), a Complementary Alternative Medicine (CAM)-based
therapy, potentially fulfills this need. The Interstitial Cystitis Association (ICA), a
patient-led organization, sponsored a survey of 2100 IC/BPS patients. They reported that 84%
had tried CAM therapy and 55% of those surveyed reported that their physicians had
recommended CAM (8). According to a 2007 National Health Interview survey (9), CAM is used by
38% of adults in the United States. MBSR has been successfully employed to treat chronic pain
syndromes and has been used in disorders such as multiple chemical sensitivity, chronic
fatigue syndrome, fibromyalgia (10), and irritable bowel syndrome (IBS) (11). These disorders
may coexist in patients with IC/BPS (6). In IC/BPS, increases in stress are positively
correlated with increased pain (12); and one study reported that up to 80% of IC/BPS patients
found stress reduction decreased their symptoms (8). MBSR was found to be efficacious in the
treatment of urgency urinary incontinence, a urinary disorder closely related to IC/BPS (13,
14). While MBSR has shown therapeutic promise in conditions that are similar to or coexist
with IC/BPS, and has been rated as helpful by patients suffering from IC/BPS, rigorous
randomized clinical trials investigating the efficacy of this intervention are lacking (8).

OBJECTIVES/AIMS/HYPOTHESES Ultimately, the investigators long-term goal is to provide a
much-needed treatment for IC/BPS using patient-centered therapy such as MBSR. The objective
of this research is to conduct a pilot RCT to explore whether MBSR is acceptable to patients
and results in improved symptoms when added to IC/BPS 1st and 2nd-line treatments as
recommended in the American Urological Association guidelines (see Table 1). The
investigators hypothesize that an 8-week MBSR class will be acceptable to IC/BPS patients and
that MBSR used in conjunction with traditional 1st and 2nd line therapies will improve
symptoms compared to IC/BPS patients using traditional 1st and 2nd line therapies alone. If
this pilot study demonstrates effectiveness and acceptance of MBSR, it would provide data to
justify a larger randomized controlled trial. If the investigators' hypothesis is supported
with this exploratory study, MBSR, an understudied and potentially underutilized therapy,
will expand treatment options for IC/BPS patients. The investigators' aims in pursuit of this
goal are; Aim #1: To determine whether the addition of MBSR to 1st and 2nd line therapies as
recommended by AUA guidelines improves IC/BPS symptoms as measured by the primary outcome the
Global Response Assessment (GRA), as well as the O'Leary-Sant Symptom and Problem Index
(OSPI), and Visual Analog (VAS) pain scale. Hypothesis: The investigators hypothesize that
MBSR will be an effective treatment for IC/BPS as measured by the validated GRA, O'Leary-Sant
and VAS pain scales.

Aim #2: To evaluate whether participation in a structured MBSR class will improve quality of
life, sexual function and overall self-efficacy in patients with IC/BPS, based on changes in
the Short Form Health Survey (SF-12), Female Sexual Function Index (FSFI), and the Pain
Self-Efficacy Scale (SES). Hypothesis: The investigators' hypothesize that MBSR will improve
quality of life, sexual function and impressions of self-efficacy as measured by these
validated scales

Inclusion Criteria:

- Actively utilizing but are incomplete responders to the AUA guideline's 1st or 2nd
line therapies

- Non-pregnant women ≥18 years old

- Meets IC/BPS diagnosis by AUA guidelines, OSPI >8

- Negative UA or Urine Culture at time of diagnosis or within 2 months if no change in
symptoms over that period

- Able to speak and understand English

- Currently undergoing 1st or 2nd-line treatment as per AUA guidelines, for at least 4
weeks duration

Exclusion Criteria:

- Untreated Urinary tract infection

- Unevaluated Hematuria

- Urinary retention

- Pregnant or lactating women

- History of cystectomy, augmentation cystoplasty or urinary diversion

- History of cystitis potentially due to pelvic radiation or Cytoxan

- Inability to speak and understand English

- Either treatment naïve for IC/BPS or on 3rd line or higher treatment per AUA
guidelines