Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial

The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the
body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal
microbial communities. These microbiota are believed to be beneficial to human health,
facilitating efficient removal of improperly functioning immune cells and protecting the host
from pathogen infection13-15. The human bladder is a core component of the human urinary
tract. It is a hollow muscular organ lined with transitional epithelium, which functions as
the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal
space is also considered outside the body, it would seem reasonable that a urinary microbiota
would be present. Yet, the historic dogma has maintained that urine is "sterile," based on
culture-dependent methods of bacterial detection. This paradigm is shifting, however, based
on our newly published data noting the presence of a urinary microbiota in adult women
without clinical urinary tract infections16,17. Furthermore, we have recently discovered that
the microbiota of women with overactive bladder (specifically with associated urgency
incontinence) is distinguishable from the microbiota of women with stress urinary
incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the
urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome
dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This
work is limited by lack of correlative clinical symptomatology, small sample size and urinary
samples that may have been contaminated.

The investigators long term goal is to determine pelvic pain mechanisms that will inform
clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP.
The short term goal of this application is to determine the safety, tolerability and efficacy
of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the
urinary microbiome with acupuncture responders. Our approach will advance the understanding
of the contribution and consequences of peripheral pelvic nociception in IC/PBS.

Inclusion Criteria:

- Females, age 21 to 65 years

- Symptoms of urinary frequency, urgency and suprapubic/bladder pain for > 6 months

- Generally stable health

- An average bladder pain score of at least >3/10

Exclusion Criteria:

- Patients with pacemaker or other neurostimulator (gastric/spinal)

- History or current symptomatic urethral stricture, cystitis caused by tuberculosis,
radiation therapy or Cytoxan/cyclophosphamide therapy

- Prior augmentation cystoplasty or cystectomy

- Systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus,
Rheumatoid Arthritis, or Multiple Sclerosis)

- Systemic neuromuscular disease known to affect the lower urinary tract

- History of urogenital cancer (with the exception of minor skin cancer)

- Current or imminent planned pregnancy/recent delivery <6 months

- Current pelvic floor physical therapy

- Current use of opioid medications (short or long acting) for pain

- Abdominal or pelvic surgery within the last 6 months.