Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Condition: Painful Bladder Syndrome; Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Pain
Study type: Interventional

Summary: 
      The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder
      Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture
      responders will have a differential urinary microbiome.
    

Detailed description: 
      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.
    

Intervention name(s): standard acupuncture treatment; Control Sham/Minimal Acupuncture
Intervention type(s): Device; Device
Intervention description(s): A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.; Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Painful Bladder Syndrome; Interstitial Cystitis; Suprapubic Pain; Urinary Urgency