Clinical trial NCT02232282: Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Official title: Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Bladder Syndrome
Interstitial Cystitis
Keywords: Painful Bladder Syndrome
Interstitial Cystitis
Suprapubic Pain
Urinary Urgency
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Interstitial Cystitis Association (ICA)
First posted: 2014-09-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
timeFrame: 0 weeks, 6 weeks
Secondary outcomes:
measure: Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
timeFrame: 0 weeks, 6 weeks
measure: Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
timeFrame: 0 weeks, 12 weeks
Other outcomes:
measure: Change in Urinary Microbiome
timeFrame: 0 weeks, 6 weeks
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University Medical Center Dept of Urology
name: Larissa Bresler, MD
role: PRINCIPAL_INVESTIGATOR
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