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

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ClinicalTrials.gov Identifier: NCT02232282
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Interstitial Cystitis Association (ICA)
Information provided by (Responsible Party):
Larissa Bresler, Loyola University

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date February 1, 2018
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
Acupuncture in women with IC/PBS. [ Time Frame: 12 weeks ]
True acupuncture treatment will be effective in the treatment of pain in women with IC/PBS compared with sham/minimal treatment. Improvement on the Brief Pain Inventory of 2 points will reflect change from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02232282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Official Title  ICMJE Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Painful Bladder Syndrome
  • Interstitial Cystitis
Intervention  ICMJE
  • Device: standard acupuncture treatment
    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.
  • Device: Control Sham/Minimal Acupuncture
    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.
Study Arms  ICMJE
  • Sham Comparator: Minimal Acupuncture
    Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. 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.
    Intervention: Device: Control Sham/Minimal Acupuncture
  • Active Comparator: Standard acupuncture treatment
    Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. 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.
    Intervention: Device: standard acupuncture treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2014)
30
Actual Study Completion Date  ICMJE August 16, 2017
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232282
Other Study ID Numbers  ICMJE 206129
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Larissa Bresler, Loyola University
Study Sponsor  ICMJE Loyola University
Collaborators  ICMJE Interstitial Cystitis Association (ICA)
Investigators  ICMJE
Principal Investigator: Larissa Bresler, MD Loyola University Medical Center Dept of Urology
PRS Account Loyola University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP