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

March 17, 2022 updated by: Larissa Bresler, Loyola University

Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
Time Frame: 0 weeks, 6 weeks
Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
0 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
Time Frame: 0 weeks, 6 weeks
The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
0 weeks, 6 weeks
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
Time Frame: 0 weeks, 12 weeks
The total number of adverse events experienced by women receiving acupuncture
0 weeks, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary Microbiome
Time Frame: 0 weeks, 6 weeks
A change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.
0 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Interstitial Cystitis Association (ICA)

Investigators

  • Principal Investigator: Larissa Bresler, MD, Loyola University Medical Center Dept of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

August 16, 2017

Study Completion (Actual)

August 16, 2017

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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