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

Primary Purpose

Painful Bladder Syndrome, Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard acupuncture treatment
Control Sham/Minimal Acupuncture
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Bladder Syndrome focused on measuring Painful Bladder Syndrome, Interstitial Cystitis, Suprapubic Pain, Urinary Urgency

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Minimal Acupuncture

Standard acupuncture treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
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.

Secondary Outcome Measures

Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
The total number of adverse events experienced by women receiving acupuncture

Full Information

First Posted
August 29, 2014
Last Updated
March 17, 2022
Sponsor
Loyola University
Collaborators
Interstitial Cystitis Association (ICA)
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1. Study Identification

Unique Protocol Identification Number
NCT02232282
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
Collaborators
Interstitial Cystitis Association (ICA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Bladder Syndrome, Interstitial Cystitis
Keywords
Painful Bladder Syndrome, Interstitial Cystitis, Suprapubic Pain, Urinary Urgency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal Acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Standard acupuncture treatment
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
standard acupuncture treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Sham/Minimal Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
Description
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.
Time Frame
0 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
Description
The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
Time Frame
0 weeks, 6 weeks
Title
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
Description
The total number of adverse events experienced by women receiving acupuncture
Time Frame
0 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Urinary Microbiome
Description
A change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.
Time Frame
0 weeks, 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa Bresler, MD
Organizational Affiliation
Loyola University Medical Center Dept of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial

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