Status:
COMPLETED
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Interstitial Cystitis Association (ICA)
Conditions:
Painful Bladder Syndrome
Interstitial Cystitis
Eligibility:
FEMALE
21-65 years
Phase:
NA
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 wi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02232282
Start Date
October 1 2014
End Date
August 16 2017
Last Update
April 14 2022
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153