Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Painful Bladder Syndrome, Interstitial Cystitis
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
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
Sham Comparator
Active Comparator
Minimal Acupuncture
Standard acupuncture treatment
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.