NCT02232282
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
NA
COMPLETED
NCT02232282
INTERVENTIONAL
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.
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.
Painful Bladder Syndrome
Interstitial Cystitis
- TREATMENT
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- Type: DEVICE
- Name: standard acupuncture treatment
- 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.
- Arm Group Labels: Standard acupuncture treatment
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- Type: DEVICE
- Name: Control Sham/Minimal Acupuncture
- 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.
- Arm Group Labels: Minimal Acupuncture
- Loyola University