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

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

August 16, 2017

Study Completion Date

August 16, 2017

Conditions
Painful Bladder SyndromeInterstitial Cystitis
Interventions
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.

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."

Trial Locations (1)

60153

Loyola University Medical Center, Maywood

All Listed Sponsors
collaborator

Interstitial Cystitis Association (ICA)

OTHER

lead

Loyola University

OTHER

NCT02232282 - Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial | Biotech Hunter | Biotech Hunter