N/A
N=22
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Painful Bladder Syndrome · Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT02232282 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome — -2.08; -2.91 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- standard acupuncture treatment (Device); Control Sham/Minimal Acupuncture (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Loyola University
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome |
-2.08; -2.91 | — |
| SECONDARY Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom |
0; 0 | — |
| SECONDARY Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02232282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.