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Recruiting NCT06366269

Acupuncture First for IC/BPS

No phase Interventional Bladder Pain Syndrome Interstitial Cystitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture, Behavioral management, Physical therapy.
Who it may be relevant to
Registry conditions: Bladder Pain Syndrome, Interstitial Cystitis. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome

Overview

The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is: Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. Participants will * complete surveys about their bladder pain symptoms * make behavioral changes that have been shown to improve bladder pain symptoms * attend six (6) weekly acupuncture sessions * attend six (6) weekly physical therapy sessions after finishing acupuncture

Interventions

  • Other Acupuncture
    traditional and electroacupuncture
  • Behavioral Behavioral management
    based on American urologic association guidelines
  • Other Physical therapy
    pelvic floor with biofeedback

Primary outcome measures

  • O'Leary-Sant Interstitial Cystitis Index (OLSICI) [Time frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)]
Secondary outcome measures (5)
  • Patient Global Impression of Improvement (PGI-I) [Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)]
  • Short Form (SF-36) [Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)]
  • Genitourinary Pain Index (GUPI) [Time frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)]
  • Number of additional treatments used during study period [Time frame: 1 year post-treatment period]
  • Number of unscheduled interactions [Time frame: 1 year post-treatment period]

Eligibility criteria

Inclusion criteria

  • Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladder pain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause"
  • Negative urine culture
  • Has completed cystoscopic evaluation for IC/BPS

Exclusion criteria

  • History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
  • History of overactive bladder
  • History of bleeding disorder or are currently on chronic anti-coagulation
  • Post-void residual >100mL
  • Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox
  • Prior bladder augmentation
  • Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
  • Currently pregnant (if applicable, based on self-report)
  • Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
  • Non-English speaking and reading

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Hospitals — Cleveland

Identifiers

NCT: NCT06366269 · STUDY20240374

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗