Acupuncture First for IC/BPS

University Hospitals Cleveland Medical Center34 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bladder Pain Syndrome Interstitial Cystitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

O'Leary-Sant Interstitial Cystitis Index (OLSICI)

Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.

Time frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)

Secondary Outcomes

Patient Global Impression of Improvement (PGI-I)

Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse).

Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)

Short Form (SF-36)

Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.

Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)

Genitourinary Pain Index (GUPI)

Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.

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

Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine

Time frame: 1 year post-treatment period

Number of unscheduled interactions

Unscheduled interactions include any phone calls, messages, or unplanned visits