Clinical trial NCT06366269: Acupuncture First for IC/BPS
Official title: Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Pain Syndrome
Interstitial Cystitis
Keywords: acupuncture
bladder pain syndrome
interstitial cystitis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: O'Leary-Sant Interstitial Cystitis Index (OLSICI)
timeFrame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
measure: Short Form (SF-36)
timeFrame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
measure: Genitourinary Pain Index (GUPI)
timeFrame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
measure: Number of additional treatments used during study period
timeFrame: 1 year post-treatment period
measure: Number of unscheduled interactions
timeFrame: 1 year post-treatment period
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References: