Acupuncture First for IC/BPS

University Hospitals (UH)

Status: Enrolling

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Behavioral: Behavioral management; Other: Acupuncture; Other: Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06366269

STUDY20240374

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain. They will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy.

Treatment:

Other: Physical therapy

Other: Acupuncture

Behavioral: Behavioral management

Behavioral Management

Active Comparator group

Description:

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain for six (6) weeks before starting pelvic floor physical therapy.

Treatment:

Other: Physical therapy

Behavioral: Behavioral management