Acupuncture First for IC/BPS

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

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 Overview

• Status: Recruiting
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Intervention / Treatment: Other: Acupuncture; Behavioral: Behavioral management; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriella Rustia, MD; Phone Number: 216-202-0597; Email: gabriella.rustia@uhhospitals.org
• Study Contact Backup: Name: Jessica Abou Zeki; Phone Number: 216-286-0603; Email: Jessica.AbouZeki@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Gabriella Rustia, MD; Phone Number: 216-202-0597; Email: gabriella.rustia@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; 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.	Other: Acupuncture; traditional and electroacupuncture; Behavioral: Behavioral management; based on American urologic association guidelines; Other: Physical therapy; pelvic floor with biofeedback
Active Comparator: Behavioral Management; 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.	Behavioral: Behavioral management; based on American urologic association guidelines; Other: Physical therapy; pelvic floor with biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
O'Leary-Sant Interstitial Cystitis Index (OLSICI)	Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.	Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of additional treatments used during study period	Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine	1 year post-treatment period
Number of unscheduled interactions	Unscheduled interactions include any phone calls, messages, or unplanned visits	1 year post-treatment period
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).	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.	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.	Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; interstitial cystitis; bladder pain syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Therapeutics; Complementary Therapies; Rehabilitation; Acupuncture Therapy; Physical Therapy Modalities
• Other Study ID Numbers: STUDY20240374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No