Acupuncture First for IC/BPS

NCT06366269 | Recruiting

• 1 other identifier: STUDY20240374
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Bladder Pain Syndrome; Interstitial Cystitis

Keywords

acupuncture; bladder pain syndrome; interstitial cystitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Global Impression of Improvement (PGI-I)

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

• Short Form (SF-36)

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

• Genitourinary Pain Index (GUPI)

  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

  1 year post-treatment period

• Number of unscheduled interactions

  1 year post-treatment period

Study Arms (2)

Acupuncture

EXPERIMENTAL

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; Behavioral: Behavioral management; Other: Physical therapy

Behavioral Management

ACTIVE COMPARATOR

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; Other: Physical therapy

Interventions

Acupuncture OTHER

traditional and electroacupuncture

Acupuncture

Behavioral management BEHAVIORAL

based on American urologic association guidelines

Acupuncture; Behavioral Management

Physical therapy OTHER

pelvic floor with biofeedback

Acupuncture; Behavioral Management

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Acupuncture Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Abou Zeki

CONTACT

216-286-0603; Jessica.AbouZeki@UHhospitals.org

Gabriella Rustia, MD

CONTACT

216-202-0597; gabriella.rustia@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, UHMG

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)