Acupuncture First for IC/BPS

Not Applicable

Recruiting

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis
• Interventions: Other: Acupuncture; Behavioral: Behavioral management; Other: Physical therapy

• Registration Number: NCT06366269
• Lead Sponsor: University Hospitals Cleveland Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Study Start: 2025-01-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	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.
Acupuncture	Physical therapy	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.
Behavioral Management	Physical therapy	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 Management	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.
Acupuncture	Behavioral management	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Genitourinary Pain Index (GUPI)	Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)	Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.
Number of additional treatments used during study period	1 year post-treatment period	Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine
Short Form (SF-36)	x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)	Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.
Patient Global Impression of Improvement (PGI-I)	x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)	Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse).
Number of unscheduled interactions	1 year post-treatment period	Unscheduled interactions include any phone calls, messages, or unplanned visits

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States