Acupuncture First for IC/BPS

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366269
• Other study ID #: STUDY20240374
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Gabriella M Rustia, MD
• Phone: 216-202-0597
• Email: gabriella.rustia[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Syndrome

Intervention

Other:
• Acupuncture
traditional and electroacupuncture

Behavioral:
• Behavioral management
based on American urologic association guidelines

Other:
• Physical therapy
pelvic floor with biofeedback

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
David Sheyn

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Number of additional treatments used during study period	Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine	1 year post-treatment period
Secondary	Number of unscheduled interactions	Unscheduled interactions include any phone calls, messages, or unplanned visits	1 year post-treatment period