RECRUITING

Acupuncture First for IC/BPS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-21
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06366269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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"
  2. * Negative urine culture
  3. * Has completed cystoscopic evaluation for IC/BPS
  1. * History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
  2. * History of overactive bladder
  3. * History of bleeding disorder or are currently on chronic anti-coagulation
  4. * Post-void residual \>100mL
  5. * 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
  6. * Prior bladder augmentation
  7. * Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
  8. * Currently pregnant (if applicable, based on self-report)
  9. * Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
  10. * Non-English speaking and reading

Contacts and Locations

Study Contact

Gabriella M Rustia, MD
CONTACT
216-202-0597
gabriella.rustia@uhhospitals.org

Principal Investigator

David Sheyn, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • David Sheyn, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • acupuncture
  • bladder pain syndrome
  • interstitial cystitis

Additional Relevant MeSH Terms

  • Bladder Pain Syndrome
  • Interstitial Cystitis