Acupuncture for treating bladder pain syndrome in women
Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
This study is testing if acupuncture, along with some behavior changes, can help women with bladder pain syndrome feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06366269 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of acupuncture combined with behavioral management in treating women suffering from bladder pain syndrome, also known as interstitial cystitis, who have not received prior treatments. Participants will engage in six weeks of behavioral management and attend weekly acupuncture sessions, followed by physical therapy. The primary focus is to determine if acupuncture can significantly improve pain symptoms as measured by the Interstitial Cystitis Index. Surveys will be completed to assess changes in bladder pain symptoms throughout the study.
Who should consider this trial
Good fit: Ideal candidates are women who meet the criteria for interstitial cystitis/bladder pain syndrome and have not previously undergone treatments such as acupuncture or pelvic floor physical therapy.
Not a fit: Patients with a history of recurrent urinary tract infections or those who have previously received specific bladder treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for women suffering from bladder pain syndrome.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific combination of acupuncture and behavioral management for bladder pain syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Jessica Abou Zeki
- Email: Jessica.AbouZeki@UHhospitals.org
- Phone: 216-286-0603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.