Acupuncture First for IC/BPS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Other interventiontraditional and electroacupuncture
Behavioral management
Behavioralbased on American urologic association guidelines
Physical therapy
Other interventionpelvic floor with biofeedback
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: AcupunctureExperimental treatment 3 interventions
Group B: Behavioral ManagementActive comparator 2 interventions
Trial outcomes
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.
Time frame
Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)Secondary outcomes
1
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).
Time frame
x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)2
Short Form (SF-36)
Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.
Time frame
x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)3
Genitourinary Pain Index (GUPI)
Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.
Time frame
Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)4
Number of additional treatments used during study period
Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine
Time frame
1 year post-treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov