Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 3:30 PM
Study NCT ID:
NCT06366269
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture First for IC/BPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "O'Leary-Sant Interstitial Cystitis Index (OLSICI)", 'timeFrame': 'Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)', 'description': 'Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)', 'description': 'Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse).'}, {'measure': 'Short Form (SF-36)', 'timeFrame': 'x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)', 'description': 'Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.'}, {'measure': 'Genitourinary Pain Index (GUPI)', 'timeFrame': 'Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)', 'description': 'Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.'}, {'measure': 'Number of additional treatments used during study period', 'timeFrame': '1 year post-treatment period', 'description': 'Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine'}, {'measure': 'Number of unscheduled interactions', 'timeFrame': '1 year post-treatment period', 'description': 'Unscheduled interactions include any phone calls, messages, or unplanned visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'bladder pain syndrome', 'interstitial cystitis'], 'conditions': ['Bladder Pain Syndrome', 'Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.\n\nParticipants will\n\n* complete surveys about their bladder pain symptoms\n* make behavioral changes that have been shown to improve bladder pain symptoms\n* attend six (6) weekly acupuncture sessions\n* attend six (6) weekly physical therapy sessions after finishing acupuncture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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"\n* Negative urine culture\n* Has completed cystoscopic evaluation for IC/BPS\n\nExclusion Criteria:\n\n* History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)\n* History of overactive bladder\n* History of bleeding disorder or are currently on chronic anti-coagulation\n* Post-void residual \\>100mL\n* 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\n* Prior bladder augmentation\n* Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy\n* Currently pregnant (if applicable, based on self-report)\n* Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)\n* Non-English speaking and reading'}, 'identificationModule': {'nctId': 'NCT06366269', 'briefTitle': 'Acupuncture First for IC/BPS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome', 'orgStudyIdInfo': {'id': 'STUDY20240374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain.\n\nThey will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy.', 'interventionNames': ['Other: Acupuncture', 'Behavioral: Behavioral management', 'Other: Physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Management', 'description': '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.', 'interventionNames': ['Behavioral: Behavioral management', 'Other: Physical therapy']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'traditional and electroacupuncture', 'armGroupLabels': ['Acupuncture']}, {'name': 'Behavioral management', 'type': 'BEHAVIORAL', 'description': 'based on American urologic association guidelines', 'armGroupLabels': ['Acupuncture', 'Behavioral Management']}, {'name': 'Physical therapy', 'type': 'OTHER', 'description': 'pelvic floor with biofeedback', 'armGroupLabels': ['Acupuncture', 'Behavioral Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriella Rustia, MD', 'role': 'CONTACT', 'email': 'gabriella.rustia@uhhospitals.org', 'phone': '216-202-0597'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Lydia Beard', 'role': 'CONTACT', 'email': 'Lydia.Beard@uhhospitals.org', 'phone': '216-844-1488'}, {'name': 'Gabriella Rustia, MD', 'role': 'CONTACT', 'email': 'gabriella.rustia@uhhospitals.org', 'phone': '216-202-0597'}], 'overallOfficials': [{'name': 'David Sheyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, UHMG', 'investigatorFullName': 'David Sheyn', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}