Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT06729151
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
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': 'C000629279', 'term': 'onabotulinum toxin A'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual Function Index', 'timeFrame': 'Pre-treatment and 12 week post-treatment', 'description': '19-question survey encompassing several domains of sexual function in females'}], 'secondaryOutcomes': [{'measure': "O'Leary Sant Index", 'timeFrame': 'Pre-treatment and 12 week post-treatment', 'description': 'Screening tool for bladder pain syndrome'}, {'measure': 'Patient global impression of improvement (PGI-I)', 'timeFrame': '12 week post-treatment'}, {'measure': 'Patient global impression of severity (PGI-S)', 'timeFrame': 'Pre-treatment and 12 week post-treatment'}, {'measure': 'Pelvic pain and urgency/frequency symptom scale (PUF)', 'timeFrame': 'Pre-treatment and 12 week post-treatment'}, {'measure': 'Female sexual distress scale-revised (FSDS-R)', 'timeFrame': 'Pre-treatment and 12 week post-treatment'}, {'measure': 'Adverse events: UTI, urinary retention, additional treatment', 'timeFrame': '12 week post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Pain Syndrome', 'Female Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'Interstitial cystitis/bladder pain syndrome (IC/BPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC/BPS as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes". IC/BPS significantly impacts quality of life, with the individual domains of sexual function, anxiety and depression, sleep quality and work productivity being specifically affected. Significant sexual dysfunction in women with IC/BPS has been consistently demonstrated across multiple international studies, with a prevalence ranging from 68% to 91%. In fact, among all patients with lower urinary tract symptoms, patients with a diagnosis of IC/BPS had the highest levels of impaired sexual function, mostly due to dyspareunia. Recommended treatments for IC/BPS include dietary and behavioral modifications, oral medications, bladder instillations, bladder hydrodistension, intradetrusor injection of onabotulinumtoxinA and major surgery. Scant research exists on how treating IC/BPS affects sexual function. We are conducting a prospective cohort study to assess for improvement in sexual function following intravesical onabotulinumtoxinA injection versus conservative management for IC/BPS.\n\nThe study will consist of three groups: intradetrusor onabotulinumtoxinA injection, conservative management and age-matched, healthy controls. All patients aged 18 years and older presenting to the Walter Reed National Military Medical Center (WRNMMC) Urogynecology clinic who are given a diagnosis of IC/BPS and have an O\'Leary Sant index questionnaire scoring 13 or greater will be eligible for the study. The primary study outcome is change in the pre- and 12-week post-treatment Female Sexual Function Index (FSFI). The secondary outcomes will include changes in the pre- and post-treatment O\'Leary Sant index, Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S), Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), Visual analog pain scale and 24-hour bladder diary (number of daily voids, number of nightly voids, incontinence episode). Adverse events will be monitored, including urinary tract infection or need for urinary catheterization due to urinary retention within 12 weeks of start of treatment. The age-matched, healthy control group will complete only one set of questionnaires to serve as a baseline comparison to the IC/BPS groups. For between-groups comparisons, a sample size of 49 per group will have 80% power to detect a clinically important difference of 4 points if the standard deviation is 7 points, assuming a 5% two-sided significance level. We will therefore recruit 55 subjects per group to allow for approximately 10% attrition between the pre- and post-treatment assessments. This study will be powered to detect a difference between treatments groups, which has not yet been reported in the literature.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a clinical diagnosis of bladder pain syndrome and health controls without this diagnosis.', 'genderDescription': 'Female-identifying individuals', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female 18 years of age and older\n* For bladder pain syndrome participants: O'Leary Sant score 13 or greater\n* For healthy controls: O'Leary Sant score 12 or less\n* DEERS eligible (care provided by military health care system)\n\nExclusion Criteria:\n\n* Contraindications for bladder Botox\n* Current use of alternative treatment for bladder pain syndrome\n* Neurogenic bladder\n* Other urinary tract disease\n* Pelvic organ prolapse stage 3 or greater\n* Pregnancy or breastfeeding\n* Non-English speakers"}, 'identificationModule': {'nctId': 'NCT06729151', 'briefTitle': 'Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome', 'orgStudyIdInfo': {'id': 'WRNMMC-2024-0450'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': '49 healthy control patients complete the questionnaire packet once. No additional follow-up is completed.'}, {'label': 'Bladder pain syndrome treated with conservative management', 'description': '55 patients with bladder pain syndrome who choose treatment with conservative management complete pre-treatment and 12-week post-treatment questionnaires.', 'interventionNames': ['Behavioral: Conservative management (dietary and behavioral)']}, {'label': 'Bladder pain syndrome treated with bladder Botox', 'description': '55 patients with bladder pain syndrome who choose treatment with bladder Botox complete pre-treatment and 12-week post-treatment questionnaires.', 'interventionNames': ['Drug: Onabotulinum toxin A']}], 'interventions': [{'name': 'Onabotulinum toxin A', 'type': 'DRUG', 'description': 'Cystoscopic injection of Onabotulinum toxin A per standard clinic protocol.', 'armGroupLabels': ['Bladder pain syndrome treated with bladder Botox']}, {'name': 'Conservative management (dietary and behavioral)', 'type': 'BEHAVIORAL', 'description': 'Dietary and behavioral modifications consistent with recommendations from the American Urogynecological Society', 'armGroupLabels': ['Bladder pain syndrome treated with conservative management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20816', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Johnson, MD', 'role': 'CONTACT', 'email': 'emily.s.johnson26.vol@health.mil', 'phone': '443-492-9704'}], 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}