Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06185218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Injection Site Maps & Intravesical Botulinum Toxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'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'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003556', 'term': 'Cystitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-25', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overactive bladder-V8 questionnaire will be used for efficacy of treatment.', 'timeFrame': 'Estimated 1 month for every patient after treatment.', 'description': 'The questionnaire contains 8 questions and every question may be scored between 0 and 5. Additionally, male gender get 2 points more. Therefore, a patient may be get between 0 and 42 points. More score means worse complaint.'}, {'measure': 'Urodynamics test will be assessed for efficacy of treatment.', 'timeFrame': 'Estimated 1 month for every patient after treatment.', 'description': 'Possible bladder contractions and residual volume will be measured in urodynamic testing to demonstrate effectiveness after treatment. The lack of pathological bladder contractions and normal residual urine mean better for patient and, show improving.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Botulinum Toxin', 'overactive bladder', 'interstitial cystitis'], 'conditions': ['Bladder Disease']}, 'descriptionModule': {'briefSummary': 'Botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. As far as is known, botulinum toxin injection sites have not been clearly defined. In this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Interstitial cystitis patients\n* Overactive bladder\n\nExclusion Criteria:\n\n* younger than 18 years'}, 'identificationModule': {'nctId': 'NCT06185218', 'briefTitle': 'Different Injection Site Maps & Intravesical Botulinum Toxin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'The Effect of Different Injection Site Maps on Intravesical Botulinum Toxin of Bladder', 'orgStudyIdInfo': {'id': 'KAEK/08.11.2023.530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MAP 1 (Posterior wall only)', 'description': 'Type 1 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal only posterior wall of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.', 'interventionNames': ['Other: Intravesical Botulinum Toxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAP 2 (Posterior wall + bilateral side walls)', 'description': 'Type 2 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal posterior wall + bilateral side walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.', 'interventionNames': ['Other: Intravesical Botulinum Toxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAP 3 (Non-trigonal all walls)', 'description': 'Type 3 map injection will be used to bladder in one session In this arm, Botulinum toxin type A injection will be apply to non-trigonal all walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.', 'interventionNames': ['Other: Intravesical Botulinum Toxin']}], 'interventions': [{'name': 'Intravesical Botulinum Toxin', 'type': 'OTHER', 'description': 'Botulinum Toxin injections will be made into the bladder.', 'armGroupLabels': ['MAP 1 (Posterior wall only)', 'MAP 2 (Posterior wall + bilateral side walls)', 'MAP 3 (Non-trigonal all walls)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}