Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05878951
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.', 'timeFrame': '12 months', 'description': 'Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.'}], 'secondaryOutcomes': [{'measure': 'Difference in safety/ adverse effects', 'timeFrame': '90 days', 'description': 'Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.'}, {'measure': 'Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)', 'timeFrame': '6 months', 'description': 'Identifying symptom resolution at different time points (1 month, 3 months, 6 months)'}, {'measure': 'Difference in efficacy endpoints (3-month clinic/telephone follow-up)', 'timeFrame': '3 months', 'description': 'Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Overactive Bladder Syndrome', 'Overactive Bladder', 'Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.', 'detailedDescription': 'Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men experiencing overactive bladder symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males 18 -89 undergoing HoLEP\n* Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence\n* Willing to sign the Informed Consent Form\n* Able to read, understand, and complete patient questionnaires.\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to OnabotulinumtoxinA injections\n* Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP\n* Anticipated need for perineal urethrostomy at the time of HoLEP\n* Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy\n* Patients who lack decisional capacity\n* Active urinary tract infection'}, 'identificationModule': {'nctId': 'NCT05878951', 'briefTitle': 'Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms', 'orgStudyIdInfo': {'id': 'STU00218130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-detrusor OnabotulinumtoxinA Injection', 'description': 'Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.', 'interventionNames': ['Drug: OnabotulinumtoxinA']}, {'type': 'NO_INTERVENTION', 'label': 'No intra-detrusor OnabotulinumtoxinA Injection', 'description': 'Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.'}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'Intra-detrusor OnabotulinumtoxinA is commonly known as botox', 'armGroupLabels': ['Intra-detrusor OnabotulinumtoxinA Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyssa McDonald', 'role': 'CONTACT'}], 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Alyssa McDonald', 'role': 'CONTACT', 'email': 'Alyssa.McDonald@northwestern.edu', 'phone': '312-695-8146'}, {'name': 'Allaa Fadl-Alla', 'role': 'CONTACT', 'email': 'Allaa.Fadlalla@northwestern.edu', 'phone': '312-695-8146'}], 'overallOfficials': [{'name': 'Amy Krambeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Amy Krambeck', 'investigatorAffiliation': 'Northwestern University'}}}}