Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT06197295
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2023-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'C520025', 'term': 'mirabegron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short form of Urinary Distress Inventory (UDI-6)', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.'}, {'measure': 'Short form of Incontinence Impact Questionnaire (IIQ-7)', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships \\& emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.'}, {'measure': 'Overactive Bladder Symptom Score (OABSS)', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.'}], 'secondaryOutcomes': [{'measure': 'Episodes of daily micturition', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'Patients report daily lower urinary tract symptoms episodes'}, {'measure': 'Episodes of daily urgency', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'Patients report daily lower urinary tract symptoms episodes'}, {'measure': 'Episodes of daily incontinence', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'Patients report daily lower urinary tract symptoms episodes'}, {'measure': 'Episodes of daily nocturia', 'timeFrame': 'Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment', 'description': 'Patients report daily lower urinary tract symptoms episodes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Detrusor overactivity', 'Combined pharmacotherapy', 'Estrogens', 'Effectiveness'], 'conditions': ['Urinary Bladder, Overactive', 'Effect of Drug']}, 'referencesModule': {'references': [{'pmid': '31039103', 'type': 'BACKGROUND', 'citation': 'Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.'}, {'pmid': '30644570', 'type': 'BACKGROUND', 'citation': 'Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.'}, {'pmid': '15453881', 'type': 'BACKGROUND', 'citation': 'Cardozo L, Lose G, McClish D, Versi E. A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder. Acta Obstet Gynecol Scand. 2004 Oct;83(10):892-7. doi: 10.1111/j.0001-6349.2004.00581.x.'}]}, 'descriptionModule': {'briefSummary': 'To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.', 'detailedDescription': 'Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'The study focus on female detrusor overactivity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study.\n\nExclusion Criteria:\n\n* Postvoid urine retention before treatment\n* Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension\n* Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.\n* Women who were on hormone replacement therapy within 3 months were also excluded from the study'}, 'identificationModule': {'nctId': 'NCT06197295', 'briefTitle': 'Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity', 'orgStudyIdInfo': {'id': '22MMHIS039e-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solifenacin with vaginal estrogen cream', 'description': 'Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.', 'interventionNames': ['Drug: Solifenacin with vaginal estrogen cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination pharmacotherapy', 'description': 'Combined solifenacin 5mg and mirabegron 25mg once per day.', 'interventionNames': ['Drug: Combination pharmacotherapy']}], 'interventions': [{'name': 'Solifenacin with vaginal estrogen cream', 'type': 'DRUG', 'otherNames': ['Premarin'], 'description': 'Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg', 'armGroupLabels': ['Solifenacin with vaginal estrogen cream']}, {'name': 'Combination pharmacotherapy', 'type': 'DRUG', 'otherNames': ['Vesicare and Betmiga'], 'description': 'Solifenacin 5mg and Mirabegron 25mg', 'armGroupLabels': ['Combination pharmacotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jiun Chyi Hwang, MD', 'role': 'CONTACT', 'email': 'jiun1989@gmail.com', 'phone': '+886-2-2543-3535'}], 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hui-Hsuan Lau, MD', 'role': 'CONTACT', 'email': 'huihsuan1220@gmail.com', 'phone': '+886-2-25433535'}], 'overallOfficials': [{'name': 'Hui-Hsuan Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of urogynecology, Associate Professor', 'investigatorFullName': 'Hui-Hsuan Lau, MD', 'investigatorAffiliation': 'Mackay Memorial Hospital'}}}}