Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 8:50 AM
Study NCT ID:
NCT07429734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gabapentin Combined With Solifenacin for Non-neurogenic Overactive Bladder in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the total score and sub-scores of Overactive Bladder Symptom Score at follow-up visits.', 'timeFrame': '90 days', 'description': 'the study will assess the change in total score of overactive bladder symptom score (0-15) before and after recieving the treatment, as the minimum value (0) means better outcome, and maximum value (15) means worse outcome, also it will assess the change in the sub-scores such as : frequency : (0-2) , nocturia : (0-3) , urgency : (0-5) , urge incontinence : (0-5) where minimum values mean better outcome, and maximum values mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': '90 days', 'description': 'each patient will be followed up every 6 weeks during the 3 months period and surveyed for side effects. The number of patients who experienced side effects will be compared between the two groups and compare the number of patients who subsequently discontinued the treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'non-neurogenic', 'gabapentin', 'solifenacin', 'anticholinergic', 'Randomized Controlled Trial'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to compare the efficacy, safety and tolerability of solifenacin plus gabapentin versus solifenacin monotherapy for the treatment of women who are suffering from non-neurogenic ОАВ.\n\nThe main questions it aims to answer are:\n\nDoes combination of Solifenacin and Gabapentin affect the total score and sub-scores of OABSS in females with non-neurogenic ОАВ ? What medical problems do participants have when taking combination of Solifenacin and gabapentin ?', 'detailedDescription': 'Overactive bladder (OAB) syndrome is defined as a pathological condition characterized by urinary urgency, with or without incontinence, urinary frequency and nocturia in the absence of infection or other identifiable pathology. Global prevalence among women is estimated to be 21.9% with even higher prevalence among Egyptian women suggested to be around 57%. The pathophysiology of overactive bladder is incompletely understood. The underlying mechanism behind OAB symptoms is often detrusor overactivity (DOA), which has been linked to bladder ischemia and oxidative stress. Also, it is believed to be related to dysfunction within the nervous system, ranging from cortical and brainstem command centers to afferent signaling at the urothelial level. Also it is may be related to spontaneous activity in the detrusor muscle which can lead to involuntary contractions and urgency sensations, even without abnormal nerve stimulation. Antimuscarinic agents, such as solifenacin, are considered first-line pharmacological therapy after failure of conservative measures. However, the efficacy as a monotherapy is limited, and many patients experience persistent symptoms. Therefore, combination therapy using antimuscarinics and other agents such as B3 agonists has been proven to have more efficacy compared to monotheraрy.\n\nCurrently the focus of OAB treatment has changed to other bladder structures and mechanisms, such as modulation of bladder afferent outflow and urothelial signaling as targets for intervention. Gabapentin, a neuromodulator commonly used for neuropathic pain, has shown potential benefits in bladder hypersensitivity and sensory urgency due to its inhibitory effect on afferent C fiber activity, as these fibers demonstrate remarkable plasticity, which is involved in the micturition reflex to the spinal tract. Several randomized controlled trials and cohort studies have demonstrated some improvement in OAB symptoms with minimal adverse effects following gabapentin administration, supporting its potential use as a treatment for OAB. However, the vast majority of studies are done in neurogenic bladder, had relatively small sample sizes and modest treatment effects, and only very few studies are done in non-neurogenic bladders.\n\nIn this study, it is assumed that combination therapy of solifenacin and gabapentin may provide synergistic effects, improving both detrusor overactivity and sensory urgency, leading to better patient outcomes than solifenacin monotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overactive bladder symptom score (OABSS) \\> 5, urgency subscore ≥3, and urge incontinence score≥ 2.\n\nExclusion Criteria:\n\n* Active urinary tract infection\n* Neurogenic bladder\n* History of genitourinary malignancy\n* Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI\n* Any psychological or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT07429734', 'briefTitle': 'Efficacy of Gabapentin Combined With Solifenacin for Non-neurogenic Overactive Bladder in Women', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy and Tolerability of Solifenacin Combined With Gabapentin Versus Solifenacin Monotherapy for the Treatment of Non-neurogenic Overactive Bladder in Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS.25.11.3380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solifenacin Combined with Gabapentin', 'description': 'using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women', 'interventionNames': ['Drug: solifenacin combined with gabapentin']}, {'type': 'SHAM_COMPARATOR', 'label': 'solifenacin monotherapy', 'description': 'solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women', 'interventionNames': ['Drug: solifenacin monotherapy']}], 'interventions': [{'name': 'solifenacin combined with gabapentin', 'type': 'DRUG', 'description': 'using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women', 'armGroupLabels': ['Solifenacin Combined with Gabapentin']}, {'name': 'solifenacin monotherapy', 'type': 'DRUG', 'description': 'solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women', 'armGroupLabels': ['solifenacin monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'contacts': [{'name': 'Urology and Nephrology center - Mansoura University', 'role': 'CONTACT', 'email': 'unc@mans.edu.eg', 'phone': '+20502202222'}], 'facility': 'Urology and Nephrology center - Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohamed Elmaghawry, Resident', 'role': 'CONTACT', 'email': 'm7md.gano2016@gmail.com', 'phone': '+201125334957'}, {'name': 'Mohamed Hegazy, Lecturer', 'role': 'CONTACT', 'email': 'hegazym912@gmail.com'}], 'overallOfficials': [{'name': 'Urology and Nephrology center - Mansoura University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center - Mansoura University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of urology', 'investigatorFullName': 'Mohammed Hegazy', 'investigatorAffiliation': 'Mansoura University'}}}}