Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:21 AM
Study NCT ID:
NCT07416968
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overactive Bladder Symptom Score percentage reduction', 'timeFrame': 'from enrollment to 12 weeks', 'description': 'self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms. Three points reduction in the total OABSS is determined as the minimal threshold for a meaningful change'}], 'secondaryOutcomes': [{'measure': 'Changes in frequnecy episodes in three-day voiding diary', 'timeFrame': 'from enrollment to follow up visits at 4,8 and 12 weeks', 'description': 'Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary'}, {'measure': 'changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score', 'timeFrame': 'from enrollment to follow up visits at 4,8 and 12 weeks', 'description': 'self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms'}, {'measure': 'changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)', 'timeFrame': 'All follow up visits at 4, 8, and 12 weeks', 'description': 'elf administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life'}, {'measure': 'Changes in number of nocturia episodes on three-day urinary diary', 'timeFrame': 'from enrollment to follow up visits at 4,8 and 12 weeks', 'description': 'changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary'}, {'measure': 'Changes in number of urgency episodes on three-day urinary diary', 'timeFrame': 'from enrollment to follow up visits at 4,8 and 12 weeks', 'description': 'Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary'}, {'measure': 'Changes in number of incontinence episodes on three-day voiding diary', 'timeFrame': 'from enrollment to follow up visits at 4,8 and 12 weeks', 'description': 'Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'OAB', 'Tadalafil', 'Solifenacin', 'Low dose tadalafil', 'Urgency', 'frequency', 'Urge Urinary Incontinence'], 'conditions': ['Overactive Bladder (OAB)', 'Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.\n\nWomen who join the study will be randomly placed into one of two groups:\n\nOne group will take tadalafil (5 mg), a medicine taken once a day.\n\nThe other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.\n\nThe study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.\n\nThe main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.\n\nWomen aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OAB symptoms persisting for ≥3 months\n* OAB Symptom Score (OABSS) \\> 5 and urgency sub-score of OABSS ≥ 2\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Active urinary tract infection.\n* Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI\n* Pelvic organ prolapse stage ≥II according to POP-Q system.\n* History of pelvic radiation.\n* History of neurosurgical interventions.\n* Pregnancy or breastfeeding.\n* Neuropathic diseases affecting the lower urinary tract.\n* History of genitourinary malignancy.\n* Post-void residual urine (PVR) \\> 150 ml.\n* Vesical or lower ureteric stones.\n* Uncontrolled diabetes mellitus (HbA1c \\> 7).\n* Any psychological or psychiatric disorders.\n* Contraindications or allergy to the used medications.\n* History of surgeries in the urinary bladder.\n* History of pelvic surgeries within 6 months.\n* Voiding dysfunctions.'}, 'identificationModule': {'nctId': 'NCT07416968', 'acronym': "WoMEN'S", 'briefTitle': 'Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': "Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)", 'orgStudyIdInfo': {'id': 'R.25.08.3317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1, Low dose Tadalafil group', 'description': 'Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks', 'interventionNames': ['Drug: Tadalafil 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Solifenacin Group', 'description': 'Participants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks', 'interventionNames': ['Drug: Solifenacin 5mg']}], 'interventions': [{'name': 'Tadalafil 5 mg', 'type': 'DRUG', 'description': 'Tadalafil 5 mg orally once daily for the duration of 12 weeks', 'armGroupLabels': ['Group 1, Low dose Tadalafil group']}, {'name': 'Solifenacin 5mg', 'type': 'DRUG', 'description': 'solifenacin succinate 5 mg orally once daily for the duration of 12 weeks', 'armGroupLabels': ['Group 2: Solifenacin Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'state': 'Al-Minūfiyyah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Barsim', 'role': 'CONTACT', 'email': 'ahmed.barsim@med.menofia.edu.eg', 'phone': '00201096024446'}], 'facility': 'Faculty of medicine, Menofia Univeristy', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}, {'city': 'Zagazig', 'state': 'Al-Sharqia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Kareem M Taha', 'role': 'CONTACT', 'email': 'K_m_t83@yahoo.com', 'phone': '00201220565349'}, {'name': 'Kareem M Taha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of medicine, Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Hegazy, MD of urology', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yahya H Elmorsy, MSc of Urology', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Urology and Nephrology Center, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Elkhashab', 'role': 'CONTACT', 'email': 'Dr_m_elkhashab@yahoo.com', 'phone': '01093131911'}, {'name': 'Mohammed Elkhashab', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Medhat Elkhashab', 'role': 'CONTACT', 'email': 'Dr_m_Elkhashab@yahoo.com', 'phone': '00201093131911'}], 'facility': 'faulty of medicine, Tanta Univeristy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Al Minyā', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Hussein Qassem', 'role': 'CONTACT', 'email': 'uromohamedhussein1987@gmail.com', 'phone': '00201033131812'}], 'facility': 'Faculty of medicine, minia university', 'geoPoint': {'lat': 29.74446, 'lon': 31.29917}}, {'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Wally Mahfouz', 'role': 'CONTACT', 'email': 'wallymahfouz77@gmail.com', 'phone': '00201119671666'}, {'name': 'Wally Mahfouz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of medicine, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Salaheldein', 'role': 'CONTACT', 'email': 'ahmed.salaheldien@aswan.edu.eg', 'phone': '00201100299002'}], 'facility': 'Faculty of medicine, Aswan university', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}, {'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan A Aboullela, Professor of Urology', 'role': 'CONTACT', 'email': 'h_a_aboulella@yahoo.com', 'phone': '00201063010777'}], 'facility': 'Faculty of Medicine - Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AlMoatasem Adel Albadawy', 'role': 'CONTACT', 'email': 'mo3tasemadel@gmail.com', 'phone': '00201148019617'}], 'facility': 'Faculty of Medicine - Banī Suwayf University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}, {'zip': '1181', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sheirf Mourad, Professor of Urology', 'role': 'CONTACT', 'email': 'msmourad@icloud.com', 'phone': '00201005355353'}, {'name': 'Sherif Mourad, professor of urology', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdelrahman nazmy Hatata', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '1211', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hussein Aly Hussein, Professor of Urology', 'role': 'CONTACT', 'email': 'Husseinaly@kasralainy.edu.eg', 'phone': '00201001422396'}], 'facility': 'Cairo University, faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa Abdelrazek', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, South Valley University', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}, {'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Mamdouh Abdelhamed', 'role': 'CONTACT', 'email': 'sharkawiahmed@yahoo.com', 'phone': '00201068056074'}], 'facility': 'Faculty of medicine, Sohag Univeristy', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohammed Hegazy, M.D of Urology', 'role': 'CONTACT', 'email': 'mhalem88@yahoo.com', 'phone': '+201028299216'}, {'name': 'Yahya H ElMorsy, MSc of Urology', 'role': 'CONTACT', 'email': 'hossam.yahya@yahoo.com', 'phone': '+201100311999'}], 'overallOfficials': [{'name': 'Ahmed A Shokeir, professor of urology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology & Nephrology Center, Masnoura university, Egypt'}, {'name': 'Sherif Mourad, Professor of Urology', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Ain Shams University', 'class': 'OTHER'}, {'name': 'Alexandria University', 'class': 'OTHER'}, {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, {'name': 'Tanta University', 'class': 'OTHER'}, {'name': 'Menoufia University', 'class': 'OTHER'}, {'name': 'Assiut University', 'class': 'OTHER'}, {'name': 'Sohag University', 'class': 'OTHER'}, {'name': 'South Valley University', 'class': 'OTHER'}, {'name': 'Beni-Suef University', 'class': 'OTHER'}, {'name': 'Minia University', 'class': 'OTHER'}, {'name': 'Aswan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}