Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT07202832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Alkalinization for UTI in Women: RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019357', 'term': 'Potassium Citrate'}, {'id': 'D009582', 'term': 'Nitrofurantoin'}], 'ancestors': [{'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin', 'timeFrame': '7 days (Participants will be assessed at baseline, day 3, and day 7).', 'description': 'The primary outcome of this study is the reduction in urinary tract infection (UTI) symptoms, specifically dysuria (painful urination), urgency, and frequency, after 7 days of treatment with either Potassium Citrate or Nitrofurantoin. The severity of these symptoms will be measured using a standardized symptom questionnaire, where participants will rate the intensity of their symptoms at baseline (pre-treatment), day 3, and day 7. A reduction of ≥50% in symptom severity will be considered clinically significant. The results will be compared between the Potassium Citrate and Nitrofurantoin groups to determine which treatment is more effective in relieving UTI symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['UTI - Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether urinary alkalinization using potassium citrate can relieve symptoms and improve urine culture results in women aged 18 to 50 years with uncomplicated urinary tract infections (UTIs). The main questions it aims to answer are:\n\nDoes urinary alkalinization reduce UTI symptom scores by Day 7?\n\nDoes it lead to better urine culture results compared to antibiotic?\n\nResearchers will compare urinary alkalinization with potassium citrate to antibiotic to see if it provides more symptom relief and better microbiological outcomes.\n\nParticipants will:\n\nTake either potassium citrate or antibiotic\n\nBe assessed for symptoms and adverse events on Day 7\n\nProvide a urine sample for culture before and after treatment\n\nReport any return visits due to worsening symptoms or medication side effects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged ≥ 18 and ≤ 50.\n* Symptoms of uncomplicated UTI or cystitis; including urinary frequency, urgency and dysuria.\n* Positive urine culture of mid-urine urine.\n\nExclusion Criteria:\n\n* Post menopausal women.\n* Pregnancy.\n* Complicated UTIs, such as those requiring hospital admission, infections associated with fevers, those with urinary tract abnormalities, urinary tract calculi or urinary tract obstruction.\n* History of recurrent UTI.\n* Recent antibiotic use.\n* Acute pyelonephritis.\n* Immunocompromising conditions.\n* Chronic conditions such as interstitial cystitis, painful bladder syndrome, chronic pelvic pain syndrome.\n* Patients with CKD.\n* Patients with allergy to potassium citrate.'}, 'identificationModule': {'nctId': 'NCT07202832', 'acronym': 'UTI', 'briefTitle': 'Urine Alkalinization for UTI in Women: RCT', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy and Safety of Urine Alkalinization in Treatment of Uncomplicated Urinary Tract Infection in Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PreIRB-Assiut-URO002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium Citrate Treatment for UTI Symptom Relief', 'description': 'Participants in this arm will receive potassium citrate oral sachets twice daily for 7 days. The aim is to assess the effectiveness of potassium citrate in alleviating UTI symptoms such as dysuria and urgency in women with uncomplicated urinary tract infections. Participants will be monitored for symptom improvement, side effects, and any changes in urine culture.', 'interventionNames': ['Drug: potassium citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrofurantoin Antibiotic Treatment for UTI', 'description': 'Participants in this group will receive the antibiotic "Nitrofurantoin" for 7 days. This group serves as a control to compare the effectiveness of antibiotics against urinary alkalinization in treating symptoms of uncomplicated urinary tract infections (UTIs). The primary outcomes include symptom relief, changes in urine culture, and the occurrence of any side effects. This group\'s results will be compared with Arm 1 to determine if urinary alkalinization is equally or more effective than antibiotics in managing UTI symptoms.', 'interventionNames': ['Drug: Nitrofurantoin']}], 'interventions': [{'name': 'potassium citrate', 'type': 'DRUG', 'description': 'Potassium citrate is a medication used to alkalinize the urine, providing symptomatic relief of dysuria in patients with urinary tract infections (UTIs). In this study, participants in Arm 1 will receive potassium citrate for a period of 7 days. The treatment is aimed at reducing discomfort related to UTIs, such as burning sensations during urination and suprapubic pain. In addition to symptomatic relief, the intervention may also enhance bacterial phagocytosis and bacterial killing in the urine. Participants will be monitored for any side effects or adverse events during the treatment period.', 'armGroupLabels': ['Potassium Citrate Treatment for UTI Symptom Relief']}, {'name': 'Nitrofurantoin', 'type': 'DRUG', 'description': 'Nitrofurantoin is an antibiotic commonly used to treat uncomplicated urinary tract infections (UTIs). In this arm, participants will receive Nitrofurantoin for 7 days to treat their UTI. The primary objective is to evaluate its effectiveness in reducing UTI symptoms, such as dysuria, urgency, frequency, and suprapubic discomfort. This intervention will be compared with the urinary alkalinization therapy used in Arm 1. Researchers will also monitor changes in urine culture and any adverse events related to the antibiotic treatment.', 'armGroupLabels': ['Nitrofurantoin Antibiotic Treatment for UTI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Hamza Elhashamy, MBBCh', 'role': 'CONTACT', 'email': 'Hamza.Ahmed00099@med.aun.edu.eg', 'phone': '+201028635437'}, {'name': 'Abdelrahman Abdelshafi, MBBCh', 'role': 'CONTACT', 'email': 'abdulrahman.18313572@med.aun.edu.eg', 'phone': '+201123740500'}, {'name': 'Amr Darwish, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology Department, Faculty of Medicine, Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Hamza Elhashamy, MBBCh', 'role': 'CONTACT', 'email': 'Hamza.Ahmed00099@med.aun.edu.eg', 'phone': '+201028635437'}, {'name': 'Abdelrahman Abdelshafi, MBBCh', 'role': 'CONTACT', 'email': 'abdulrahman.18313572@med.aun.edu.eg', 'phone': '+201123740500'}], 'overallOfficials': [{'name': 'Amr Darwish, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology Department, Faculty of Medicine, Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Amr Esam Saad Mohamed Darwish', 'investigatorAffiliation': 'Assiut University'}}}}