Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-04 @ 8:17 PM
Study NCT ID:
NCT06520267
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2024-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001437', 'term': 'Bacteriuria'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'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'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic BPH patients.The DNA of these microorganisms can be extracted and analyzed as part of the bacterial evaluation process.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-21', 'studyFirstSubmitDate': '2024-07-21', 'studyFirstSubmitQcDate': '2024-07-21', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of common pathogens and Antibiotic susceptibility testing', 'timeFrame': '4 weeks', 'description': 'Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH.'}], 'secondaryOutcomes': [{'measure': 'Severity of LUTS in patients with symptomatic BPH', 'timeFrame': '4 weeks', 'description': 'The study assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacteriuria', 'Benign Prostate Hyperplasia', 'Urinary Tract Infection'], 'conditions': ['Bacteriuria in Symptomatic Benign Prostate Hyperplasia', 'Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia', 'Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.', 'detailedDescription': 'This was a hospital-based prospective observational study.\n\nAll patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients was started on antibiotic therapy for a week based on antibiotic susceptibility testing.', 'genderDescription': 'Male patient with Benign Prostate Hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic BPH.\n\nExclusion Criteria:\n\n* Patients with indwelling catheters\n* Recent antibiotic use\n* Immunocompromised states (e.g., HIV, HCV)\n* Uncontrolled diabetes mellitus (Hemoglobin A1c \\> 7%)\n* Steroid therapy\n* Those who declined to provide consent'}, 'identificationModule': {'nctId': 'NCT06520267', 'acronym': 'BPH', 'briefTitle': 'Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.'}, 'officialTitle': 'Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Patients With Symptomatic Benign Prostatic Hyperplasia: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'IRC/1694/019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomatic BPH', 'description': 'All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.', 'interventionNames': ['Drug: Antibiotic therapy']}], 'interventions': [{'name': 'Antibiotic therapy', 'type': 'DRUG', 'otherNames': ['Antibiotics'], 'description': 'Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients were then prescribed antibiotics based on susceptibility testing for a duration of 1 week.', 'armGroupLabels': ['symptomatic BPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56700', 'city': 'Dharān', 'state': 'Koshi', 'country': 'Nepal', 'facility': 'BP Koirala Institute of Health Sciences', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be made available after publication of manuscript in the journal.', 'ipdSharing': 'YES', 'description': 'The Individual Participant Data (IPD) to be shared from this study will encompass demographic details (age, sex), clinical characteristics (severity and duration of lower urinary tract symptoms, baseline IPSS scores), microbiological findings (bacterial species isolated from urine cultures, antibiotic sensitivity patterns), treatment information (antibiotic regimen and duration), and clinical outcomes (post-treatment IPSS scores, follow-up urine culture results). This comprehensive dataset will facilitate in-depth analysis of the impact of antibiotic therapy on symptom relief and bacteriuria in patients with symptomatic Benign Prostatic Hyperplasia (BPH), thereby supporting future research and enhancing clinical management strategies.', 'accessCriteria': 'Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicpal Investigator', 'investigatorFullName': 'Ishwor Thapaliya', 'investigatorAffiliation': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.'}}}}