Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05945420
Status:
UNKNOWN
Last Update Posted:
2023-07-14
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adding Desmopressin to Tamsulosin for Treatment of BPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of symptoms and nocturia disappears or improve', 'timeFrame': 'Follow up for 6 months', 'description': 'Investigators will compare symptoms in the pretreatment period and follow up symptoms following treatment and record the outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nocturnal Polyurea in Patients With BPH']}, 'descriptionModule': {'briefSummary': 'In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea', 'detailedDescription': 'Investigators will give a group of patients tamsulosin and desmopressin and the other group will take tamsulosin and placepo and compare the outcome regarding symptoms of being prostatic hyperplasia especially nocturia and the effect on nocturnal polyurea in patients'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen with BPH Age more than 50years Patients with nocturia (2voids per night or More) Patients with nocturnal polyurea (urine volume More than 33%of urine allover the day) IPSS more than 12 Obstructed flow curve Post voiding residual less than 150\n\nExclusion Criteria:\n\n* men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer'}, 'identificationModule': {'nctId': 'NCT05945420', 'briefTitle': 'Adding Desmopressin to Tamsulosin for Treatment of BPH', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction', 'orgStudyIdInfo': {'id': 'MS.22.12.2245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Desmopressin arm', 'description': 'This arm will receive tamsulosin and desmopressin', 'interventionNames': ['Drug: Desmopressin Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'This arm will receive tamsulosin and placepo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desmopressin Acetate', 'type': 'DRUG', 'description': 'This arm will receive tamsulosin and desmopressin acetate daily a', 'armGroupLabels': ['Desmopressin arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'This arm will receive tamsulosin and placebo', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Outside U.S./Canada', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M. Shoma, PhD', 'role': 'CONTACT', 'email': 'ahmed.shoma@hotmail.com', 'phone': '502202222'}], 'facility': 'Urology and nephrology center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ahmed Azmy, Resident', 'role': 'CONTACT', 'email': 'dr.a.azmy93@gmail.com', 'phone': '+20 01010623936'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}