Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 2:43 AM
Study NCT ID:
NCT03513250
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2018-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-04-29', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).', 'timeFrame': 'one hour post-operatively.', 'description': 'the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").\n\nCRBD will be defined as the presence of an urge to void or suprapubic discomfort with an NRS score of ≥3.'}], 'secondaryOutcomes': [{'measure': 'catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).', 'timeFrame': 'two hours postopeatively.', 'description': 'the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").'}, {'measure': 'catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).', 'timeFrame': 'six hours postoperatively.', 'description': 'numerical rating scale.'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': '6 hours postoperative', 'description': 'Postoperative nausea and vomiting'}, {'measure': 'dry mouth', 'timeFrame': '6 hours postoperative', 'description': 'the patient says"My mouth is dry"'}, {'measure': 'facial flushing', 'timeFrame': '6 hours postoperative', 'description': 'My face is hot.'}, {'measure': 'painkiller', 'timeFrame': 'Up to 6 hours after study drug administration', 'description': 'the need for rescue analgesics'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheter Related Bladder Discomfort']}, 'descriptionModule': {'briefSummary': 'a prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.', 'detailedDescription': 'The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean section may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with an indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD.\n\nMore preventive than therapeutic drugs for CRBD should be investigated to improve patient comfort in all surgery patients with a urinary catheter.\n\nA prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.\n\nExclusion Criteria:\n\n* • Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks).\n\n * Contraindications for general anesthesia.\n * Maternal bladder, urethral and renal disorders causing irritating voiding problems such as dysuria, urge and stress incontinence.\n * Obstructive voiding symptoms like incomplete emptying, straining and voiding difficulty before surgery.\n * Overactive bladder (frequency: more than three times during the night or more than eight times in 24 h).\n * Morbid obesity.\n * Disturbances of the central nervous system (epilepsy, patients receiving MAO inhibitor).\n * Hypertensive disorders and/ or systemic disease requiring particular patient care (for example, cardiac disease, nephritic disorders).\n * Chronic analgesic abuse.\n * Hepatic or psychiatric disease will be excluded from the study.\n * A history of hypersensitivity or contraindication to hyoscine-n-butylbromide.'}, 'identificationModule': {'nctId': 'NCT03513250', 'briefTitle': 'Efficacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'bladder discomfort'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyoscine-n-butylbromide group', 'description': 'one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.', 'interventionNames': ['Drug: hyoscine-n-butylbromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section.', 'interventionNames': ['Drug: control group']}], 'interventions': [{'name': 'hyoscine-n-butylbromide', 'type': 'DRUG', 'description': 'one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.', 'armGroupLabels': ['hyoscine-n-butylbromide group']}, {'name': 'control group', 'type': 'DRUG', 'otherNames': ['saline group'], 'description': 'an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12944', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Ahmed Ashour', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'AHMED SAMY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in obstetrics and gynecology', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}