Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05130918
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2021-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Mictalase® After ThuLEP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IPSS', 'timeFrame': '15 and 30 days post-operation', 'description': 'evaluation of effects of the suppository on irritative symptoms as assessed by eventual reduction in International Prostate Symptom Score (IPSS).\n\nSpecifically, % reduction in absolute value of IPSS will be compared between the groups.'}, {'measure': 'QoL', 'timeFrame': '15 and 30 days post-operation', 'description': 'evaluation of effects of the suppository on Quality of life as assessed by eventual reduction in Quality of Life score.\n\nSpecifically, % reduction in absolute value of QoL will be compared between the groups.'}], 'secondaryOutcomes': [{'measure': 'Urinary Infection', 'timeFrame': '15 and 30 days post-operation', 'description': 'evaluation of effects of the suppository on occurrence of urinary infections after thulium laser enucleation of prostate as assessed by urine culture.\n\nSpecifically, the rates of positive urine culture will be compared between the groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['benign prostatic hyperplasia', 'BPH', 'laser enucleation', 'ThuLEP', 'LUTS', 'urinary tract infections'], 'conditions': ['BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '35151280', 'type': 'DERIVED', 'citation': 'Bertolo R, Cipriani C, Vittori M, Carilli M, Maiorino F, Iacovelli V, Ganini C, Antonucci M, Signoretti M, Petta F, Panei M, Bove P. The efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase(R)) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate: a single-center, randomized, controlled, open label, phase III study. BMC Urol. 2022 Feb 12;22(1):19. doi: 10.1186/s12894-022-00974-0.'}]}, 'descriptionModule': {'briefSummary': 'In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The trial is conducted on a population of males who underwent surgical intervention for benign prostatic hyperplasia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.\n\nExclusion Criteria:\n\n* patients with history of prostatitis,\n* patients with history of neurogenic detrusor overactivity (as determined after urodynamic observation),\n* patients diagnosed with prostate cancer,\n* patients who underwent previous surgeries of the lower urinary tract,\n* patients with indwelling catheter,\n* patients with history of nephrolithiasis,\n* patients with known or suspected hypersensitivity to Phenolmicin P3 and/or Bosexil\n* patients experiencing occurrence of severe intraoperative complications.'}, 'identificationModule': {'nctId': 'NCT05130918', 'briefTitle': 'Efficacy of Mictalase® After ThuLEP', 'organization': {'class': 'OTHER', 'fullName': 'San Carlo di Nancy Hospital'}, 'officialTitle': 'The Efficacy of a Suppository Based on Phenolmicin P3 and Bosexil in Control of Irritative Symptoms in Patients Undergoing Thulium Laser Enucleation of Prostate: a Single-center, Randomized, Controlled, Open Label, Phase III Study', 'orgStudyIdInfo': {'id': 'Mictalase'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenolmicin P3 and Bosexil', 'description': 'Group in which patients were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days after thulium laser enucleation of prostate was performed.', 'interventionNames': ['Device: Phenolmicin P3 and Bosexil suppository']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.'}], 'interventions': [{'name': 'Phenolmicin P3 and Bosexil suppository', 'type': 'DEVICE', 'otherNames': ['Mictalase'], 'description': 'The suppository we herein investigated includes different active principles, namely: Bosexil®, that is a vegetal extract derived from the resin of the Boswellia serrata, a plant native to India. It has already been published that the Boswellic acids contained show anti-inflammatory and antioxidant properties in a variety of inflammatory diseases whose physio-pathological pathways are shared with those of prostatitis; phenolmicin P3 is a polyphenolic extract derived from beehive propolis, that also demonstrated anti-inflammatory and antioxidant properties in preclinical reports. It has also been reported to have the ability to create a microenvironment hostile to the reproduction of pathogenic bacteria.', 'armGroupLabels': ['Phenolmicin P3 and Bosexil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'San Carlo di Nancy Hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Pierluigi Bove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Carlo di Nancy Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The analysis of the data obtained within the trial will be subject of scientific publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Carlo di Nancy Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}