Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04561505
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2020-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cost analysis', 'timeFrame': '3 days postoperative', 'description': 'comparing cost analysis for each patient in both groups as regards running cost including laser fiber or monopolar loop, irrigation fluid and cost of hospital stay.'}, {'measure': 'complications', 'timeFrame': '1 year', 'description': 'assessing intraoperative, early postoperative and late postoperative complications in both groups'}], 'primaryOutcomes': [{'measure': 'the international prostate symptom score (IPSS)', 'timeFrame': '1 year', 'description': 'assessing the improvement of IPSS'}, {'measure': 'maximum urine flow rate (Qmax)', 'timeFrame': '1 year', 'description': 'assessing the improvement of Qmax'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'immediately postoperative', 'description': 'estimating the operative time in both groups in minutes'}, {'measure': 'resected volume', 'timeFrame': 'immediately postoperative', 'description': 'measuring the resected volume of prostate after each operation'}, {'measure': 'postoperative drop in hemaoglobin level', 'timeFrame': '1 day postoperative', 'description': 'comparing postoperative hemoglobin level with preoperative level in both groups'}, {'measure': 'postoperative drop in sodium level', 'timeFrame': '1 day postoperative', 'description': 'comparing postoperative sodium level with preoperative level in both groups'}, {'measure': 'postoperative catheterization time', 'timeFrame': '4 days postoperative', 'description': 'assessing postoperative catheterization time in both groups'}, {'measure': 'duration of hospital stay', 'timeFrame': '3 days postoperative', 'description': 'assessing duration of hospital stay in both groups'}, {'measure': 'postvoiding residual urine volume', 'timeFrame': '1 year', 'description': 'assessing postvoiding residual urine volume in both groups'}, {'measure': 'ultrasound assessed prostate volume', 'timeFrame': '1 year', 'description': 'comparing ultrasound assessed prostate volume in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate', 'transurethral resection of prostate', 'HoLEP'], 'conditions': ['Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '8918007', 'type': 'BACKGROUND', 'citation': 'Magoha GA. Medical management of benign prostatic hyperplasia: a review. East Afr Med J. 1996 Jul;73(7):453-6.'}, {'pmid': '23541338', 'type': 'BACKGROUND', 'citation': "Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13."}, {'pmid': '21883855', 'type': 'BACKGROUND', 'citation': 'Biester K, Skipka G, Jahn R, Buchberger B, Rohde V, Lange S. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int. 2012 Mar;109(5):722-30. doi: 10.1111/j.1464-410X.2011.10512.x. Epub 2011 Aug 22.'}, {'pmid': '22033173', 'type': 'BACKGROUND', 'citation': 'Bach T, Muschter R, Sroka R, Gravas S, Skolarikos A, Herrmann TR, Bayer T, Knoll T, Abbou CC, Janetschek G, Bachmann A, Rassweiler JJ. Laser treatment of benign prostatic obstruction: basics and physical differences. Eur Urol. 2012 Feb;61(2):317-25. doi: 10.1016/j.eururo.2011.10.009. Epub 2011 Oct 21.'}, {'pmid': '16469429', 'type': 'BACKGROUND', 'citation': 'Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.'}, {'pmid': '27564287', 'type': 'BACKGROUND', 'citation': 'Pearce SM, Pariser JJ, Malik RD, Famakinwa OJ, Chung DE. Outcomes following Thulium vapoenucleation of large prostates. Int Braz J Urol. 2016 Jul-Aug;42(4):757-65. doi: 10.1590/S1677-5538.IBJU.2015.0424.'}, {'pmid': '18499180', 'type': 'BACKGROUND', 'citation': 'Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol. 2008 Jul;180(1):241-5; discussion 245. doi: 10.1016/j.juro.2008.03.039. Epub 2008 May 21.'}, {'pmid': '16314033', 'type': 'BACKGROUND', 'citation': 'Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. Eur Urol. 2006 Jan;49(1):87-91. doi: 10.1016/j.eururo.2005.08.015. Epub 2005 Nov 2.'}, {'pmid': '15072628', 'type': 'BACKGROUND', 'citation': 'Kuntz RM, Lehrich K, Ahyai S. Does perioperative outcome of transurethral holmium laser enucleation of the prostate depend on prostate size? J Endourol. 2004 Mar;18(2):183-8. doi: 10.1089/089277904322959842.'}, {'pmid': '16632179', 'type': 'BACKGROUND', 'citation': 'Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol. 2006 Jun;49(6):961-9. doi: 10.1016/j.eururo.2006.03.028. Epub 2006 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.', 'detailedDescription': "Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population.\n\nThe symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.\n\nLower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial.\n\nLUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom.\n\nMultiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size.\n\nThese complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome.\n\nClearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure.\n\nModern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation.\n\nBecause of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005.\n\nHolmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay.\n\nHoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH.\n\nFor a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard.\n\nTo our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country.\n\nOur study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'males only have prostate that will need surgical management of BPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate volume less than 80 ml\n* high IPSS more than 19 affecting quality of life\n* recurrent urinary retention with failure of medical treatment\n* recurrent urinary tract infection\n* affection of upper urinary tract\n* refractory hematuria\n* bladder stones\n* bladder diverticula\n\nExclusion Criteria:\n\n* patients with neurogenic bladder\n* patients with previous prostate or urethral surgery\n* associated urethral stricture\n* prostate cancer diagnosed by TRUS biopsy\n* prostate volume more than 80 ml'}, 'identificationModule': {'nctId': 'NCT04561505', 'briefTitle': 'HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.', 'orgStudyIdInfo': {'id': 'HoLEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Holmium laser enucleation of prostate', 'description': 'patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure', 'interventionNames': ['Procedure: Holmium laser enucleation of prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'monopolar transurethral resection of prostate', 'description': 'patients that undergo monopolar transurethral resection of prostate', 'interventionNames': ['Procedure: monopolar transurethral resection of prostate']}], 'interventions': [{'name': 'Holmium laser enucleation of prostate', 'type': 'PROCEDURE', 'description': 'surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation', 'armGroupLabels': ['Holmium laser enucleation of prostate']}, {'name': 'monopolar transurethral resection of prostate', 'type': 'PROCEDURE', 'description': 'surgical management of BPH by monopolar TURP using distilled water for irrigation', 'armGroupLabels': ['monopolar transurethral resection of prostate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11361', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ainshams university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Salah Sayed, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt'}, {'name': 'Amr Elshorbagy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor of urology, Ainshams university hospital, Cairo, Egypt'}, {'name': 'Mahmoud A. Mahmoud, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'assistant professor of urology, Ainshams university hospital, Cairo, Egypt'}, {'name': 'Diaaeldin Mostafa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'assistant professor of urology, Ainshams university hospital, Cairo, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Salah Sayed', 'investigatorAffiliation': 'Ain Shams University'}}}}