[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656834":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":33,"studyPopulation":24,"armGroups":34,"interventions":47,"overallOfficials":24,"centralContacts":57,"locations":63,"responsibleParty":83,"collaborators":24,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":24,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":24,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":24,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Beni-Suef University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Stone-Free Rate (SFR)","Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray \\[KUB\\]) for all patients.","4 to 6 weeks postoperatively",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in International Prostate Symptom Score (IPSS)\" Unit of Measure: Units on a Scale ( Score on a Scale)","Evaluation of urinary symptoms and voiding parameters including International Prostate Symptom Score (IPSS, range 0-35),","Baseline, 1 month, 3 months, and 6 months postoperatively",{"measure":19,"description":20,"timeFrame":17},"\"Change in Maximum Urinary Flow Rate (Qmax)\" Unit of Measure: mL\u002Fs (milliliters per second)","Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL\u002Fs",{"measure":22,"description":23,"timeFrame":17},"Change in Post-Void Residual Urine Volume (PVR)","Post-void residual urine volume (PVR) assessed by ultrasonography.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":31},"SINGLE",[32],"OUTCOMES_ASSESSOR","Urinary bladder calculi represent approximately 5% of all urinary calculi, with secondary stones constituting the vast majority (\\>95%) of cases in adult men, predominantly secondary to bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH).\n\nWhile current guidelines debate the necessity of routine concomitant outlet obstruction relief at initial stone surgery, evidence remains needed regarding single-stage versus selective staged treatment.\n\nThis prospective, randomized, single-center study will be conducted at the Urology Department, Beni-Suef University. A total of 104 eligible male patients aged 40 years or older with symptomatic BPH (IPSS \\>= 8, prostate size \\>= 30g, Qmax \\\u003C= 15 ml\u002Fs) and imaging-confirmed bladder calculus\u002Fcalculi will be randomly allocated (1:1 allocation using computer-generated block randomization) into one of two parallel groups:\n\n* Group 1: Managed with transurethral cystolitholapaxy alone.\n* Group 2: Managed with transurethral cystolitholapaxy with concomitant TURP.\n\nAll participants undergo comprehensive preoperative evaluation including medical history, International Prostate Symptom Score (IPSS), total and free PSA, urine analysis and culture, abdominopelvic ultrasound (assessing stone dimensions, prostate volume, post-void residual urine \\[PVR\\]), and uroflowmetry (Qmax).\n\nFollow-up evaluations are conducted at 1 month, 3 months, and 6 months postoperatively to assess the stone-free rate (SFR), stone recurrence rate, functional outcomes (IPSS, Qmax, PVR), and postoperative adverse events graded by the Clavien-Dindo classification system. Patients in Group 1 will be specifically monitored to identify independent risk factors necessitating delayed TURP during the follow-up period.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Cystolitholapaxy Alone","ACTIVE_COMPARATOR","Patients undergo transurethral cystolitholapaxy alone to clear bladder calculi, followed by conservative medical management of BPH and follow-up to evaluate the need for subsequent delayed TURP.",[40],"Procedure: Transurethral Cystolitholapaxy Alone",{"label":42,"type":43,"description":44,"interventionNames":45},"Cystolitholapaxy + Concomitant TURP","EXPERIMENTAL","Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting.",[46],"Procedure: Transurethral Resection of the Prostate (TURP)",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":24},"PROCEDURE","Transurethral Cystolitholapaxy Alone","Transurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery.",[36],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":24},"Transurethral Resection of the Prostate (TURP)","Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy.",[42],[58],{"name":59,"role":60,"phone":61,"phoneExt":24,"email":62},"Mahmoud Abdallah Mahmoud, lecturer of urology","CONTACT","01155361979","mahmoud.abdalla@med.bsu.edu.eg",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Faculty of Medicine, Beni-Suef University","RECRUITING","Banī Suwayf","Beni Suweif Governorate","62511","Egypt","EG",{"type":73,"coordinates":74},"Point",[75,76],31.09785,29.07441,{"lat":76,"lon":75},[79],{"name":80,"role":60,"phone":81,"phoneExt":24,"email":82},"doaa mahmoud khalil, assistant professor","01152091011","drm_abdallah_88@yahoo.com",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mahmoud Abdallah","lecturer of urology","100656834","impact-of-concomitant-turp-on-bladder-stone-surgery-outcomes-100656834",false,"NCT07831486","Impact of Concomitant TURP on Bladder Stone Surgery Outcomes","Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study","Inclusion Criteria:\n\n* Adult men aged 40 years or older.\n* Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).\n* International Prostate Symptom Score (IPSS) \\>= 8.\n* Prostate size \\>= 30 grams (measured by ultrasonography).\n* Maximum urinary flow rate (Qmax) \\\u003C= 15 mL\u002Fs.\n* Presence of urinary bladder calculus\u002Fcalculi confirmed by diagnostic imaging.\n* Written informed consent provided prior to study enrollment.\n\nExclusion Criteria:\n\n* Evidence or history of urethral stricture.\n* Known or suspected prostate cancer.\n* Known or suspected bladder cancer \u002F urothelial malignancy.\n* Neurogenic bladder dysfunction.\n* Chronic urinary retention with overflow incontinence.\n* Previous prostate or bladder neck surgery (e.g., prior TURP, TUIP, open prostatectomy).\n* Active urinary tract infection (UTI) at the time of surgery (patients treated for infection preoperatively may be reassessed for eligibility).","MALE","40 Years",{"count":97,"type":98},104,"ESTIMATED","INTERVENTIONAL",[101],"NA","The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively.\n\nThe primary objective of this prospective randomized comparative study is to compare the postoperative outcomes of cystolitholapaxy alone versus cystolitholapaxy with concomitant TURP in adult male patients presenting with bladder calculi secondary to BPH. Additionally, the study aims to identify clinical and urodynamic predictors for requiring subsequent (delayed) TURP among patients initially treated with stone surgery alone.",[104],"Bladder Stone","2026-09-16",{"date":107,"type":108},"2026-09-21","ACTUAL",{"date":110,"type":98},"2026-10",{"date":112,"type":98},"2028-07",{"name":5,"class":6},1]