Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07277556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TURP Outcome Prediction Calculator Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IPSS Score After TURP', 'timeFrame': '1 Month, 3 Months', 'description': 'Improvement in lower urinary tract symptoms measured by the International Prostate Symptom Score (IPSS - validated questionnaire ranging from 0 to 35 points, where higher scores indicate more severe symptoms) one month after TURP compared to baseline.'}, {'measure': 'Change in Qmax After TURP', 'timeFrame': '1 Month, 3 Months', 'description': 'Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP'}, {'measure': 'Change in Post-Void Residual Urine (PVR)', 'timeFrame': '1 Month, 3 Months', 'description': 'Reduction in ultrasound-measured residual urine after voiding following TURP'}, {'measure': 'Change in Voided Volume on Uroflowmetry', 'timeFrame': '1 Month, 3 Months', 'description': 'Improvement in total voided volume after TURP'}], 'secondaryOutcomes': [{'measure': 'Composite Surgical Success Rate', 'timeFrame': '1 Month, 3 Months', 'description': 'Proportion of patients achieving predefined surgical success, based on combined improvements in IPSS, Qmax, voided volume, and post-void residual urine'}, {'measure': 'Complication Rate Following TURP', 'timeFrame': '30 Days', 'description': 'Frequency of postoperative complications categorized using Clavien-Dindo classification of surgical complications ranging from Grade 1 to Grade V (Grade 1 representing minor deviations from the normal postoperative course and Grade V representing patient death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BPH', 'LUTS', 'TURP', 'Uroflowmetry', 'IPSS', 'Outcome Prediction'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to identify which preoperative clinical, ultrasound, and uroflowmetry parameters can help predict the success of transurethral resection of the prostate (TURP) in adult male patients with symptomatic benign prostatic hyperplasia (BPH). The main questions it aims to answer are:\n\nWhich preoperative parameters (IPSS, prostate volume, post-void residual urine, Qmax, comorbidities) are associated with successful postoperative outcomes?\n\nCan these parameters be used to develop a non-invasive calculator to estimate the likelihood of TURP success?\n\nParticipants will undergo routine clinical evaluation that is part of standard care, including:\n\n* completion of the IPSS questionnaire\n* digital rectal examination\n* ultrasound measurement of prostate volume and residual urine\n* uroflowmetry (Qmax and voided volume)\n* standard laboratory testing Eligible participants will then undergo TURP as clinically indicated and return for postoperative assessments of symptom improvement and urinary flow parameters.', 'detailedDescription': 'Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to lower urinary tract symptoms (LUTS), subvesical obstruction, and related complications such as urinary retention, bladder stones, recurrent infections, and renal impairment. Transurethral resection of the prostate (TURP) remains the standard surgical treatment for symptomatic benign prostatic obstruction (BPO). However, a subset of patients, particularly those with an underlying hypocontractile detrusor, may not benefit from TURP and continue to experience significant voiding dysfunction after surgery. Since formal urodynamic pressure-flow studies are invasive, time-consuming, and resource-intensive, there is clinical value in identifying non-invasive predictors of surgical success.\n\nThis prospective observational study will evaluate preoperative clinical, ultrasound, and uroflowmetry parameters associated with successful postoperative outcomes after TURP. Adult male patients with symptomatic BPH and an indication for TURP will undergo standardized assessment including medical history, IPSS questionnaire, digital rectal examination, serum PSA, ultrasound-determined prostate volume and post-void residual urine, and uroflowmetry parameters such as Qmax and voided volume. Comorbidities relevant to bladder function, including diabetes mellitus and neurological conditions, will be recorded. TURP will be performed according to standard clinical practice, and resected tissue will undergo routine histopathological evaluation.\n\nPostoperative follow-up will include IPSS reassessment, uroflowmetry, and ultrasound measurement of residual urine at one month and during subsequent routine evaluations. Surgical outcomes will be categorized as successful or unsuccessful based on subjective symptom improvement and objective urinary flow parameters. Using the collected data, the study will identify which preoperative variables correlate with favorable postoperative outcomes. These parameters will subsequently be used to inform the development of a predictive TURP outcome calculator.\n\nThe anticipated value of this study is to support individualized clinical decision-making in patients with BPH, particularly those in whom the distinction between obstruction and impaired detrusor contractility is unclear. By identifying patients who are less likely to benefit from TURP based on non-invasive parameters, the resulting calculator may help reduce unnecessary procedures, avoid postoperative morbidity, and potentially limit the need for invasive urodynamic testing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male patients with symptomatic benign prostatic hyperplasia undergoing clinically indicated transurethral resection of the prostate (TURP) at a single tertiary urology center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Clinical diagnosis of benign prostatic hyperplasia (BPH)\n* Indication for TURP based on symptoms or complications\n* Completed preoperative evaluation (IPSS, ultrasound, PSA, uroflowmetry)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Suspected or confirmed prostate cancer\n* No clinical evidence of BPH\n* Prior urodynamic diagnosis of underactive/neurogenic bladder\n* Prior prostate surgery\n* Inability to participate in follow-up'}, 'identificationModule': {'nctId': 'NCT07277556', 'acronym': 'TURP-SCORE', 'briefTitle': 'TURP Outcome Prediction Calculator Study', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital Sveti Duh'}, 'officialTitle': 'Identification of Predictive Parameters for Developing a TURP Outcome Calculator for Preoperative Patient Assessment', 'orgStudyIdInfo': {'id': 'KBSD-2025-03-3557'}, 'secondaryIdInfos': [{'id': 'KBSD-URO--2025', 'type': 'REGISTRY', 'domain': 'KB Sveti Duh Urology Institutional Research Registry'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adelina Hrkac, MD', 'role': 'CONTACT', 'email': 'adelina.surjan@gmail.com', 'phone': '00385958146992'}], 'overallOfficials': [{'name': 'Adelina Hrkac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinička bolnica "Sveti Duh", Zavod za urologiju'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital Sveti Duh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FEBU, Principal Investigator', 'investigatorFullName': 'Adelina Hrkac', 'investigatorAffiliation': 'General Hospital Sveti Duh'}}}}