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Not Yet Recruiting NCT07699718

Selective Median Lobe Surgery Outcomes Study

Conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), Benign Prostatic Obstruction, Urinary Retention, Median Lobe Prostatic Enlargement

Sex: Male
Ages: 45 Years – N/A
Healthy volunteers: No
Enrollment: 420
Sponsor: Necmettin Erbakan University

Location: University of Health Sciences Türkiye, Van Training and Research Hospital Van Edremit

Summary

This prospective multicenter observational cohort study will evaluate clinical outcomes after selective median lobe transurethral surgery for benign prostatic obstruction. Eligible men with lower urinary tract symptoms or urinary retention who are scheduled for selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care will be enrolled and followed after surgery. The study will collect preoperative clinical data, symptom scores, uroflowmetry, postvoid residual volume, prostate volume, intravesical prostatic protrusion measurements, cystoscopic anatomical findings, intraoperative variables, and postoperative outcomes. The primary outcome is composite clinical failure at 12 months. The main aim is to identify practical preoperative urology-based anatomical and functional predictors of clinical failure after selective median lobe surgery and to develop an exploratory prediction model that may help improve patient selection in future practice.

Eligibility Criteria

Inclusion Criteria: * Male patients aged 45 years or older. * Moderate-to-severe lower urinary tract symptoms due to benign prostatic obstruction or urinary retention requiring transurethral surgery. * Preoperative findings suggesting median lobe-dominant or median lobe-related obstruction. * Planned selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care. * Available baseline International Prostate Symptom Score, uroflowmetry and/or postvoid residual volume, prostate volume, intravesical prostatic protrusion measurement, and cystoscopic assessment. * Ability to provide written informed consent and comply with the follow-up schedule. Exclusion Criteria: * Previous prostate surgery for benign prostatic hyperplasia. * Known urethral stricture requiring treatment before or during the index procedure. * Known neurogenic lower urinary tract dysfunction. * Active prostate cancer or bladder cancer requiring treatment that may confound urinary outcomes. * Planned complete TURP, complete HoLEP/AEEP, or lateral lobe-dominant surgery. * Severe kissing lateral lobe obstruction considered to require complete surgery rather than selective median lobe surgery. * Inability to provide valid baseline or follow-up outcome data.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07699718). StuddyBuddy aggregates publicly available trial information.