Selective Median Lobe Surgery Outcomes Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age45+
SponsorNecmettin Erbakan University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Selective Median Lobe TURP
  • Selective Median Lobe HoLEP/AEEP

Treatment groups

420 Participants
are divided into 2 treatment groups

Sponsors and collaborators