Selective Median Lobe Surgery Outcomes Study

Sponsor
Necmettin Erbakan University
Study ID
NCT07699718
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selective Median Lobe TURP — PROCEDURE
    Selective transurethral resection of the median lobe or median component of the bladder outlet. The procedure is performed according to the treating surgeon's routine clinical practice and is not assigned by the study protocol.
  • Selective Median Lobe HoLEP/AEEP — PROCEDURE
    Selective enucleation of the median lobe or median component of the bladder outlet using HoLEP or another anatomical endoscopic enucleation platform. The procedure is performed according to the treating surgeon's routine clinical practice and is not assigned by the study protocol.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2030

Study Design

Enrollment
420 participants (estimated)

Arms

  • Arm: Selective Median Lobe TURP
    Men undergoing selective transurethral resection of the median lobe for benign prostatic obstruction as part of routine clinical care, without planned complete lateral lobe resection.
  • Arm: Selective Median Lobe HoLEP/AEEP
    Men undergoing selective median lobe holmium laser enucleation or another anatomical endoscopic enucleation technique for benign prostatic obstruction as part of routine clinical care, without planned complete gland enucleation.

Primary Outcome Measure

Proportion of Participants With Composite Clinical Failure at 12 Months [ Time Frame: 12 months after surgery ]

Central Contacts

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