Selective Median Lobe Surgery Outcomes Study

NCT07699718 · tracked via the Priya Life Science Turkey tracker

Sponsor

Necmettin Erbakan University

Phase

Observational

Started

2026-09-01

Last updated

2026-07-13

Condition(s) studied

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)Benign Prostatic ObstructionUrinary RetentionMedian Lobe Prostatic Enlargement

Investigational drug(s) / intervention(s)

Selective Median Lobe TURPSelective Median Lobe HoLEP/AEEP

Selective Median Lobe TURP: 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: 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 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

Sex

MALE

Min age

45 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of Participants With Composite Clinical Failure at 12 Months — 12 months after surgery
Composite clinical failure is defined as the presence of at least one of the following within 12 months or at the 12-month assessment: inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication due to recurrent or persistent voiding symptoms, recurrent urinary retention or need for recatheterization after the early postoperative period, need for reintervention, or patient-reported global failure due to insufficient urinary benefit.

Trial sites (2)

Facility	City	Region	Status
University of Health Sciences Türkiye, Van Training and Research Hospital	Van	Edremit
Necmettin Erbakan University, Meram Faculty of Medicine	Konya	Konya

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07699718 on ClinicalTrials.gov ↗ ← All trials in Turkey