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

This trial does not accept healthy volunteers

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 population

Men aged 45 years or older with moderate-to-severe lower urinary tract symptoms or urinary retention attributed to benign prostatic obstruction, in whom preoperative evaluation suggests median lobe-dominant or median lobe-related obstruction and who are scheduled to undergo selective median lobe transurethral surgery as part of routine clinical care at participating centers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Selective Median Lobe TURP

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Selective Median Lobe TURP1 intervention
Group B: Selective Median Lobe HoLEP/AEEP1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants With Composite Clinical Failure at 12 Months

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.

Time frame
12 months after surgery

Secondary outcomes

1

Change in International Prostate Symptom Score Total Score

Change in International Prostate Symptom Score total score from baseline to postoperative follow-up visits. Higher scores indicate more severe lower urinary tract symptoms.

Time frame
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
2

Change in International Prostate Symptom Score Voiding Subscore

Change in International Prostate Symptom Score voiding subscore from baseline to postoperative follow-up visits.Higher scores indicate more severe lower urinary tract symptoms

Time frame
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
3

Change in International Prostate Symptom Score Storage Subscore

Change in International Prostate Symptom Score storage subscore from baseline to postoperative follow-up visits.Higher scores indicate more severe lower urinary tract symptoms

Time frame
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
4

Change in International Prostate Symptom Score Quality of Life Score

Change in International Prostate Symptom Score quality of life score from baseline to postoperative follow-up visits. Higher scores indicate worse disease-specific quality of life.

Time frame
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery

Other outcomes

1

Performance of the Exploratory Urology-Based Median Lobe Failure Index

Exploratory evaluation of the Urology-Based Median Lobe Failure Index for predicting 12-month composite clinical failure. Model performance will be assessed using discrimination, calibration, and overall predictive performance measures. The index will not be used for clinical decision-making during the study.

Time frame
12 months after surgery

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