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NCT Number: NCT07699718

Selective Median Lobe Surgery Outcomes Study

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.

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Key information

About this study

Selective median lobe transurethral surgery is used in selected men with benign prostatic obstruction in whom the median lobe or high bladder neck median component is considered the dominant obstructive anatomy. This approach may provide urinary improvement while potentially reducing ejaculatory dysfunction compared with complete transurethral prostate surgery. However, some patients may experience persistent or recurrent symptoms because of residual lateral lobe obstruction, unfavorable bladder neck anatomy, insufficient functional improvement, or bladder dysfunction.

This study is designed as a prospective multicenter observational cohort. The surgical decision and the choice of technique will not be assigned by the study protocol. Patients will undergo selective median lobe TURP, selective median lobe HoLEP, or selective median lobe anatomical endoscopic enucleation according to the treating surgeon's routine clinical judgment.

The study will evaluate whether preoperative urology-based variables can predict 12-month clinical failure. Candidate predictors include intravesical prostatic protrusion length or grade, cystoscopic median lobe morphology, lateral lobe obstruction score, bladder neck configuration, baseline symptom burden, storage symptom burden, uroflowmetry pattern, Qmax, and postvoid residual volume. Intraoperative variables, including procedure type, energy platform, extent of lateral lobe treatment, bladder neck management, operative time, tissue weight, catheter duration, and complications will also be recorded.

The primary endpoint is 12-month composite clinical failure, defined by inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication, 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.

Secondary outcomes include changes in IPSS, quality of life, uroflowmetry parameters, postvoid residual volume, durability of response, medication-free survival, reintervention-free survival, preservation of antegrade ejaculation, de novo ejaculatory dysfunction, urinary incontinence, urethral stricture, bladder neck contracture, and Clavien-Dindo complications.

The study will also explore the performance of a practical urology-based Median Lobe Failure Index. This index will be evaluated as an exploratory tool only and will not be used to guide clinical decision-making during the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MLO-TURP, Median lobe-only TURP

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.

Other names: ML-HoLEP, Selective median lobe HoLEP, Selective median lobe anatomical endoscopic enucleation

Primary outcomes

  1. Proportion of Participants With Composite Clinical Failure at 12 Months

    Time frame: 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.

Secondary outcomes

  1. Change in International Prostate Symptom Score Total Score

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

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

  2. Change in International Prostate Symptom Score Voiding Subscore

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

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

  3. Change in International Prostate Symptom Score Storage Subscore

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

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

  4. Change in International Prostate Symptom Score Quality of Life Score

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

    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.

  5. Change in Maximum Urinary Flow Rate

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

    Change in maximum urinary flow rate measured by uroflowmetry from baseline to postoperative follow-up visits.

  6. Change in Postvoid Residual Volume

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

    Change in postvoid residual urine volume from baseline to postoperative follow-up visits.

  7. Proportion of Participants Restarting BPH-Related Medication

    Time frame: Up to 24 months after surgery

    Proportion of participants who restart medication for benign prostatic hyperplasia or lower urinary tract symptoms after the early postoperative period because of persistent or recurrent symptoms.

  8. Proportion of Participants Requiring BPH-Related Reintervention

    Time frame: Up to 24 months after surgery

    Proportion of participants requiring additional intervention for benign prostatic obstruction, including bladder neck incision, repeat TURP, repeat HoLEP or AEEP, lateral lobe surgery, or another BPH-related surgical procedure.

  9. Proportion of Participants With Preserved Antegrade Ejaculation

    Time frame: 3 months, 12 months, and 24 months after surgery

    Proportion of Participants With Preserved Antegrade Ejaculation

  10. Proportion of Participants With De Novo Ejaculatory Dysfunction

    Time frame: 3 months, 12 months, and 24 months after surgery

    Proportion of participants reporting new ejaculatory dysfunction after surgery among those without ejaculatory dysfunction at baseline.

  11. Proportion of Participants With Postoperative Adverse Events or Late Anatomical Complications

    Time frame: Up to 24 months after surgery

    Proportion of participants with postoperative adverse events or late anatomical complications, including urinary incontinence, urethral stricture, bladder neck contracture, urinary tract infection, urinary retention, bleeding, or other complications classified according to the Clavien-Dindo system when applicable.

Other outcomes

  1. Performance of the Exploratory Urology-Based Median Lobe Failure Index

    Time frame: 12 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Goksoy, MD

CONTACT

[email protected]

+90 (432) 222 00 10

Selim Soyturk, MD

CONTACT

[email protected]

+90 332 223 60 44

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

UNVEIL-BPO Median Lobe Study: An International Multicenter Evaluation of Selective Median Lobe Resection and Enucleation

Acronym: UNVEIL-BPO

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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