Selective Median Lobe Surgery Outcomes Study (UNVEIL-BPO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Urinary Retention; Benign Prostatic Obstruction; Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH); Median Lobe Prostatic Enlargement
• Intervention / Treatment: Procedure: Selective Median Lobe TURP; Procedure: Selective Median Lobe HoLEP/AEEP

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Ibrahim Goksoy, MD; Phone Number: +90 (432) 222 00 10; Email: ibrahimgksy@gmail.com
• Study Contact Backup: Name: Selim Soyturk, MD; Phone Number: +90 332 223 60 44; Email: selimsoyturk06@gmail.com

Study Locations

• Turkey (Türkiye)
  • Edremit
    • Van, Edremit, Turkey (Türkiye), 65140
      • University of Health Sciences Türkiye, Van Training and Research Hospital
      • Contact: Ibrahim Goksoy, MD; Phone Number: +90 (432) 222 00 10; Email: ibrahimgksy@gmail.com
  • Konya
    • Konya, Konya, Turkey (Türkiye), 42090
      • Necmettin Erbakan University, Meram Faculty of Medicine
      • Contact: Selim Soyturk, MD; Phone Number: +90 332 223 60 44; Email: selimsoyturk06@gmail.com
      • Principal Investigator: Selcuk Guven, MD, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.; Other Names: MLO-TURP; Median lobe-only TURP
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.	Procedure: 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.; Other Names: ML-HoLEP; Selective median lobe HoLEP; Selective median lobe anatomical endoscopic enucleation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
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	Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
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	Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
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.	Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in Maximum Urinary Flow Rate	Change in maximum urinary flow rate measured by uroflowmetry from baseline to postoperative follow-up visits.	Baseline, 3 months, 12 months, and 24 months after surgery
Change in Postvoid Residual Volume	Change in postvoid residual urine volume from baseline to postoperative follow-up visits.	Baseline, 3 months, 12 months, and 24 months after surgery
Proportion of Participants Restarting BPH-Related Medication	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.	Up to 24 months after surgery
Proportion of Participants Requiring BPH-Related Reintervention	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.	Up to 24 months after surgery
Proportion of Participants With Preserved Antegrade Ejaculation	Proportion of Participants With Preserved Antegrade Ejaculation	3 months, 12 months, and 24 months after surgery
Proportion of Participants With De Novo Ejaculatory Dysfunction	Proportion of participants reporting new ejaculatory dysfunction after surgery among those without ejaculatory dysfunction at baseline.	3 months, 12 months, and 24 months after surgery
Proportion of Participants With Postoperative Adverse Events or Late Anatomical Complications	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.	Up to 24 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after surgery

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Publications and helpful links

General Publications

• Gul Z, Chughtai B, Te AE, Thomas D, Kaplan SA. Ejaculatory Preserving Middle Lobe Onl-Transurethral Resection and Vaporization of the Prostate: 12-Year Experience. Urology. 2019 Dec;134:199-202. doi: 10.1016/j.urology.2019.07.042. Epub 2019 Sep 26.
• Lee JW, Ryu JH, Yoo TK, Byun SS, Jeong YJ, Jung TY. Relationship between Intravesical Prostatic Protrusion and Postoperative Outcomes in Patients with Benign Prostatic Hyperplasia. Korean J Urol. 2012 Jul;53(7):478-82. doi: 10.4111/kju.2012.53.7.478. Epub 2012 Jul 19.
• Press B, Gardezi M, Kim DD, Lokeshwar S, Rahman S, Siev M, Ghiraldi E, Lerner L, Kellner D. Ejaculatory Preserving Holmium Laser Enucleation of the Median Lobe: Preserving Sexual Function While Improving Urinary Outcomes. Urology. 2023 Mar;173:175-179. doi: 10.1016/j.urology.2022.12.035. Epub 2023 Jan 14.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: July 4, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HoLEP; TURP; Uroflowmetry; Postvoid residual; Intravesical prostatic protrusion; Ejaculation preservation; Median lobe; Selective median lobe surgery; Selective median lobe enucleation; Selective median lobe resection; Anatomical endoscopic enucleation of the prostate; Clinical failure
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Retention
• Other Study ID Numbers: UNVEIL-BPO-ML-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant data underlying the published results may be made available upon reasonable request after publication, subject to approval by the study steering committee and applicable ethics, institutional, and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No