Selective Median Lobe Surgery Outcomes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective Median Lobe TURP, Selective Median Lobe HoLEP/AEEP.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), Benign Prostatic Obstruction, Urinary Retention. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
UNVEIL-BPO Median Lobe Study: An International Multicenter Evaluation of Selective Median Lobe Resection and Enucleation
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Proportion of Participants With Composite Clinical Failure at 12 Months [Time frame: 12 months after surgery]
Secondary outcome measures (11)
- 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 Voiding Subscore [Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery]
- 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 Quality of Life Score [Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery]
- Change in Maximum Urinary Flow Rate [Time frame: Baseline, 3 months, 12 months, and 24 months after surgery]
- Change in Postvoid Residual Volume [Time frame: Baseline, 3 months, 12 months, and 24 months after surgery]
- Proportion of Participants Restarting BPH-Related Medication [Time frame: Up to 24 months after surgery]
- Proportion of Participants Requiring BPH-Related Reintervention [Time frame: Up to 24 months after surgery]
- Proportion of Participants With Preserved Antegrade Ejaculation [Time frame: 3 months, 12 months, and 24 months after surgery]
- Proportion of Participants With De Novo Ejaculatory Dysfunction [Time frame: 3 months, 12 months, and 24 months after surgery]
- Proportion of Participants With Postoperative Adverse Events or Late Anatomical Complications [Time frame: Up to 24 months after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 2 centers
- University of Health Sciences Türkiye, Van Training and Research Hospital — Van
- Necmettin Erbakan University, Meram Faculty of Medicine — Konya
Publications
- 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. PMID 22866219
- 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. PMID 31563537
- 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. PMID 36646177
Identifiers
NCT: NCT07699718 · UNVEIL-BPO-ML-001