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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Male patients aged 45 years or older.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim Goksoy, MD | Contact | +90 (432) 222 00 10 | ibrahimgksy@gmail.com | |
| Selim Soyturk, MD | Contact | +90 332 223 60 44 | selimsoyturk06@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Türkiye, Van Training and Research Hospital | Van | Edremit | 65140 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22866219 | Background | 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. | |
| 31563537 | Background | 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. |
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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.
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|
| 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. |
|
|
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 |
| Necmettin Erbakan University, Meram Faculty of Medicine | Konya | Konya | 42090 | Turkey (Türkiye) |
|
| 36646177 | Background | 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. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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