Benign Prostatic HyperplasiaUNVEIL-BPONCT07699718
Selective Median Lobe Surgery Outcomes Study
An observational study of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), Benign Prostatic Obstruction
- What is being tested?
- Selective Median Lobe TURP and Selective Median Lobe HoLEP/AEEP
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Necmettin Erbakan University, Meram Faculty of Medicine
Konya, Konya, 42090
Selim Soyturk, MD, +90 332 223 60 44, selimsoyturk06@gmail.com
Selcuk Guven, MD, Professor
University of Health Sciences Türkiye, Van Training and Research Hospital
Van, Edremit, 65140
Ibrahim Goksoy, MD, +90 (432) 222 00 10, ibrahimgksy@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), Benign Prostatic Obstruction, Urinary Retention, Median Lobe Prostatic Enlargement
- Being tested
- Selective Median Lobe TURP, Selective Median Lobe HoLEP/AEEP
- Keywords
- Median lobe, Intravesical prostatic protrusion, Selective median lobe surgery, Selective median lobe enucleation, Selective median lobe resection, TURP, HoLEP, Anatomical endoscopic enucleation of the prostate, Uroflowmetry, Postvoid residual, Clinical failure, Ejaculation preservation
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Median Lobe TURPProcedure or surgery
Also called MLO-TURP, Median lobe-only 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.
Selective Median Lobe HoLEP/AEEPProcedure or surgery
Also called ML-HoLEP, Selective median lobe HoLEP, Selective median lobe anatomical endoscopic enucleation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Selective Median Lobe 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. Receives: Procedure: Selective Median Lobe HoLEP/AEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months after surgery
Proportion of Participants With Preserved Antegrade Ejaculation
Proportion of Participants With Preserved Antegrade Ejaculation
Measured: 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.
Measured: 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.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Soyturk, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699718
- Sponsor's protocol ID
- UNVEIL-BPO-ML-001
- Acronym
- UNVEIL-BPO
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 22866219Gul 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.
PubMed 31563537Press 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.
PubMed 36646177