NCT07699718

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Sep 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 4, 2026

Last Update Submit

July 9, 2026

Conditions

Benign Prostatic HyperplasiaBenign Prostatic ObstructionUrinary RetentionMedian Lobe Prostatic EnlargementLower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

Keywords

Median lobeIntravesical prostatic protrusionSelective median lobe surgerySelective median lobe enucleationSelective median lobe resectionTURPHoLEPAnatomical endoscopic enucleation of the prostateUroflowmetryPostvoid residualClinical failureEjaculation preservation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in International Prostate Symptom Score Total Score

    Baseline, 3 months, 6 months, 12 months, and 24 months after surgery

  • Change in International Prostate Symptom Score Voiding Subscore

    Baseline, 3 months, 6 months, 12 months, and 24 months after surgery

  • Change in International Prostate Symptom Score Storage Subscore

    Baseline, 3 months, 6 months, 12 months, and 24 months after surgery

  • Change in International Prostate Symptom Score Quality of Life Score

    Baseline, 3 months, 6 months, 12 months, and 24 months after surgery

  • Change in Maximum Urinary Flow Rate

    Baseline, 3 months, 12 months, and 24 months after surgery

  • +6 more secondary outcomes

Other Outcomes (1)

  • Performance of the Exploratory Urology-Based Median Lobe Failure Index

    12 months after surgery

Study Arms (2)

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 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

Interventions

Selective Median Lobe TURPPROCEDURE

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.

Also known as: MLO-TURP, Median lobe-only TURP
Selective Median Lobe TURP
Selective Median Lobe HoLEP/AEEPPROCEDURE

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.

Also known as: ML-HoLEP, Selective median lobe HoLEP, Selective median lobe anatomical endoscopic enucleation
Selective Median Lobe HoLEP/AEEP

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Health Sciences Türkiye, Van Training and Research Hospital

Van, Edremit, 65140, Turkey (Türkiye)

Location

Necmettin Erbakan University, Meram Faculty of Medicine

Konya, Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 22866219BACKGROUND

  • 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: 31563537BACKGROUND

  • 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: 36646177BACKGROUND

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract SymptomsUrinary Retention

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Ibrahim Goksoy, MD

CONTACT

+90 (432) 222 00 10ibrahimgksy@gmail.com

Selim Soyturk, MD

CONTACT

+90 332 223 60 44selimsoyturk06@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologist / Coordinating Investigator

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

TU(2)