Enucleation Ratio as a Novel Predictor of Symptomatic Improvement After HoLEP

NCT07591688 | Not Yet Recruiting

• 1 other identifier: MIUS.2026.003
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. The main question it aims to answer is: \- What is the minimum enucleation ratio required to achieve clinically important symptomatic improvement? (Symptomatic improvement is referred to as a threshold of having an International Prostate Symptom Score (IPSS) lower than 8 points, which is determined by the American Urological Association (AUA) and European Association of Urology(EAU)).

Conditions

Benign Prostate Obstruction (BPO)

Keywords

HoLEP; BPO; LUTS; Enucleation Ratio

Outcome Measures

Primary Outcomes (1)

• Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP

  The International Prostate Symptom Score (IPSS) is a validated questionnaire for lower urinary tract symptoms (LUTS). An IPSS score of 1-7 indicates mild LUTS, 8-19 moderate, and 20-35 severe LUTS, according to both the AUA and the EAU. Achievement of mild LUTS (IPSS \< 8) is widely accepted as a satisfactory surgical outcome. Therefore, the primary outcome was set as binary (IPSS \< 8 or otherwise). 3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.

  3 months after HoLEP

Secondary Outcomes (4)

• QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP

  3 months after HoLEP

• Qmax > 15 mL/s achievement rate at 3 months after HoLEP

  3 months after HoLEP

• Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP

  Within 1 month following HoLEP

• Ratio of stress urinary incontinence at 3 months after HoLEP

  3 months after HoLEP

Other Outcomes (2)

• PVR-R change 3 months after HoLEP

  3 months after HoLEP

• tPSA change 3 months after HoLEP

  3 months after HoLEP

Study Arms (1)

HoLEP

Males older than 18 years with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are planned to undergo holmium laser enucleation of the prostate (HoLEP) at participating centers.

Procedure: Holmium laser enucleation of prostate (HoLEP)

Interventions

Holmium laser enucleation of prostate (HoLEP) PROCEDURE

HoLEP is a widespread and minimally invasive surgical method to treat LUTS caused by BPO. En-bloc or tri-lobar technique will be performed according to the surgeon's preference during the procedure.

HoLEP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males with moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are scheduled to undergo holmium laser enucleation of the prostate (HoLEP) at participating urology centers across multiple institutions.

You may qualify if:

• Men aged 18 years pr older who are planned to undergo HoLEP.
• Participants who are willing to give informed consent.
• Participants who have moderate to severe LUTS (referring to IPSS score 8 points or more).
• No history of previous prostate or urethral surgery.

You may not qualify if:

• Unwillingness to provide informed consent.
• Unwillingness to provide contact information or unreachability during follow-up periods.
• Incidental diagnosis of a urogenital malignancy requiring primary treatment after enrollment (e.g., bladder tumor, renal cell carcinoma, testicular tumor).

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University, Faculty of Medicine, Department of Urology

Samsun, Turkey (Türkiye)

Location

Related Publications (3)

• Alkan I, Ozveri H, Akin Y, Ipekci T, Alican Y. Holmium laser enucleation of the prostate: surgical, functional, and quality-of-life outcomes upon extended follow-up. Int Braz J Urol. 2016 Mar-Apr;42(2):293-301. doi: 10.1590/S1677-5538.IBJU.2014.0561.

  PMID: 27256184 BACKGROUND

• Grosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, Cadenar A, Tellini R, Cocci A, Mari A, Minervini A, Tuccio A. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health. 2023 Jul;41(3):603-611. doi: 10.5534/wjmh.220042. Epub 2023 Jan 1.

  PMID: 36593708 BACKGROUND

• Jeong CW, Oh JK, Cho MC, Bae JB, Oh SJ. Enucleation ratio efficacy might be a better predictor to assess learning curve of holmium laser enucleation of the prostate. Int Braz J Urol. 2012 May-Jun;38(3):362-71; discussions 372. doi: 10.1590/s1677-55382012000300009.

  PMID: 22765867 BACKGROUND

Study Officials

• Murat Gulsen, Assistant Professor

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Gulsen, Assistant Professor

CONTACT

+905062357421; mglotr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)