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Enucleation Ratio as a Novel Predictor of Symptomatic Improvement After HoLEP

15. maj 2026 opdateret af: Murat Gulsen, Ondokuz Mayıs University

Predictive Value of Enucleation Ratio for Symptomatic Improvement After HoLEP: A Multicenter Prospective Cohort Study

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)).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

HoLEP has become a widespread and well-practiced surgical method for benign prostate obstruction (BPO). The method is known to have a steep learning curve, and mastery requires extensive practice. Treatment efficiency depends on removing the obstruction while protecting the delicate external urethral sphincter.

However, it's still unclear which pre-operative and intra-operative factors affect surgical outcome. Some authors have already contributed to this subject; in fact, changes in peak urinary flow rate, IPSS-QoL, and the absence of stress urinary incontinence and high-grade complications are among the agreed-upon criteria for successful surgery. As the main purpose of HoLEP, or any other benign prostate surgeries, is to remove obstruction, the more adenoma tissue to be removed, the less obstruction there will be. Yet not anatomic, but there's a surgical capsule around the prostate, which can stretch, causing residual tissue to obstruct the urethral passage. Leaving residual adenoma tissue is not uncommon and may affect the efficacy of HoLEP, particularly given the steep learning curve of the procedure. Therefore, it may be reasonable for one to consider that the higher the ratio of adenoma tissue removed, the better the outcomes could be.

Enucleation ratio is a novel parameter that has not been investigated previously in this context and is calculated by dividing the weight (grams) of morcellated adenoma tissue by the preoperatively measured prostate volume (mL). The density of the prostate is widely accepted as 1 gram per milliliter, so the enucleation ratio has no units.

Identifying a minimum enucleation ratio associated with clinically meaningful symptomatic improvement could provide surgeons with a measurable intraoperative target, potentially improving procedural standardization and patient counseling - particularly during the learning curve of HoLEP.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Murat Gulsen, Assistant Professor
  • Telefonnummer: +905062357421
  • E-mail: mglotr@gmail.com

Studiesteder

  • Tyrkiet (Türkiye)
      • Samsun, Tyrkiet (Türkiye)
        • Ondokuz Mayis University, Faculty of Medicine, Department of Urology
        • Kontakt:
          • Murat Gulsen, Assistant Professor
          • Telefonnummer: +905062357421
          • E-mail: mglotr@gmail.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP
Tidsramme: 3 months after HoLEP

The Quality of Life (QoL) score is a single validated question included in the IPSS questionnaire that assesses how much lower urinary tract symptoms affect a patient's daily life, scored from 0 (delighted) to 6 (terrible).

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

Maximum urinary flow rate (Qmax) is an objective measure of voiding efficiency assessed by uroflowmetry. A Qmax of 15 mL/s is widely accepted as the threshold distinguishing normal from impaired voiding, as referenced in EAU guidelines for non-neurogenic male LUTS.

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
Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP
Tidsramme: Within 1 month following HoLEP
In large HoLEP series, 30-day postoperative complications have been consistently reported using the Clavien-Dindo classification.
Within 1 month following HoLEP
Ratio of stress urinary incontinence at 3 months after HoLEP
Tidsramme: 3 months after HoLEP
Stress urinary incontinence, whether transient or permanent, is a well-recognized complication of HoLEP, and its absence at 3 months postoperatively is among the criteria for Trifecta achievement as defined in the literature.
3 months after HoLEP

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PVR-R change 3 months after HoLEP
Tidsramme: 3 months after HoLEP
Post-void residual ratio (PVR-R) is calculated by dividing post-void residual volume by total bladder capacity, both obtained from uroflowmetry. Although PVR-R is referenced in the EAU guidelines on urinary incontinence, it has not yet been established as a standard outcome measure in the BPH surgery literature. Nevertheless, expressing post-void residual as a ratio relative to total bladder capacity may offer a more individualized and reproducible measure compared to absolute volume alone, and its exploratory assessment following HoLEP may contribute to future standardization of voiding outcomes.
3 months after HoLEP
tPSA change 3 months after HoLEP
Tidsramme: 3 months after HoLEP
Total prostate-specific antigen (tPSA) is expected to decline following HoLEP due to the removal of adenoma tissue, and its postoperative change may serve as an indirect indicator of enucleation completeness. Furthermore, as preoperative tPSA correlates with prostate volume - from which the enucleation ratio is derived - it is considered a potential confounder in the primary analysis and will be assessed exploratorily to better understand its relationship with both the predictor and the primary outcome.
3 months after HoLEP

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ondokuz Mayıs University

Efterforskere

  • Ledende efterforsker: Murat Gulsen, Assistant Professor, Ondokuz Mayıs University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

30. marts 2027

Datoer for studieregistrering

Først indsendt

9. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • MIUS.2026.003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK).

Only aggregated, de-identified results will be reported in publications and presentations.

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