Predictors of Trifecta Achievement After HoLEP

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorOndokuz Mayıs University

About this trial

Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment option for men experiencing bothersome lower urinary tract symptoms due to an enlarged prostate. Researchers predict that specific participant or operator-dependent conditions before or during HoLEP may influence the trifecta outcome, based on similar studies. Therefore, the aim of this study is to understand what these conditions are. Trifecta success indicates a high-quality surgery based on three essential criteria: the treatment's effectiveness, ease of recovery, and the absence of serious side effects. In this study, trifecta is defined as relief from bothersome symptoms validated by international symptom score questionnaires, no urinary incontinence, and no serious events occurring within three months after HoLEP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All male patients aged ≥ 40 years who are candidates for surgical treatment for BPO.

Ability to provide informed consent, when required.

Disqualifiers

Clinically proven active condition(s) that require another intervention other than BPO surgery, such as lower urinary tract malignancy, urethral stricture, or neurogenic lower urinary tract symptoms.

History of previous surgery for BPO, urethral stricture, or prostate cancer.

Incomplete baseline or procedural data.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transurethral Holmium Laser Enuclation of the Prostate

    Procedure/Surgery

    HoLEP, En-bloc or tri-lobar technique.

Treatment groups

604 Participants
are divided into 1 treatment group
Group A: HoLEPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Trifecta achievement three months after HoLEP

Achievement of all three of the following criteria, three months after HoLEP: 1. At least a 30% reduction in International Prostate Symptom Score (IPSS) 2. Absence of major complications (no Clavien-Dindo grade \> II), 3. No urinary incontinence

Time frame
From enrollment to the three months after the intervention for each participant.

Secondary outcomes

1

Length of Hospital Stay After the Intervention

Duration of hospitalization following the intervention. Unit: days

Time frame
Perioperative/Periprocedural
2

Change in peak urinary flow rate (Qmax)

Difference in maximum urinary flow rate measured by uroflowmetry compared to baseline. Unit: mL/s

Time frame
Starting one month after the intervention and continuing for one year after the intervention, with multiple measurements.

Other outcomes

1

Bladder Voiding Efficiency (BVE)

Bladder voiding efficiency, defined as the ratio of voided volume to total bladder capacity. Ratio (unitless)

Time frame
From enrollment to the three months after the intervention.
2

Enucleation-Volume Ratio

Enucleation-volume ratio, defined as the ratio of enucleated adenoma weight to pre-operatively measured prostate volume. Ratio (unitless).

Time frame
Perioperative/Periprocedural

Sponsors and contacts

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