Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia

Sponsor
Chinese PLA General Hospital
Study ID
NCT07569874
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision — PROCEDURE
    Participants will undergo transurethral thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
  • Thulium Laser Enucleation of the Prostate — PROCEDURE
    Participants will undergo transurethral thulium laser enucleation of the prostate alone. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound. No bladder neck incision will be performed as part of the assigned intervention.
  • Transurethral Resection of the Prostate — PROCEDURE
    Participants will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.

Study Details

This study will evaluate the safety and effectiveness of thulium laser enucleation of the prostate combined with bladder neck incision in men with small-volume benign prostatic hyperplasia (BPH). Small-volume BPH may still cause significant bladder outlet obstruction and bothersome lower urinary tract symptoms, and the optimal surgical treatment for these patients remains uncertain. In this multicenter, randomized, single-blind, controlled trial, 426 eligible men aged 40 to 80 years will be assigned in a 1:1:1 ratio to one of three groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. The main goal is to compare the incidence of bladder neck contracture at 6 months after surgery. Other outcomes include symptom improvement, urinary flow, pain score, sexual function, and safety outcomes during follow-up.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
426 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ThuLEP Combined With Bladder Neck Incision
    Participants assigned to this arm will undergo thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
  • Active Comparator: ThuLEP Alone
    Participants assigned to this arm will undergo thulium laser enucleation of the prostate alone. The procedure will be performed transurethrally, and hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound.
  • Active Comparator: Transurethral Resection of the Prostate
    Participants assigned to this arm will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.

Primary Outcome Measure

Incidence of Bladder Neck Contracture [ Time Frame: 6 months after surgery (180 ± 7 days) ]

Central Contacts

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