Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Male patients aged 40-80 years.
Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.
International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL.
Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.52.
Disqualifiers
Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule.
Prostate-specific antigen (PSA) level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy.
Confirmed or suspected prostate or bladder malignancy.
Pre-existing bladder neck contracture or urethral stricture before surgery.
Trial design
Treatments tested in this trial
- Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision
- Thulium Laser Enucleation of the Prostate
- Transurethral Resection of the Prostate
Treatment groups
615 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov