Urodynamic evaluation of patients with lower urinary tract symptoms and small prostate volume.
Cristiano M Gomes, Ricardo V Nunes, Rogerio M Araújo...
https://pubmed.ncbi.nlm.nih.gov/18758208Actively Recruiting
Phase Not Applicable
Age: 40Years - 80Years
MALE
ID07569874
Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia A Multicentre, Randomized, Single-Blind, Controlled Trial
Led by Chinese PLA General Hospital · Updated on 2026-05-06
426
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying men with small-volume benign prostatic hyperplasia (BPH), a condition that causes bladder outlet obstruction and bothersome urinary symptoms even when the prostate is not enlarged. This trial aims to evaluate the safety and effectiveness of thulium laser enucleation combined with bladder neck incision, comparing it to thulium laser enucleation alone and to the standard surgical method called transurethral resection of the prostate. The study will focus on how often bladder neck contracture occurs 6 months after surgery, along with symptom improvement and other health outcomes. The study is a multicenter, randomized, single-blind clinical trial enrolling 426 men aged 40 to 80 years. Participants will be randomly assigned to one of three groups: thulium laser enucleation combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. Treatments are performed transurethrally using laser or conventional surgical tools to remove obstructive prostate tissue. The combined procedure includes an additional bladder neck incision when deemed safe by the surgeon. Participants will be screened and then undergo surgery followed by follow-up visits at about 1 month, 3 months, and 6 months after surgery. During follow-up, researchers will assess urinary symptoms, urinary flow rates, pain levels, sexual function, and safety outcomes. A cystoscopy will be done at the 6-month visit to check for bladder neck contracture. The trial aims to provide evidence to improve surgical treatment options for men with small-volume BPH.
CONDITIONS
Brief Title
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Who Can Participate
Age: 40Years - 80Years
MALE
Eligibility Criteria
You may qualify if you...
- Male patients aged 40-80 years
- Diagnosed with benign prostatic hyperplasia and scheduled for surgical treatment
- International Prostate Symptom Score of at least 12 and maximum urinary flow rate of no more than 15 mL/s with voided volume over 150 mL
- Prostate volume less than 30 mL measured by transrectal ultrasound
- Ability to understand study requirements and complete treatment, follow-up, and assessments as assessed by the investigator
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with follow-up schedule
- Prostate-specific antigen level 10 ng/mL or higher unless prostate cancer is excluded by biopsy
- Confirmed or suspected prostate or bladder cancer
- Pre-existing bladder neck contracture or urethral stricture before surgery
- Known coagulation disorder or abnormal coagulation function
- Neurogenic bladder or detrusor underactivity affecting bladder or urethral sphincter function
- BPH complicated by acute urinary tract infection or prostatitis
- History of prostate surgery, urethral stricture, or neurogenic bladder
- History of prostate cancer or pelvic radiotherapy
- Severe cardiovascular, pulmonary, or systemic disease preventing surgery
- Participated in another BPH clinical trial within 3 months before enrollment
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo one of three surgical procedures: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, or transurethral resection of the prostate to treat small-volume benign prostatic hyperplasia.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 6 months
Participants are followed up to monitor recovery, assess symptoms, urinary function, and complications including bladder neck contracture.
3 visits at approximately 30, 90, and 180 days after surgery (in-person)
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
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Research Team
Q
Qing Yuan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms.
Stavros Gravas, Mauro Gacci, Christian Gratzke...
https://pubmed.ncbi.nlm.nih.gov/37202311Prostatic Artery Embolization: Indications, Preparation, Techniques, Imaging Evaluation, Reporting, and Complications.
Ubenicio Silveira Dias, Maurício Ruettimann Liberato de Moura, Publio Cesar Cavalcante Viana...
https://pubmed.ncbi.nlm.nih.gov/34415807The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis.
Shaun Wen Huey Lee, Esther Mei Ching Chan, Yin Key Lai
https://pubmed.ncbi.nlm.nih.gov/28801563Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management.
Lori B Lerner, Kevin T McVary, Michael J Barry...
https://pubmed.ncbi.nlm.nih.gov/34384237