Laser surgery showdown: does an extra incision improve outcomes for small prostates?
NCT ID NCT07688447
First seen Jul 07, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This trial compares two surgical approaches for men with small-volume benign prostatic hyperplasia (prostate size 30 mL or less). One group receives standard laser enucleation (ThuLEP), while the other gets ThuLEP plus a bladder neck incision. The goal is to see if the combined procedure improves urinary flow and reduces the risk of bladder neck contracture, a common complication in this patient group. The study involves 120 men aged 50–85 who need surgery for their symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) with or without bladder neck incision
- What this could lead to
- If successful, this could establish a better surgical approach for men with small prostates, potentially reducing complications like bladder neck contracture and improving urinary flow.
- What could go wrong
- This is a relatively small trial (120 participants) comparing two established procedures, so any advantage may be modest. The added incision could also increase risks like bleeding or scarring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male patients aged 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH), with a prostate volume ≤30 mL and requiring surgical intervention. * Preoperative International Prostate Symptom Score (IPSS) ≥8. * Preoperative maximum urinary flow rate (Qmax) ≤15 mL/s. * Bladder capacity ≥150 mL. * Willing to participate in this clinical trial and has signed the informed consent form. * Able to communicate well with investigators and comply with the study protocol requirements. Exclusion Criteria: * Patients with urethral stricture in whom passage of surgical instruments is not feasible. * Total PSA \>10 ng/mL, or PSA between 4-10 ng/mL with a free-to-total PSA ratio \<0.16, and confirmed malignancy on biopsy. * Coagulation disorders, including platelet count \<80 × 10⁹/L. * Uncontrolled urinary tract infection. * Neurogenic bladder. * Presence of malignant tumors. * Urodynamic diagnosis of bladder neck sclerosis, detrusor underactivity, detrusor-sphincter dyssynergia, or unstable bladder. * Contraindications to surgery, such as severe cardiopulmonary disease. * Cognitive impairment, including senile dementia, cerebral atrophy, acute cerebrovascular disease, sequelae of cerebrovascular disease, or other conditions affecting cognitive function. * History of suprapubic cystostomy for benign prostatic hyperplasia. * Acute localized or systemic bacterial infection that has not been effectively controlled. * Presence of shock or other critical conditions that preclude cooperation with the procedure and outcome evaluation. * Psychiatric or neurological disorders preventing cooperation with the study. * Participation in another clinical trial within 1 month prior to enrollment. * Any other condition deemed inappropriate for inclusion by the investigators.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai General Hospital
RECRUITINGShanghai, Shanghai Municipality, 200086, China
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