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Can a smarter needle angle make prostate relief safer and easier?

NCT ID NCT07776158

Disease control Sponsor: Qing Yuan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests a modified version of a minimally invasive procedure called prostatic urethral lift (PUL) for men with an enlarged prostate causing bothersome urinary symptoms. The new approach uses a zero-angle firing and needle-guided puncture technique to place implants more precisely at the prostate's apex, where space is tight. Twelve men aged 50–80 with moderate-to-severe symptoms will undergo the procedure and be followed for a year to see if it improves urinary flow, symptoms, and quality of life while preserving sexual function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified prostatic urethral lift procedure using zero-angle firing and needle-guided puncture
What this could lead to
If successful, this refined technique could make prostatic urethral lift easier and safer, offering men with BPH a less invasive way to relieve urinary symptoms without harming sexual function.
What could go wrong
This is a small, early exploratory study with only 12 participants, so results may not apply broadly. The procedure carries risks like bleeding, urinary urgency, infection, or the need for repeat treatment.

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

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

12 people

The number who actually took part.

Started

Jun 2023

Finished

Nov 2024

Lead sponsor

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

50 to 80 years

Sex

Male participants only

Healthy volunteers

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

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 to 80 years old; * Clinically diagnosed with benign prostatic hyperplasia accompanied by lower urinary tract symptoms; * Prostate volume measured by transabdominal or transrectal ultrasonography ranges from 30 mL to 80 mL; * International Prostate Symptom Score (IPSS) \> 12 points; * Maximum urinary flow rate (Qmax) ≤ 15 mL/s; * Voided volume ≥ 125 mL during uroflowmetry examination; * Post-void residual urine volume (PVR) measured by ultrasonography \< 350 mL; * Having sexual intercourse within 6 months prior to enrollment; * Sexual Health Inventory for Men (SHIM) score \> 6 points; * Preoperative clinical assessment confirms preservation of antegrade ejaculation; * Judged by the investigator to be eligible for prostatic urethral lift; * Able to understand the study content and voluntarily sign the written informed consent form; * Able to complete all scheduled follow-up visits in accordance with the study protocol. Exclusion Criteria: * Urethral conditions that preclude insertion of a 20F cystoscopic scope; * History of TURP, laser surgery, pelvic surgery, or radiotherapy; * Total prostate-specific antigen (tPSA) \> 10 ng/mL, or history of prostate cancer or bladder cancer; * Neurogenic bladder, urethral stricture, severe coagulopathy, or concurrent use of anticoagulants contraindicated for the procedure; * Intra-prostatic protrusion (IPP) \> 1 cm; * Other medical conditions or comorbidities contraindicating HoLEP or PUL; * Refusal to disclose sexual function status.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BPH (benign prostatic hyperplasia)

Contacts and locations

Locations

  • Chinese PLA Gerneral Hospital

    Beijing, Beijing Municipality, 100000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.