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BPH (Benign Prostatic Hyperplasia)mPUL-ZANCT07776158

Efficacy and Safety of Modified Prostatic Urethral Lift (mPUL-ZA) for Benign Prostatic Hyperplasia

A study testing Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia in people with BPH (Benign Prostatic Hyperplasia), run by Qing Yuan at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Abstract Background: Transurethral prostatic suspension and expansion, internationally referred to as prostatic urethral lift (PUL), is a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). Read more about this study

Who is it for?
Ages 50 to 80 years, men only
Conditions the study is for
BPH (Benign Prostatic Hyperplasia)
What is being tested?
Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Jun 2023to 27 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Chinese PLA Gerneral Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: Efficacy and Safety of Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia: A Prospective, Single-Center, Single-Arm Exploratory Study

Abstract

Background:

Read more

Transurethral prostatic suspension and expansion, internationally referred to as prostatic urethral lift (PUL), is a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). However, implant deployment at the prostatic apex may be technically difficult because of limited lateral operating space and obstruction by the pubic arch. A modified technique involving zero-angle firing and needle-guided puncture was developed to facilitate implant placement in this region.

Objective:

This study aims to evaluate the feasibility, preliminary efficacy, and safety of the modified transurethral prostatic suspension and expansion procedure using zero-angle firing and needle-guided puncture in men with BPH-related lower urinary tract symptoms.

Methods:

This is a prospective, single-center, single-arm, open-label exploratory interventional study involving 12 male participants. The principal eligibility criteria include an age of 50-80 years, a prostate volume of 30-80 mL, an International Prostate Symptom Score (IPSS) greater than 12, a maximum urinary flow rate (Qmax) of 15 mL/s or less with a voided volume of at least 125 mL, and a post-void residual urine volume (PVR) of less than 350 mL. Patients with previous prostate surgery, confirmed or suspected prostate cancer, neurogenic bladder, urethral stricture, severe coagulation disorders, or anticoagulant therapy that cannot be safely discontinued or adjusted will be excluded.

All participants will undergo the modified transurethral prostatic suspension and expansion procedure. Implants will be deployed in the proximal and middle portions of the prostate using the conventional technique. At the prostatic apex, particularly when lateral rotation is restricted or pubic arch interference is anticipated, the delivery device will be maintained at the urethral midline in a neutral, zero-angle orientation. The needle will be fired in this position, followed by incremental manual compression to facilitate adequate tissue capture and needle-guided penetration of the prostatic capsule. The implant will then be tensioned and deployed.

Participants will be evaluated at baseline and followed at 14 days, 30 days, 90 days, and 12 months after surgery. The primary outcome is the change in IPSS from baseline to 90 days after surgery. Secondary outcomes include changes in quality-of-life score, Qmax, PVR, and Sexual Health Inventory for Men score; technical success; operative time; number of implants; estimated blood loss; catheterization duration; and length of hospital stay. Safety outcomes include gross hematuria, urinary urgency, dysuria, urinary retention, re-catheterization, urinary tract infection, urethral stricture, readmission, device-related adverse events, secondary intervention, and reoperation.

Continuous outcomes will be summarized using appropriate descriptive statistics and compared between baseline and follow-up using a paired-samples t-test or Wilcoxon signed-rank test, depending on the distribution of paired differences. Categorical variables will be reported as frequencies and percentages. All statistical tests will be two-sided, with a significance level of 0.05. Given the exploratory nature and small sample size, effect estimates and confidence intervals will be emphasized alongside P values.

Expected significance:

This study is expected to provide preliminary evidence regarding whether zero-angle firing and needle-guided puncture can facilitate implant deployment at the prostatic apex while improving urinary symptoms, urinary flow, and quality of life without adversely affecting erectile function. The findings may support the design of subsequent multicenter, controlled studies with larger sample sizes.

Keywords:

benign prostatic hyperplasia; lower urinary tract symptoms; transurethral prostatic suspension and expansion; prostatic urethral lift; zero-angle firing; needle-guided puncture; minimally invasive treatment

Registration information:

Study period: June 1, 2023 to December 31, 2023; ethics approval date: August 31, 2023; ethics approval number: S2023-493-01; principal investigator: Qing Yuan; planned sample size: 20 participants; registration status: retrospectively registered.

Read the detailed description

Abstract

Background:

Transurethral prostatic suspension and expansion, internationally referred to as prostatic urethral lift (PUL), is a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). However, implant deployment at the prostatic apex may be technically difficult because of limited lateral operating space and obstruction by the pubic arch. A modified technique involving zero-angle firing and needle-guided puncture was developed to facilitate implant placement in this region.

Objective:

This study aims to evaluate the feasibility, preliminary efficacy, and safety of the modified transurethral prostatic suspension and expansion procedure using zero-angle firing and needle-guided puncture in men with BPH-related lower urinary tract symptoms.

Methods:

This is a prospective, single-center, single-arm, open-label exploratory interventional study involving 12 male participants. The principal eligibility criteria include an age of 50-80 years, a prostate volume of 30-80 mL, an International Prostate Symptom Score (IPSS) greater than 12, a maximum urinary flow rate (Qmax) of 15 mL/s or less with a voided volume of at least 125 mL, and a post-void residual urine volume (PVR) of less than 350 mL. Patients with previous prostate surgery, confirmed or suspected prostate cancer, neurogenic bladder, urethral stricture, severe coagulation disorders, or anticoagulant therapy that cannot be safely discontinued or adjusted will be excluded.

All participants will undergo the modified transurethral prostatic suspension and expansion procedure. Implants will be deployed in the proximal and middle portions of the prostate using the conventional technique. At the prostatic apex, particularly when lateral rotation is restricted or pubic arch interference is anticipated, the delivery device will be maintained at the urethral midline in a neutral, zero-angle orientation. The needle will be fired in this position, followed by incremental manual compression to facilitate adequate tissue capture and needle-guided penetration of the prostatic capsule. The implant will then be tensioned and deployed.

Participants will be evaluated at baseline and followed at 14 days, 30 days, 90 days, and 12 months after surgery. The primary outcome is the change in IPSS from baseline to 90 days after surgery. Secondary outcomes include changes in quality-of-life score, Qmax, PVR, and Sexual Health Inventory for Men score; technical success; operative time; number of implants; estimated blood loss; catheterization duration; and length of hospital stay. Safety outcomes include gross hematuria, urinary urgency, dysuria, urinary retention, re-catheterization, urinary tract infection, urethral stricture, readmission, device-related adverse events, secondary intervention, and reoperation.

Continuous outcomes will be summarized using appropriate descriptive statistics and compared between baseline and follow-up using a paired-samples t-test or Wilcoxon signed-rank test, depending on the distribution of paired differences. Categorical variables will be reported as frequencies and percentages. All statistical tests will be two-sided, with a significance level of 0.05. Given the exploratory nature and small sample size, effect estimates and confidence intervals will be emphasized alongside P values.

Expected significance:

This study is expected to provide preliminary evidence regarding whether zero-angle firing and needle-guided puncture can facilitate implant deployment at the prostatic apex while improving urinary symptoms, urinary flow, and quality of life without adversely affecting erectile function. The findings may support the design of subsequent multicenter, controlled studies with larger sample sizes.

Keywords:

benign prostatic hyperplasia; lower urinary tract symptoms; transurethral prostatic suspension and expansion; prostatic urethral lift; zero-angle firing; needle-guided puncture; minimally invasive treatment

Registration information:

Study period: June 1, 2023 to December 31, 2023; ethics approval date: August 31, 2023; ethics approval number: S2023-493-01; principal investigator: Qing Yuan; planned sample size: 20 participants; registration status: retrospectively registered.

Being tested
Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia
Keywords
benign prostatic hyperplasia, lower urinary tract symptoms, prostatic urethral lift, zero-angle firing, needle-guided puncture, minimally invasive treatment
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic HyperplasiaProcedure or surgery

    Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia

Study groups in NCT07776158
Study groupRoleWhat they receive
Single Surgical InterventionExperimentalAll enrolled patients receive unified surgical intervention, with standardized follow-up to observe clinical efficacy and safety indicators.
Receives: Procedure: Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Prostate Symptom Score (IPSS) change from baseline

    The IPSS score ranges from 0 to 35 points; higher scores indicate more severe lower urinary tract symptoms.

    Measured: Intraoperative period

  2. Quality of life (QoL) score change from baseline

    QoL score ranges from 0 to 6 points; higher scores indicate poorer quality of life

    Measured: intraoperative period

  3. Maximum urinary flow rate (Qmax) change from baseline

    Unit: ml/s; the higher the value, the better the urination function

    Measured: Intra-operative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2023
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07776158
Sponsor's protocol ID
S2023-493-01
Acronym
mPUL-ZA
Status last verified
Jun 2026
First submitted
8 Aug 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia in people with BPH (Benign Prostatic Hyperplasia), run by Qing Yuan at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Prostate Symptom Score (IPSS) change from baseline (time frame: Intraoperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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