Benign Prostatic HyperplasiaNCT07873125
Ultrasound-Guided vs. Conventional Prostate Suspension in BPH: An Exploratory Study
A study testing Ultrasound-Guided Prostatic Urethral Lift and Conventional Prostatic Urethral Lift in people with Benign Prostatic Hyperplasia, run by Shanghai East Hospital at 1 site in China.
Trial summary
This is an exploratory, prospective, single-center, open-label, 1:1 randomized controlled study. The study compares two surgical methods for benign prostatic hyperplasia (BPH): ultrasound-guided prostate suspension and conventional prostate suspension. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Ultrasound-Guided Prostatic Urethral Lift and Conventional Prostatic Urethral Lift
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
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 aged 50-80 years. Clinical diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS).
- International Prostate Symptom Score (IPSS) ≥12. Maximum urinary flow rate (Qmax) ≤15 mL/s (measured at a voided volume ≥125 mL).
- Prostate volume 30-100 mL (measured by transrectal ultrasound or MRI). Post-void residual urine (PVR) ≤250 mL. Unsatisfactory response to medication or refusal of long-term medication. Signed informed consent. American Society of Anesthesiologists (ASA) physical status classification I-III.
Who cannot join
- Prior prostate surgery (e.g., transurethral resection of the prostate [TURP], laser enucleation).
- Confirmed or highly suspected prostate cancer (PSA >10 ng/mL or positive biopsy).
- Neurogenic bladder dysfunction. Urethral stricture or bladder neck contracture. Bladder stones or recurrent urinary tract infection. Active urinary tract infection. Coagulation disorders. Acute urinary retention. Participation in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of Ultrasound-Guided Prostate Suspension Versus Conventional Prostate Suspension in the Treatment of Benign Prostatic Hyperplasia
This is an exploratory, prospective, single-center, open-label, 1:1 randomized controlled study. The study compares two surgical methods for benign prostatic hyperplasia (BPH): ultrasound-guided prostate suspension and conventional prostate suspension. BPH is a common condition in older men that can cause lower urinary tract symptoms (LUTS), such as frequent urination, weak urine stream, and difficulty emptying the bladder. The purpose of this study is to learn whether using ultrasound guidance during prostate suspension can improve urinary symptoms and urine flow more than the standard procedure, while preserving sexual function and maintaining safety.
About 20 men aged 50-80 years with BPH and bothersome LUTS will be enrolled. Eligible participants must have an IPSS score of 12 or higher, a maximum urine flow rate (Qmax) of 15 mL/s or less, a prostate volume of 30-100 mL, and a post-void residual urine (PVR) of 250 mL or less. They must be dissatisfied with medication or refuse long-term medication and be able to give informed consent. Men with prior prostate surgery, suspected or confirmed prostate cancer, neurogenic bladder, urethral stricture, bladder neck contracture, bladder stones, recurrent urinary tract infection, active urinary infection, bleeding disorders, acute urinary retention, or current participation in another interventional trial cannot take part.
Read more
Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group will receive ultrasound-guided prostate suspension. In this procedure, the standard UroLift prostate suspension is performed with ultrasound guidance, and at least one additional suspension implant is placed on each side. The control group will receive the standard NeoTract UroLift System procedure. Both procedures are minimally invasive and are performed through the urethra without cutting prostate tissue. The study is open-label, meaning participants and surgeons know which procedure is used, but the staff who assess outcomes will be blinded to group assignment to reduce bias.
The main outcome is the change in IPSS at 12 months after surgery. Secondary outcomes include changes in Qmax, quality of life (IPSS-QoL), PVR, sexual function (IIEF-5), complications, and retreatment rate. Follow-up visits will occur at about 1, 3, 6, and 12 months after surgery. The total study duration is about 36 months.
All surgery has risks. Possible risks include bleeding, infection, pain, urinary symptoms, urinary retention, implant-related problems, or the need for further treatment. The study team will monitor participants closely and provide standard medical care as needed. This study may help doctors understand whether ultrasound-guided prostate suspension offers better symptom relief than the standard procedure. Participation is voluntary, and participants may withdraw at any time without affecting their usual medical care.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Ultrasound-Guided Prostatic Urethral Lift, Conventional Prostatic Urethral Lift
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Prostatic Urethral LiftProcedure or surgery
A minimally invasive transurethral procedure using the NeoTract UroLift System. Under real-time ultrasound guidance in addition to standard cystoscopic visualization, permanent nitinol implants are placed to pull the enlarged prostate lateral lobes outward and secure them toward the prostate capsule, thereby expanding the compressed urethra and relieving bladder outlet obstruction. Compared with the conventional procedure, at least one additional set of suspension implants is placed on each side. No prostate tissue is resected. This intervention is distinguished from conventional PUL by the use of ultrasound guidance and the placement of additional implants.
Conventional Prostatic Urethral LiftProcedure or surgery
Standard minimally invasive transurethral prostatic urethral lift using the NeoTract UroLift System under direct cystoscopic visualization without ultrasound guidance. Permanent nitinol implants are typically placed 1-2 per side (2-4 implants total) to lift and fix the obstructing prostate lateral lobes, expanding the urethra and relieving bladder outlet obstruction. No prostate tissue is resected. This is the conventional comparator procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Prostate Suspension | Experimental | Participants undergo ultrasound-guided prostate suspension using the NeoTract UroLift System. Under ultrasound guidance, the UroLift delivery device is inserted transurethrally, and permanent nitinol implants are placed to pull the enlarged prostate lateral lobes outward and fix them toward the prostate capsule, thereby expanding the compressed urethra and relieving bladder outlet obstruction. Compared with the standard procedure, at least one additional set of suspension implants is placed on each side. No prostate tissue is resected. The procedure is minimally invasive and may be performed under local, spinal, or general anesthesia according to clinical practice. Postoperative care follows standard institutional protocols. Receives: Procedure: Ultrasound-Guided Prostatic Urethral Lift |
| Conventional Prostate Suspension | Active comparator | Participants undergo standard conventional prostate suspension using the NeoTract UroLift System without ultrasound guidance. Under direct cystoscopic visualization, the delivery device is inserted transurethrally, and permanent nitinol implants are typically placed 1-2 per side (2-4 implants total) to lift and fix the obstructing prostate lateral lobes, thereby expanding the urethra. No prostate tissue is resected. The procedure is generally performed under general anesthesia. A urinary catheter is usually left in place and removed after 1 day. Postoperative care follows standard institutional protocols. Receives: Procedure: Conventional Prostatic Urethral Lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS) from Baseline to 12 Months After Surgery
Change in total IPSS score at 12 months after surgery compared with baseline (postoperative IPSS minus baseline IPSS). The IPSS is a 7-item questionnaire; total score ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The expected between-group difference is >3 points.
Measured: Baseline (preoperative) and 12 months after surgery
Secondary outcomes (5)
Change in Maximum Urinary Flow Rate (Qmax) at 3, 6, and 12 Months After Surgery Compared with Baseline
Change in Qmax (postoperative value minus baseline value). Qmax is measured by uroflowmetry; a voided volume of at least 125 mL is required for a valid measurement. Expected between-group difference: >3 mL/s.
Measured: Baseline and 3, 6, and 12 months after surgery
Change in International Prostate Symptom Score Quality of Life Item (IPSS-QoL) at 3, 6, and 12 Months After Surgery Compared with Baseline
Change in IPSS-QoL (Item 8 of the IPSS) from baseline. The IPSS-QoL is completed by the participant; higher scores indicate worse quality of life related to urinary symptoms.
Measured: Baseline and 3, 6, and 12 months after surgery
Change in Post-Void Residual Urine (PVR) at 1, 3, 6, and 12 Months After Surgery Compared with Baseline
Change in PVR (postoperative value minus baseline value). PVR is measured by ultrasound and reflects bladder emptying function. Lower PVR indicates better bladder emptying.
Measured: Baseline and 1, 3, 6, and 12 months after surgery
Change in International Index of Erectile Function-5 (IIEF-5) Score at 1 and 12 Months After Surgery Compared with Baseline
Change in IIEF-5 score (postoperative value minus baseline value). The IIEF-5 is used to assess sexual function, including erectile function. Higher scores indicate better sexual function.
Measured: Baseline and 1 and 12 months after surgery
Incidence of Complications Graded by Clavien-Dindo Classification
Incidence, severity, and type of postoperative complications, graded according to the Clavien-Dindo classification. Between-group comparison of complication rates will be performed.
Measured: Through 12 months after surgery (cumulative at postoperative day 30, 90, 180, and 360)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873125
- Sponsor's protocol ID
- 2026YS-302
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study results will be disseminated through publication in peer-reviewed journals and conference presentations.
Publications
Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
PubMed 21420124Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6.
PubMed 7563343Roehrborn CG, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, McVary KT. Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. J Urol. 2017 Jun;197(6):1507-1516. doi: 10.1016/j.juro.2016.12.045. Epub 2016 Dec 18.
PubMed 27993667McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
PubMed 30677455Elterman D, Gao B, Lu S, Bhojani N, Zorn KC, Chughtai B. New Technologies for Treatment of Benign Prostatic Hyperplasia. Urol Clin North Am. 2022 Feb;49(1):11-22. doi: 10.1016/j.ucl.2021.07.007. Epub 2021 Oct 25.
PubMed 34776045Franco A, Ditonno F, Manfredi C, Bologna E, Licari LC, Orecchia L, Finazzi Agro E, Antonelli A, Arlandis S, Autorino R, Tarcan T, Cornu JN, Elterman D, Kaplan S, Lombardo R, McVary K, Secco S, Cindolo L, De Nunzio C. Systematic Review and Pooled Analysis of Functional and Sexual Outcomes of Minimally Invasive Surgical Treatments for Benign Prostatic Obstruction. Eur Urol. 2026 Apr;89(4):318-331. doi: 10.1016/j.eururo.2025.09.004. Epub 2025 Sep 17.
PubMed 40967932