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Lower Urinary Tract SymptomsNCT03043222

Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men

A study testing UroLift as artifical device for prostatic urethral lift. and Embospheres Microspheres as embolic agents for prostate artery embolization in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by St. Louis University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has… Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
UroLift as artifical device for prostatic urethral lift. and Embospheres Microspheres as embolic agents for prostate artery embolization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Mar 2018to 1 Jun 2019
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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male aged ≥40 yr Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study Diagnosis of urinary symptoms (LUTS) from prostatic enlargement (BPH) refractory to medical therapy for at least 6 months.
  • International Prostate Symptom Score >12

Who cannot join

  • PUL
  • Active urinary tract infections, prostatitis, or interstitial cystitis.
  • Biopsy proven prostate, bladder, or urethral cancer.
  • The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
  • Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
  • Patients with baseline PSA levels > 10 ng/mL
Show all 39Show fewer
  • Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
  • Significant median lobe enlargement.
  • Large prostates, volume >80 g.
  • Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.)
  • Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
  • Urethral conditions that may prevent insertion of a rigid 20F cystoscope
  • Current urinary retention.
  • Acontractile detrusor.
  • Current gross hematuria
  • Known upper tract renal disease
  • Cystolithiasis
  • ASA > 3 or severe medical debilitating condition
  • History of pelvic irradiation or radical pelvic surgery
  • Known allergy to nickel.
  • PAE
  • Active urinary tract infections, prostatitis, or interstitial cystitis.
  • Biopsy proven prostate, bladder, or urethral cancer.
  • The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
  • Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
  • Patients with baseline PSA levels > 10 ng/mL
  • Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
  • Unable to have CT angio of the prostate imaging
  • Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.)
  • Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
  • Acontractile detrusor.
  • Known upper tract renal disease
  • Cystolithiasis
  • Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. Known major iliac arterial occlusive disease
  • ASA > 3 or severe medical debilitating condition
  • Baseline serum creatinine level > 1.8 mg/dl
  • Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
  • History of pelvic irradiation or radical pelvic surgery
  • Allergy to iodinated contrast agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Saint Louis University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Effect of Prostatic Urethral Lift (PUL) Versus Prostate Arterial Embolization (PAE),Novel Minimally Invasive Treatment Options on Health-related Quality of Life (HRQoL) in Men With Lower Urinary Tract Symptoms Secondary to BPH.

For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter. Current medical and surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery times, degradation of sexual function and incontinence may negatively affect a patient's QoL.

Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar safety profiles. More importantly neither causes degradation of sexual function or urinary continence. Although multiple studies are being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from prostate enlargement.

Read the detailed description

As the population ages, there is a growing need to find ways for people to live longer with satisfactory quality of life (QoL), even in the midst of increasing health problems. For the ageing man, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome LUTS attributable to benign prostatic hypertrophy (BPH) and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter.

Current medical and surgical treatments like TURP for BPH offer symptomatic improvement of LUTS but may adversely affect a patient's QOL and satisfaction. Peri-operative complications and long recovery times, degradation of sexual function and iatrogenic incontinence may negatively affect a patient's QoL overall, resulting in patient viewing this as a treatment failure. Therefore when evaluating treatment options for BPH, treatment options with important QOL measures of satisfaction have to be considered.

Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Multiple prospective and retrospective studies have shown that both PUL and PAE yield relief of lower urinary tract symptoms over a period of several weeks. They display similar safety profiles with self-limiting pelvic discomfort characterizing the commonest minor adverse event. Both procedures are minimally invasive and have the potential to be carried out under local anesthesia and in the outpatient setting with suitability for patients with cardiovascular comorbidities. Another important finding is that neither has been found to cause degradation of sexual function.

Although there are an increasing number of data series being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. All the endpoints will be evaluated using validated questionnaires and laboratory values. Results of this study will be transferable to clinical practice and could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from LUTS due to BPH in all practice settings.

Being tested
UroLift as artifical device for prostatic urethral lift., Embospheres Microspheres as embolic agents for prostate artery embolization
Keywords
prostate artery embolization, Prostatic Urethral Lift, Urolift, Minimally invasive, non-surgical, maintenance of sexual function, complications of TURP , surgery
Medical subject headings
Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Urinary Incontinence, Urge, Urinary Incontinence, Nocturia

What participants receive

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

  • UroLift as artifical device for prostatic urethral lift.Device

    Also called Prostatic urethral lift.

    UroLift as artifical device for prostatic urethral lift. The PUL treatment is a minimally invasive approach to treating an enlarged prostate, or BPH, that lifts or holds the enlarged prostate tissue using clips so that it is out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.

  • Embospheres Microspheres as embolic agents for prostate artery embolizationDevice

    Also called Prostate artery embolization

    Embospheres Microspheres as embolic agents for prostate artery embolization Arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery to the prostate gland.Small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the enlarged prostate. The prostate is then expected to shrink , thus relieving urinary symptoms related to prostate enlargement.There is no cutting or removal of prostate tissue.Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.

Study groups in NCT03043222
Study groupRoleWhat they receive
PAE-Prostate Arterial EmbolizationExperimentalPAE-Prostate Arterial Embolization
Receives: Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization
PUL- Prostatic urethral liftActive comparatorPUL- Prostatic urethral lift
Receives: Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization

What is being measured

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

  1. Improvement in QOL

    Improvement in QOL score

    Measured: 3,6,12 months

Secondary outcomes (11)

  1. Number of patients with clinical adverse events

    Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications

    Measured: 1 day, 8 days and 1,3,6,12 months

  2. Post operative morbidity

    Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization

    Measured: 1 day, 8 days and 1 month

  3. Recovery experience

    Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)

    Measured: 1 day, 8 days and 1 month

  4. Improvement in symptoms of LUTS

    Reduction in International Prostate Symptom Score (IPSS) compared to baseline

    Measured: 3,6,12 months

  5. Lack of change in sexual function

    Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline

    Measured: 3,6,12 months

  6. Lack of change in ejaculation during sex

    Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)

    Measured: 3,6,12 months

  7. Lack of change in urinary incontinence

    Change in Incontinence severity index (ISI) score

    Measured: 3,6,12 months

  8. Change in Urinary flow after procedure

    Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.

    Measured: 3,6,12 months

  9. Change in Prostate volume after procedure

    Change in Prostate volume measured in cm3

    Measured: 3,6,12 months

  10. Change in residual urine left in bladder after procedure

    Change in Postvoid residual urine volume measured in ml

    Measured: 3,6,12 months

  11. Change in Prostatic specific antigen (PSA) after procedure

    Change in PSA level measured in pg/ml

    Measured: 3,6,12 months

Timeline

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

  1. First posted3 Feb 2017 (estimated)
  2. Study start1 Mar 2018 (estimated)
  3. Primary completion1 Apr 2019 (estimated)
  4. Study completion1 Jun 2019 (estimated)

Why it stopped: Withdrawn from IRB

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03043222
Sponsor's protocol ID
27936
Status last verified
Mar 2018
First submitted
2 Feb 2017
Last updated
20 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • McVary 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 21420124

  • Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015 Jun;22(3):7772-82.

    PubMed 26068624

  • Sonksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.

    PubMed 25937539

  • Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, Pereira J, Oliveira AG. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013 Sep;23(9):2561-72. doi: 10.1007/s00330-012-2714-9. Epub 2013 Jan 31.

    PubMed 23370938

  • Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, Rholl KS, Smirniotopoulos JB, van Breda A. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014 Jan;25(1):47-52. doi: 10.1016/j.jvir.2013.09.010. Epub 2013 Oct 28.

    PubMed 24176946

  • Uflacker AB, Haskal ZJ. Internal Iliac Artery Embolization for Benign Prostatic Hyperplasia? First Read the Fine Print. J Vasc Interv Radiol. 2015 Sep;26(9):1311-2. doi: 10.1016/j.jvir.2015.06.024. No abstract available.

    PubMed 26314640

  • Pisco JM, Bilhim T, Pinheiro LC, Fernandes L, Pereira J, Costa NV, Duarte M, Oliveira AG. Medium- and Long-Term Outcome of Prostate Artery Embolization for Patients with Benign Prostatic Hyperplasia: Results in 630 Patients. J Vasc Interv Radiol. 2016 Aug;27(8):1115-22. doi: 10.1016/j.jvir.2016.04.001. Epub 2016 Jun 16.

    PubMed 27321890

Questions about this trial

What is this clinical trial studying?

A study testing UroLift as artifical device for prostatic urethral lift. and Embospheres Microspheres as embolic agents for prostate artery embolization in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by St. Louis University at 1 site in United States.

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 2 inclusion and 39 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: withdrawn, as of the sponsor's last update on 20 Mar 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Improvement in QOL (time frame: 3,6,12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03043222, which also lists 7 linked publications.

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 Mar 2018.

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