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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Urinary Incontinence, Urge; Nocturia; Incontinence, Urinary; Urinary Frequency/Urgency
• Intervention / Treatment: Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• PUL

  1. Active urinary tract infections, prostatitis, or interstitial cystitis.

  2. 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
  3. Significant median lobe enlargement.
  4. Large prostates, volume >80 g.
  5. 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.)
  6. 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
  7. Urethral conditions that may prevent insertion of a rigid 20F cystoscope
  8. Current urinary retention.
  9. Acontractile detrusor.
  10. Current gross hematuria
  11. Known upper tract renal disease
  12. Cystolithiasis
  13. ASA > 3 or severe medical debilitating condition
  14. History of pelvic irradiation or radical pelvic surgery

  15. Known allergy to nickel.

      PAE

  16. Active urinary tract infections, prostatitis, or interstitial cystitis.

  17. 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
  18. Unable to have CT angio of the prostate imaging
  19. 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.)
  20. 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
  21. Acontractile detrusor.
  22. Known upper tract renal disease
  23. Cystolithiasis
  24. 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
  25. ASA > 3 or severe medical debilitating condition
  26. Baseline serum creatinine level > 1.8 mg/dl
  27. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
  28. History of pelvic irradiation or radical pelvic surgery
  29. Allergy to iodinated contrast agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAE-Prostate Arterial Embolization	Device: UroLift as artifical device for 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.; Other Names: Prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for 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.; Other Names: Prostate artery embolization
Active Comparator: PUL- Prostatic urethral lift	Device: UroLift as artifical device for 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.; Other Names: Prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for 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.; Other Names: Prostate artery embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in QOL	Improvement in QOL score	3,6,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with clinical adverse events	Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications	1 day, 8 days and 1,3,6,12 months
Post operative morbidity	Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization	1 day, 8 days and 1 month
Recovery experience	Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)	1 day, 8 days and 1 month
Improvement in symptoms of LUTS	Reduction in International Prostate Symptom Score (IPSS) compared to baseline	3,6,12 months
Lack of change in sexual function	Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline	3,6,12 months
Lack of change in ejaculation during sex	Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)	3,6,12 months
Lack of change in urinary incontinence	Change in Incontinence severity index (ISI) score	3,6,12 months
Change in Urinary flow after procedure	Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.	3,6,12 months
Change in Prostate volume after procedure	Change in Prostate volume measured in cm3	3,6,12 months
Change in residual urine left in bladder after procedure	Change in Postvoid residual urine volume measured in ml	3,6,12 months
Change in Prostatic specific antigen (PSA) after procedure	Change in PSA level measured in pg/ml	3,6,12 months

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Keith Pereira, MD, Saint Louis University Hospital; Principal Investigator: Beneranda Sophia Ford-Glanton, MD, Saint Louis University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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. Erratum In: Eur Radiol. 2013 Sep;23(9):2573-4.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Minimally invasive; non-surgical; prostate artery embolization; Prostatic Urethral Lift, Urolift; maintenance of sexual function; complications of TURP , surgery
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Urologic Diseases; Urological Manifestations; Prostatic Diseases; Urination Disorders; Elimination Disorders; Urinary Incontinence; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Enuresis; Urinary Incontinence, Urge; Nocturia
• Other Study ID Numbers: 27936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes