Clinical trial NCT03043222: Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Urinary Frequency/Urgency
Urinary Incontinence, Urge
Incontinence, Urinary
Nocturia
Keywords: prostate artery embolization
Prostatic Urethral Lift, Urolift
Minimally invasive
non-surgical
maintenance of sexual function
complications of TURP , surgery
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in QOL
timeFrame: 3,6,12 months
Secondary outcomes:
measure: Number of patients with clinical adverse events
timeFrame: 1 day, 8 days and 1,3,6,12 months
measure: Post operative morbidity
timeFrame: 1 day, 8 days and 1 month
measure: Recovery experience
timeFrame: 1 day, 8 days and 1 month
measure: Improvement in symptoms of LUTS
timeFrame: 3,6,12 months
measure: Lack of change in sexual function
timeFrame: 3,6,12 months
measure: Lack of change in ejaculation during sex
timeFrame: 3,6,12 months
measure: Lack of change in urinary incontinence
timeFrame: 3,6,12 months
measure: Change in Urinary flow after procedure
timeFrame: 3,6,12 months
measure: Change in Prostate volume after procedure
timeFrame: 3,6,12 months
measure: Change in residual urine left in bladder after procedure
timeFrame: 3,6,12 months
measure: Change in Prostatic specific antigen (PSA) after procedure
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Saint Louis University Hospital
name: Keith Pereira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Louis University Hospital
name: Beneranda Sophia Ford-Glanton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.