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