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

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