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

Withdrawn before enrolling · Not applicable

Conditions studied: Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Frequency/Urgency, Urinary Incontinence, Urge, Incontinence, Urinary, Nocturia

In brief

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.

Key facts

Study ID

NCT03043222

Run by

St. Louis University

People needed

0

Starts

2018-03-01

Expected to finish

2019-06-01

Last updated by the study team

2018-03-20

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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