Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlarg… (NCT03043222) | Clinical Trial Compass
WithdrawnNot Applicable
Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
Stopped: Withdrawn from IRB
United States0Started 2018-03-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Active urinary tract infections, prostatitis, or interstitial cystitis.
. Biopsy proven prostate, bladder, or urethral cancer.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has been withdrawn and is no longer recruiting, can you tell me if the research on minimally invasive treatments for BPH and lower urinary tract symptoms it was exploring is available through any other active studies or published findings I should know about?
2Because this trial was labeled 'Phase NA' and has since been withdrawn, what does that tell us about how much safety and effectiveness data exists for the minimally invasive approaches it was studying compared to standard BPH treatments?
3Given that this trial focused on quality of life improvements for symptoms like urinary urgency, nocturia, and urge incontinence, what currently available minimally invasive options exist that have already completed research and might address those same symptoms for me?
4Since the trial is no longer running, are there similar active trials looking at minimally invasive BPH treatments that my specific symptoms — like nighttime urination or urge incontinence — might make me a good candidate to discuss with you?
5Compared to the minimally invasive approaches this withdrawn trial was studying, would a more established treatment like medication or a standard surgical procedure be a safer or better-evidenced path to improving my quality of life right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.