Benign Prostatic Hyperplasia Clinical Trial
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.
Verified date | March 2018 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
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 R — View Citation
McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: — View 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 — View Citation
Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, Pereira J, Oliveira AG. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and m — View Citation
Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prost — View Citation
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in QOL | Improvement in QOL score | 3,6,12 months | |
Secondary | Number of patients with clinical adverse events | Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications | 1 day, 8 days and 1,3,6,12 months | |
Secondary | Post operative morbidity | Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization | 1 day, 8 days and 1 month | |
Secondary | Recovery experience | Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS) | 1 day, 8 days and 1 month | |
Secondary | Improvement in symptoms of LUTS | Reduction in International Prostate Symptom Score (IPSS) compared to baseline | 3,6,12 months | |
Secondary | Lack of change in sexual function | Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline | 3,6,12 months | |
Secondary | Lack of change in ejaculation during sex | Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD) | 3,6,12 months | |
Secondary | Lack of change in urinary incontinence | Change in Incontinence severity index (ISI) score | 3,6,12 months | |
Secondary | Change in Urinary flow after procedure | Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry. | 3,6,12 months | |
Secondary | Change in Prostate volume after procedure | Change in Prostate volume measured in cm3 | 3,6,12 months | |
Secondary | Change in residual urine left in bladder after procedure | Change in Postvoid residual urine volume measured in ml | 3,6,12 months | |
Secondary | Change in Prostatic specific antigen (PSA) after procedure | Change in PSA level measured in pg/ml | 3,6,12 months |
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