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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
| Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
| Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
| Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
| Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
| Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
| Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
| Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
| Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
| Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
| Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
| Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
| Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
| Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
| Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
| Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
| Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
| Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
| Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
| Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |