Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04391114 |
| Other study ID # |
2019518 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2019 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Thunder Bay Regional Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland,
places pressure on the urethra and causes urination difficulties and bladder problems. Lower
Urinary Tract Symptoms (LUTS) secondary to BPH is a common condition in aging men, with an
overall prevalence of more than 50% in those older than 50 years of age. Men with LUTS often
experience sexual dysfunction including ejaculatory loss, painful ejaculation, and erectile
dysfunction, which among other complications can also lead to a decreased quality of life.
Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in
1998, is a more recent step in the evolution of holmium laser prostatectomy. HOLEP offers
patients the alternative of being treated endoscopically with minimal blood loss, short
catheterization time, and decreased hospital stay.
One noted drawback to HoLEP, and the primary reason why it has yet to become the new standard
for treatment of symptomatic BPH, is the complexity of this procedure, with a prolonged
learning curve. Modifications to the procedure have thus been explored in order to address
this limitation. The "Top-Down" HoLEP technique is a novel technique which offers potential
benefits to the Traditional HoLEP procedure, including decreased complexity, a reduced
learning curve, with anticipated improved continence.
This study will compare the operating time between the Top-Down Holmium Laser Enucleation of
the prostate (HoLEP) and the Traditional HoLEP for the treatment of patients with symptomatic
bladder outlet obstruction due to BPH in Northwestern Ontario.
Description:
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland,
places pressure on the urethra and causes urination difficulties and bladder problems. Lower
Urinary Tract Symptoms (LUTS) secondary to BPH is a common condition in aging men, with an
overall prevalence of more than 50% in those older than 50 years of age. Men with LUTS often
experience sexual dysfunction including ejaculatory loss, painful ejaculation, and erectile
dysfunction, which among other complications can also lead to a decreased quality of life.
Conventional Transurethral Resection of the Prostate (TURP), a surgical technique in which
excess prostate tissue is removed using a resectoscope, remains the gold standard treatment
in most centres for symptomatic BPH. However, morbidity after TURP is high, especially
bleeding requiring blood transfusion (0.4-6.4%) and late postoperative bleeding (1.3-1.7%).
Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in
1998, is a more recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe
and effective procedure which has demonstrated comparable results to TURP and open
prostatectomy for patients with symptomatic enlarged prostate, with low morbidity and short
hospital stay. The improvement in outcome parameters is durable, and the late complications
and reoperation rates reported are very low. HoLEP is equally suitable for small, medium and
larger prostate glands, with clinical outcomes that are independent of prostate size, unlike
TURP. HOLEP offers patients the alternative of being treated endoscopically with minimal
blood loss, short catheterization time, and decreased hospital stay.
One noted drawback to HoLEP, and the primary reason why it has yet to become the new standard
for treatment of symptomatic BPH, is the complexity of this procedure, with a prolonged
learning curve as compared to TURP. Modifications to the procedure have thus been explored in
order to address this limitation. The "Top-Down" HoLEP technique is a novel technique which
offers potential benefits to the Traditional HoLEP procedure, including decreased complexity,
a reduced learning curve, with anticipated improved continence. A variation of this method is
also being explored in Japan (termed the "en-bloc technique with anteroposterior dissection
HoLEP"). The main difference between the Top-Down and Traditional approach is that the
direction of lateral dissection begins from upwards to downwards. This could help in avoiding
the overtraction of the mucosal strip overlying the posterior urethral sphincter, which
theoretically leads to a decrease in the incidence of postoperative stress incontinence.
Moreover, using the Top-Down approach should lead to a decrease in the incidence of lost
enucleation planes, which results in decreasing the intraoperative time and decreasing the
number of cases required to master the HoLEP technique.
In a recent retrospective review of this technique in Indiana, promising early operative
results in a small sample size were demonstrated. The mean enucleation time and mean
enucleation rate were both faster when comparing the 49 patients who underwent the top-down
technique as compared to those 37 patients who underwent the traditional HoLEP technique.
While the results of this particular study are limited by the relatively small number of
cases and retrospective nature of the study, the potential value of this technique is
evident. A retrospective review of 26 patients who underwent surgery using the en-bloc
technique in Japan led to similar conclusions regarding the complexity of the procedure and
improvement of rates. While this procedure demonstrates potential over the conventional TURP
treatment and traditional HoLEP treatment of symptomatic BPH, the specific techniques of the
Top-down technique must be further explored.
Our most recent online publication about Top-Down HoLEP early outcomes in 60 patients who
underwent HoLEP between 2017 and 2018 with median prostate volume of 124ml (70-266)
demonstrated at 3 months follow-up, the urine stream significantly improved with a median
Qmax 23.6 mL/s (17-42). Two patients (3.3%) had urge incontinence, and 2 other patients
(3.3%) had stress incontinence at 3 months follow-up.
This study will compare the operating time between the Top-Down Holmium Laser Enucleation of
the prostate (HoLEP) and the Traditional HoLEP for the treatment of patients with symptomatic
bladder outlet obstruction due to BPH in Northwestern Ontario.
