Laser Prostatectomy Database and Registry



Status:Recruiting
Conditions:Prostate Cancer, Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:Hematology, Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:6/23/2018
Start Date:October 2003
End Date:December 2020
Contact:Kim Smoot
Email:ksmoot@iuhealth.org
Phone:317-962-0869

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Laser Prostatectomy for Benign Prostatic Hyperplasia: A Registry and Database

STATEMENT OF PURPOSE:

Transurethral resection of the prostate (TURP) is the standard surgical intervention for
obstructive benign prostatic hyperplasia (BPH) in all but the largest of glands, which are
typically treated with open simple prostatectomy. Recently, new generation lasers (holmium
and potassium titanyl phosphate [KTP]) have been utilized for BPH treatment. Long-term
follow-up of laser prostatectomy outcomes must be documented to fully characterize the degree
of voiding improvement achievable by these new techniques, the durability of these outcomes,
and the safety profiles of these procedures.

Benign prostatic hyperplasia (BPH) affects over 40% of men over the age of 60 (Kirby RS,
2000). For patients with significant obstructive symptoms which are not helped by medical
therapy, surgical intervention is instituted. Transurethral resection of the prostate (TURP),
an endoscopic procedure where prostate tissue is sequentially removed with an electrocautery
loop, remains the gold standard to which other surgical therapies are compared.
Unfortunately, TURP is associated with significant patient morbidity such as blood loss and
dilutional hyponatremia, especially when resection times are prolonged (Mebust WK et al,
1989).

Because of the long resection times and increased morbidity risks involved in patients with
extremely large prostate glands, open simple prostatectomy was traditionally employed in
place of TURP to remove the obstructing adenoma tissue. However, the patient could still
expect a prolonged hospital stay and a high likelihood of post-operative transfusion.

Many alternative surgical treatments for BPH have been developed in an attempt to minimize
the morbidity profile of the more traditional surgical approaches. New generation holmium
(2140 nm wavelength) and KTP (532 nm wavelength) lasers now offer a minimally invasive
alternative to BPH treatment broadly termed laser prostatectomy. Within the category of laser
prostatectomy, two distinctly separate techniques have been developed. The first, laser
ablation, involves the vaporization of obstructive prostate tissue. Effective ablation can be
achieved with either the holmium or KTP laser. Previous groups have reported favorable
outcomes with minimal associated morbidity when treating smaller prostates with the laser
ablation technique (Hai MA and Malek RS, 2003).

The properties of the holmium laser also enable it to cut soft tissue while maintaining
hemostasis, such that it can be utilized for dissecting entire prostatic lobes away from the
prostatic capsule. This procedure has been termed holmium laser enucleation of the prostate
(HoLEP), and it can be performed on even the largest of glands to duplicate the results of
open simple prostatectomy with much less morbidity (Gilling PJ et al, 2000 and Moody JA and
Lingeman JE, 2001).

We have performed both holmium and KTP prostate ablations and have had extensive clinical
experience with the HoLEP procedure. Our impressions of the various laser prostatectomy
procedure outcomes appear to substantiate the findings of the aforementioned studies.
However, extended follow-up of patients undergoing laser prostatectomies and documentation of
their outcomes and associated complications must be done in order to support the initial
conclusions of the previous investigators.

SPECIFIC AIMS:

To review the outcomes of our population of patients with BPH who have undergone laser
prostatectomy. We hypothesize that the long-term improvements in voiding parameters achieved
by these new laser procedures will compare favorably and perhaps be better than results
previously reported for TURP or, in the case of larger glands, open simple prostatectomy. In
addition, the adverse events/complication profile of the laser procedures should be better
than those of the traditional treatments. Once all retrospective data has been reviewed, we
will continue to collect outcome data on a prospective basis.

Inclusion Criteria:

- Patients of IU Health Physicians Urology in Indianapolis, Indiana

- Male patients over the age of 18 with benign prostatic hyperplasia requiring surgical
intervention for symptomatic relief.

Exclusion Criteria:

- Patients unable or unwilling to provide informed consent
We found this trial at
1
site
Indianapolis, Indiana 46202
Principal Investigator: James E Lingeman, MD
Phone: 317-962-0869
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from
Indianapolis, IN
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