Laser Prostatectomy Database and Registry
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Benign Prostatic Hyperplasia Enlarged Prostate |
Other: Registry and Database |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Laser Prostatectomy for Benign Prostatic Hyperplasia: A Registry and Database |
- Time to achieve continence [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- No urinary retention [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- AUA SS [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Bother index score [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Decreased PSA [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Decreased prostate size [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Minimal complications [ Time Frame: ongoing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
cohort
Registry and Database
|
Other: Registry and Database
Data Collection
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients of IU Health Physicians Urology who are already scheduled to undergo a laser prostatectomy
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
Contacts and Locations| Contact: Lori Rawlings, RN | 317-962-0870 | lrawlings@iuhealth.org |
| United States, Indiana | |
| IU Health Methodist Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org | |
| Principal Investigator: James E Lingeman, MD | |
| Principal Investigator: | James E Lingeman, MD | IU Health Physicians Urology |
More Information
Additional Information:
Publications:
| Responsible Party: | Indiana Kidney Stone Institute |
| ClinicalTrials.gov Identifier: | NCT00159406 History of Changes |
| Other Study ID Numbers: | 03-095 |
| Study First Received: | September 8, 2005 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana Kidney Stone Institute:
|
BPH treatment Laser Prostatectomy Treatment of enlarged Prostates BPH |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013