Laser Prostatectomy Database and Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana Kidney Stone Institute
Sponsor:
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00159406
First received: September 8, 2005
Last updated: June 23, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • Time to achieve continence [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Patients of IU Health Physicians Urology who are already scheduled to undergo a laser prostatectomy

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159406

Contacts
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org

Locations
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         
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
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: June 23, 2014
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 July 24, 2014