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Laser Prostatectomy Database and Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159406
Recruitment Status : Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Indiana Kidney Stone Institute

Brief Summary:


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 or disease Intervention/treatment
Benign Prostatic Hyperplasia Enlarged Prostate Other: Registry and Database

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.


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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Prostatectomy for Benign Prostatic Hyperplasia: A Registry and Database
Study Start Date : October 2003
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Registry and Database
Other: Registry and Database
Data Collection

Primary Outcome Measures :
  1. Time to achieve continence [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. No urinary retention [ Time Frame: ongoing ]
  2. AUA SS [ Time Frame: ongoing ]
  3. Bother index score [ Time Frame: ongoing ]
  4. Decreased PSA [ Time Frame: ongoing ]
  5. Decreased prostate size [ Time Frame: ongoing ]
  6. Minimal complications [ Time Frame: ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159406

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United States, Indiana
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
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Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
Publications of Results:
Other Publications:
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Responsible Party: Indiana Kidney Stone Institute Identifier: NCT00159406    
Other Study ID Numbers: 03-095
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Keywords provided by Indiana Kidney Stone Institute:
BPH treatment
Laser Prostatectomy
Treatment of enlarged Prostates
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases