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Active, not recruitingNCT00159406Updated Jan 23, 2025

Laser Prostatectomy Database and Registry

An observational study in Benign Prostatic Hyperplasia and Enlarged Prostate, sponsored by Indiana Kidney Stone Institute. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.

Sponsored by Indiana Kidney Stone Institute · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Enlarged Prostate

Keywords

  • BPH treatment
  • Laser Prostatectomy
  • Treatment of enlarged Prostates
  • BPH
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Indiana Kidney Stone Institute is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients unable or unwilling to provide informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)

Groups and cohorts

  • cohort

    Registry and Database

    Other: Registry and Database

Interventions

  • OtherRegistry and Database

    Data Collection

06

What researchers measure

Primary outcomes

  1. Time to achieve continence

    Time frame: Ongoing

Secondary outcomes

  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

07

Study locations

1 site
  • IU Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
08

References and documents

Publications

  • Tinmouth WW, Habib E, Kim SC, Kuo RL, Paterson RF, Terry CL, Elhilali M, Lingeman JE. Change in serum prostate specific antigen concentration after holmium laser enucleation of the prostate: a marker for completeness of adenoma resection? J Endourol. 2005 Jun;19(5):550-4. doi: 10.1089/end.2005.19.550. PubMed 15989443 ↗
  • Kuo RL, Paterson RF, Kim SC, Siqueira TM Jr, Elhilali MM, Lingeman JE. Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update. World J Surg Oncol. 2003 Jun 6;1(1):6. doi: 10.1186/1477-7819-1-6. PubMed 12818001 ↗
  • Kuo RL, Kim SC, Lingeman JE, Paterson RF, Watkins SL, Simmons GR, Steele RE. Holmium laser enucleation of prostate (HoLEP): the Methodist Hospital experience with greater than 75 gram enucleations. J Urol. 2003 Jul;170(1):149-52. doi: 10.1097/01.ju.0000070686.56806.a1. PubMed 12796668 ↗
  • Peterson MD, Matlaga BR, Kim SC, Kuo RL, Soergel TM, Watkins SL, Lingeman JE. Holmium laser enucleation of the prostate for men with urinary retention. J Urol. 2005 Sep;174(3):998-1001; discussion 1001. doi: 10.1097/01.ju.0000170230.26743.e4. PubMed 16094022 ↗
  • Kim SC, Matlaga BR, Kuo RL, Watkins SL, Kennett KM, Gilling PJ, Lingeman JE. Holmium laser enucleation of the prostate: a comparison of efficiency measures at two institutions. J Endourol. 2005 Jun;19(5):555-8. doi: 10.1089/end.2005.19.555. PubMed 15989444 ↗
  • Kuo RL, Paterson RF, Siqueira TM Jr, Watkins SL, Simmons GR, Steele RE, Lingeman JE. Holmium laser enucleation of the prostate: morbidity in a series of 206 patients. Urology. 2003 Jul;62(1):59-63. doi: 10.1016/s0090-4295(03)00124-9. PubMed 12837423 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00159406
Lead sponsor
Indiana Kidney Stone Institute
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Oct 2003
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 23, 2025

Study contacts

James E Lingeman, MD
principal investigator · IU Health Physicians Urology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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