NCT00159406

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

22.2 years

First QC Date

September 8, 2005

Last Update Submit

January 22, 2025

Conditions

Benign Prostatic HyperplasiaEnlarged Prostate

Keywords

BPH treatmentLaser ProstatectomyTreatment of enlarged ProstatesBPH

Outcome Measures

Primary Outcomes (1)

  • Time to achieve continence

    Ongoing

Secondary Outcomes (6)

  • No urinary retention

    ongoing

  • AUA SS

    ongoing

  • Bother index score

    ongoing

  • Decreased PSA

    ongoing

  • Decreased prostate size

    ongoing

  • +1 more secondary outcomes

Study Arms (1)

cohort

Registry and Database

Other: Registry and Database

Interventions

Registry and DatabaseOTHER

Data Collection

cohort

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

  • 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.

    PMID: 15989443BACKGROUND

  • 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.

    PMID: 12818001RESULT

  • 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.

    PMID: 12796668RESULT

  • 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.

    PMID: 16094022RESULT

  • 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.

    PMID: 15989444RESULT

  • 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.

    PMID: 12837423RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Registries

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James E Lingeman, MD

    IU Health Physicians Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2003

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations

US(1)