- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159406
Laser Prostatectomy Database and Registry
Laser Prostatectomy for Benign Prostatic Hyperplasia: A Registry and Database
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- IU Health Methodist Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cohort
Registry and Database
|
Data Collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to achieve continence
Time Frame: Ongoing
|
Ongoing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
No urinary retention
Time Frame: ongoing
|
ongoing
|
AUA SS
Time Frame: ongoing
|
ongoing
|
Bother index score
Time Frame: ongoing
|
ongoing
|
Decreased PSA
Time Frame: ongoing
|
ongoing
|
Decreased prostate size
Time Frame: ongoing
|
ongoing
|
Minimal complications
Time Frame: ongoing
|
ongoing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James E Lingeman, MD, IU Health Physicians Urology
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia
-
St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
San Carlo di Nancy HospitalElesta S.R.L.CompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy | Benign Prostatic Hypertrophy With Outflow Obstruction | Prostate HyperplasiaItaly
-
GlaxoSmithKlineCompletedBenign Prostatic Hyperplasia
-
Catholic University of the Sacred HeartCompletedBenign Prostatic Hyperplasia (BPH) | Benign Prostatic Enlargement (BPE)Italy
-
Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
-
Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
-
IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
-
IRCCS Policlinico S. MatteoCompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy With Outflow ObstructionItaly
-
American Medical SystemsCompletedBenign Prostatic Hyperplasia | BPH | Benign Prostatic Hypertrophy | Prostate Disease
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Not yet recruitingLower Urinary Tract Symptoms | Benign Prostate Hyperplasia | Benign Prostatic Hypertrophy With Outflow Obstruction
Clinical Trials on Registry and Database
-
Indiana Kidney Stone InstituteCompleted
-
King Faisal Specialist Hospital & Research CenterUnknownLeukemia, Myeloblastic, Acute
-
Indiana Kidney Stone InstituteCompleted
-
King Faisal Specialist Hospital & Research CenterUnknownLeukemia, Myeloid, Chronic
-
GlaxoSmithKlineTerminatedInfections, PapillomavirusNorway
-
King Faisal Specialist Hospital & Research CenterUnknownLymphoma, Non-Hodgkin | Hodgkin DiseaseSaudi Arabia
-
King Faisal Specialist Hospital & Research CenterUnknownLymphoma, Non-Hodgkin | Hodgkin DiseaseSaudi Arabia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingAcute Coronary Syndrome | Myocardium; InjuryItaly
-
King Faisal Specialist Hospital & Research CenterUnknown
-
Centre Hospitalier Universitaire, AmiensWithdrawn