Holmium Laser Ablation of the Prostate (HoLAP) Versus KTP Laser Vaporization of the Prostate

NCT00169767 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2008-04-25

No results posted yet for this study

Summary

Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical standard to which all other operative treatments are compared. Although TURP provides excellent short and long-term results, this procedure has many potential risks and complications. The desire to avoid the potential risks of TURP and still achieve results of comparable durability has led to the development of alternative surgical procedures.

One such surgical alternative in the treatment of BPH is holmium laser ablation of the prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999). Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a normal saline irrigant. In addition, the hemostatic properties of the holmium laser results in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat using a tissue vaporization technique.

Recently, another laser technology has been introduced for the surgical treatment of BPH, the potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize obstructive prostate tissue, and has been studied through single arm clinical studies. Short-term results are promising, with significant improvements in voiding symptoms and urine flow rates as well as minimal associated morbidity. However, to date a randomized comparison study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group of investigators with extensive experience with both procedures intends to objectively compare these two procedures in a randomized clinical trial.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

OTHER

Comparison study between KTP and HoLAP for BPH

Comparison study between KTP and HoLAp for BPH

Sponsors & Collaborators

  • Lumenis Be Ltd.

    collaborator INDUSTRY
  • Indiana Kidney Stone Institute

    lead OTHER

Principal Investigators

  • James E Lingeman, MD · Methodist Urology, LLC

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00169767 on ClinicalTrials.gov