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

NCT00169767 | Terminated

• 1 other identifier: 05-042
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Enlarged Prostate; BPH

Outcome Measures

Primary Outcomes (1)

• operative parameters, short and long-term results, and complications associated with HoLAP and KTP laser vaporization of the prostate

  2 years

Study Arms (1)

A

Comparison study between KTP and HoLAP procedures for BPH

Other: Comparison study between KTP and HoLAP for BPH

Interventions

Comparison study between KTP and HoLAP for BPH OTHER

Comparison study between KTP and HoLAp for BPH

Also known as: BPH

A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

urology clinic

You may qualify if:

• Ability to give informed consent
• Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia
• Maximum urinary flow rate \< 15 ml/sec, voided volume ≥ 125 cc
• American Urological Association symptom score ≥ 9
• Transrectal ultrasound determined prostate volume ≤ 60 cc

You may not qualify if:

• Inability to give informed consent
• Maximum urinary flow rate ≥ 15 ml/sec
• Transrectal ultrasound determined prostate volume \> 60cc
• AUA symptom score \< 9
• Active urinary tract infection
• Bleeding diathesis
• Neurological disease that is felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder
• Known prostate cancer
• Active bladder cancer (within the last 2 years)
• Prostate specific antigen (PSA) \> 4.0 unless previous negative biopsy
• Urinary retention
• Post-void residual (PVR) \> 300 cc

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead
• Lumenis Be Ltd.: collaborator

Study Sites (3)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Oakwood Annapolis Hospital

Westland, Michigan, 48186, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• James E Lingeman, MD

  Methodist Urology, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 25, 2008

Record last verified: 2008-04

Locations

US (3)