Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169767
Status:
TERMINATED
Last Update Posted:
2008-04-25
First Post:
2005-09-09
Brief Title:
Holmium Laser Ablation of the Prostate HoLAP Versus KTP Laser Vaporization of the Prostate
Sponsor:
Indiana Kidney Stone Institute
Organization:
Indiana Kidney Stone Institute
Study Overview
Official Title:
Holmium Laser Ablation of the Prostate HoLAP Versus KTP Laser Vaporization of the Prostate A Randomized Comparison Study
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The traditional surgical therapy for BPH is a transurethral resection of the prostate McConnell et al 1994 This surgery involves the insertion of a telescope resectoscope transurethrally into the prostate and bladder An electrocautery loop attached to the resectoscope is then used to core out the inside of the prostate until the surgical capsule of the prostate is reached A large catheter is left in the bladder for at least 1 day and saline irrigation of the bladder is often required for post-operative bleeding Once the urine is clear the catheter is removed and the patient undergoes a voiding trial If voiding is successful the patient is discharged home
TURP produces excellent short and long-term results and remains a standard of care for the surgical treatment of BPH Unfortunately this durable procedure has many potential risks and complications including bleeding requiring blood transfusion 5 intraoperative complications eg prostate capsule perforation urethral and bladder injury dilutional hyponatremia and the TUR syndrome urinary tract infection 5-10 incontinence 1 erectile dysfunction 5 bladder neck contracture or urethral stricture 5 and delayed bleeding resulting in clot retention or secondary procedures to control bleeding American Urological Association AUA Guideline on Management of Benign Hyperplasia 2003 Chapter 1 Diagnosis and Treatment Recommendations Journal of Urology 170 530 2003
One alternative to TURP that has been shown in a randomized clinical trial to reproduce the excellent results of TURP has been holmium laser ablation of the prostate HoLAP Mottet et al 1999 HoLAP is a simple procedure to perform in smaller prostate glands ideally 60 gm and recently reported results suggest that this procedure produces good results that are durable up to 7 years Gilling et al 2002
A new technology for use during prostate ablation is the high power potassium titanyl-phosphate KTP laser Malek et al 2000 This surgical procedure involves the use of the Laserscope KTP laser San Jose CA to vaporize obstructing prostatic tissue in a technique similar to HoLAP Most investigators have reported no significant complications with this new technology and in most cases significant improvements in American Urological Association symptom scores and urine flow rates have been documented Malek et al 2000 Unfortunately no randomized comparison study between HoLAP and KTP laser prostatectomy has been performed
TURP produces excellent short and long-term results and remains a standard of care for the surgical treatment of BPH Unfortunately this durable procedure has many potential risks and complications including bleeding requiring blood transfusion 5 intraoperative complications eg prostate capsule perforation urethral and bladder injury dilutional hyponatremia and the TUR syndrome urinary tract infection 5-10 incontinence 1 erectile dysfunction 5 bladder neck contracture or urethral stricture 5 and delayed bleeding resulting in clot retention or secondary procedures to control bleeding American Urological Association AUA Guideline on Management of Benign Hyperplasia 2003 Chapter 1 Diagnosis and Treatment Recommendations Journal of Urology 170 530 2003
One alternative to TURP that has been shown in a randomized clinical trial to reproduce the excellent results of TURP has been holmium laser ablation of the prostate HoLAP Mottet et al 1999 HoLAP is a simple procedure to perform in smaller prostate glands ideally 60 gm and recently reported results suggest that this procedure produces good results that are durable up to 7 years Gilling et al 2002
A new technology for use during prostate ablation is the high power potassium titanyl-phosphate KTP laser Malek et al 2000 This surgical procedure involves the use of the Laserscope KTP laser San Jose CA to vaporize obstructing prostatic tissue in a technique similar to HoLAP Most investigators have reported no significant complications with this new technology and in most cases significant improvements in American Urological Association symptom scores and urine flow rates have been documented Malek et al 2000 Unfortunately no randomized comparison study between HoLAP and KTP laser prostatectomy has been performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None