Status:
TERMINATED
Holmium Laser Ablation of the Prostate (HoLAP) Versus KTP Laser Vaporization of the Prostate
Lead Sponsor:
Indiana Kidney Stone Institute
Collaborating Sponsors:
Lumenis Be Ltd.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
18+ years
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 a...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00169767
Start Date
May 1 2005
End Date
April 1 2008
Last Update
April 25 2008
Active Locations (3)
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1
Methodist Hospital
Indianapolis, Indiana, United States, 46202
2
Oakwood Annapolis Hospital
Westland, Michigan, United States, 48186
3
Duke University
Durham, North Carolina, United States, 27710