Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
1 other identifier
interventional
80
1 country
1
Brief Summary
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 4, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedJuly 11, 2012
July 1, 2012
2.5 years
July 4, 2012
July 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
Secondary Outcomes (6)
Operation time
resected adenoma weight as a measure of treatment efficacy
changes in serum haemoglobin as a measure of one of the complications
postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
5 years
postoperative Qmax as a masure of treatment efficacy and durability
5 years
- +1 more secondary outcomes
Study Arms (2)
PkEP
ACTIVE COMPARATORPatients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
B-TURP
ACTIVE COMPARATORPatients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
Interventions
Eligibility Criteria
You may qualify if:
- Qmax \< 10 mL/s, IPSS \>19
- Age between 50 and 70 years
- Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
You may not qualify if:
- Patients with neurogenic bladder
- Urethral stricture
- Bladder tumor
- Prostate cancer and previous prostate bladder neck
- Urethral surgery
- PSA\>4ng/ml, or receiving prostate biopsy within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuzhou General Hospital
Fuzhou, Fujian, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jianming Tan, M.D. & Ph.D.
Fuzhou General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2012
First Posted
July 11, 2012
Study Start
June 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2011
Last Updated
July 11, 2012
Record last verified: 2012-07