Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT01637701
First received: July 4, 2012
Last updated: July 7, 2012
Last verified: July 2012

July 4, 2012
July 7, 2012
June 2004
December 2006   (final data collection date for primary outcome measure)
time of catheterization [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01637701 on ClinicalTrials.gov Archive Site
  • Operation time [ Designated as safety issue: Yes ]
  • resected adenoma weight as a measure of treatment efficacy [ Designated as safety issue: No ]
  • changes in serum haemoglobin as a measure of one of the complications [ Designated as safety issue: Yes ]
  • postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • postoperative Qmax as a masure of treatment efficacy and durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • re-operation rate as a measure of durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
BPH With Large Prostate
  • Procedure: PkEP
    Plasmakinetic enucleation of the prostate
  • Procedure: B-TURP
    Bipolar transurethral resection of the prostate
  • Active Comparator: PkEP
    Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
    Intervention: Procedure: PkEP
  • Active Comparator: B-TURP
    Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
    Intervention: Procedure: B-TURP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2011
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Male
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01637701
PkEP-TURP-2004
Yes
Fuzhou General Hospital
Fuzhou General Hospital
Not Provided
Study Director: Jianming Tan, M.D. & Ph.D. Fuzhou General Hospital
Fuzhou General Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP