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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
History of Changes
  Purpose

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.


Condition Intervention
BPH With Large Prostate
 Procedure: PkEP
Procedure: B-TURP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: June 2004
Study Completion Date: December 2011
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PkEP
Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
 Procedure: PkEP
Plasmakinetic enucleation of the prostate
Active Comparator: B-TURP
Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
 Procedure: B-TURP
Bipolar transurethral resection of the prostate

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637701

Locations
China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Study Director: Jianming Tan, M.D. & Ph.D. Fuzhou General Hospital
  More Information

No publications provided

Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01637701     History of Changes
Other Study ID Numbers: PkEP-TURP-2004
Study First Received: July 4, 2012
Last Updated: July 7, 2012
Health Authority: China: Ministry of Health

Keywords provided by Fuzhou General Hospital:
benign prostatic hypertrophy
bipolar transurethral resection of the prostate
plasmakinetic enucleation of the prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013