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Completed

NCT Number: NCT01637701

Plasmakinetic Enucleation of the Prostate to Treat 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.

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Key information

Conditions

BPH With Large Prostate Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fuzhou General Hospital

Fuzhou, Fujian, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PkEP

Procedure

Plasmakinetic enucleation of the prostate

B-TURP

Procedure

Bipolar transurethral resection of the prostate

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

  1. Operation time

  2. resected adenoma weight as a measure of treatment efficacy

  3. changes in serum haemoglobin as a measure of one of the complications

  4. postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability

    Time frame: 5 years

  5. postoperative Qmax as a masure of treatment efficacy and durability

    Time frame: 5 years

  6. re-operation rate as a measure of durability

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2011
First posted
Jul 11, 2012
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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