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

BPH With Large Prostate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637701
• Other study ID #: PkEP-TURP-2004
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: July 7, 2012
• Start date: June 2004
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• BPH With Large Prostate
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Procedure:
• PkEP
Plasmakinetic enucleation of the prostate
• B-TURP
Bipolar transurethral resection of the prostate

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	Operation time			Yes
Secondary	resected adenoma weight as a measure of treatment efficacy			No
Secondary	changes in serum haemoglobin as a measure of one of the complications			Yes
Secondary	postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability		5 years	No
Secondary	postoperative Qmax as a masure of treatment efficacy and durability		5 years	No
Secondary	re-operation rate as a measure of durability		5 years	No