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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status: Completed

Conditions: BPH With Large Prostate

Treatments: Procedure: B-TURP; Procedure: PkEP

Study type: Interventional

Funder types: Other

Identifiers

NCT01637701

PkEP-TURP-2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

PkEP

Active Comparator group

Description:

Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).

Treatment:

Procedure: PkEP

B-TURP

Active Comparator group

Description:

Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).

Treatment:

Procedure: B-TURP