Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Army Medical University

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: transurethral prostatic resection; Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT01073241

SouthwestH

Details and patient eligibility

About

In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.

Full description

Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination [maximum flow rate (QMax), detrusor pressure, and so on], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.

Enrollment: 200 estimated patients

Sex: Male

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BPH was diagnosed by DRE, Ultrasonography, CT or MR
• IPSS:>15
• Qmax:≤10ml/s and volume of bladder >200ml
• The weight of prostate >45g

Exclusion criteria

• Patient with other aggravating malignant tumor
• Total-PSA>20ng/ml, or 4<total-PSA<20ng/ml but the value of Free-PSA/total-PSA<0.16
• The maximum press of detrusor muscle <15cmH2O
• Patient with urethral stricture
• Patient with urinary infection
• Patient with Nervous System Disease
• Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

transurethral prostatic resection

Active Comparator group

Description:

The patients' prostate was resected with the conventional Nesbit TURP.

Treatment:

Procedure: transurethral prostatic resection

ventral wall of urethra-preserving enucleation of prostate

Experimental group

Description:

The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.

Treatment:

Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate