Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Not Applicable

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: transurethral prostatic resection; Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate

• Registration Number: NCT01073241
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Study Start: 2010-03
• Last Update Submitted: 2010-03-12
• Last Update Posted: 2010-03-15
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transurethral prostatic resection	transurethral prostatic resection	The patients' prostate was resected with the conventional Nesbit TURP.
ventral wall of urethra-preserving enucleation of prostate	transurethral ventral wall of urethra-preserving enucleation of prostate	The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.

Primary Outcome Measures

Name	Time	Method
urodynamic study	before operation and the third month, 6th month after operation

Trial Locations

Locations (1)

Department of Urology, Southwest Hospital; 🇨🇳 Shapinba, Chongqin, China