Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

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.

Study Overview

• Status: Unknown
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: transurethral prostatic resection; Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqin
    • Shapinba, Chongqin, China, 400038
      • Department of Urology, Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transurethral prostatic resection; The patients' prostate was resected with the conventional Nesbit TURP.	Procedure: transurethral prostatic resection; The patients' prostate was resected with the conventional Nesbit TURP; Other Names: TURP
Experimental: 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.	Procedure: 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.; Other Names: TUEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
urodynamic study	before operation and the third month, 6th month after operation

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Study Director: Zhang Jiahua, Urology Institute of Southwest Hospital, Chongqin, China

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 15, 2010
• Last Update Submitted That Met QC Criteria: March 12, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: benign prostatic hyperplasia; Transurethral Resection of Prostate; transurethral enucleation of prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: SouthwestH (Other Identifier: SouthwestH)