Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

NCT ID: NCT01073241

Last Updated: 2010-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-02-29

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

transurethral prostatic resection

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

Group Type: ACTIVE_COMPARATOR

transurethral prostatic resection

Intervention Type: PROCEDURE

The patients' prostate was resected with the conventional Nesbit TURP

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.

Group Type: EXPERIMENTAL

transurethral ventral wall of urethra-preserving enucleation of prostate

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

transurethral prostatic resection

The patients' prostate was resected with the conventional Nesbit TURP

Intervention Type: PROCEDURE

Other Intervention Names

TUEP; TURP

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Urology Department of Southwest Hospital, China

Principal Investigators

Zhang Jiahua

Role: STUDY_DIRECTOR

Urology Institute of Southwest Hospital, Chongqin, China

Locations

Department of Urology, Southwest Hospital

Shapinba, Chongqin, China

Countries

China

Other Identifiers

SouthwestH

Identifier Type: -

Identifier Source: org_study_id