Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

NCT01073241 | Unknown

• 1 other identifier: SouthwestH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia; Transurethral Resection of Prostate; transurethral enucleation of prostate

Outcome Measures

Primary Outcomes (1)

• urodynamic study

  before operation and the third month, 6th month after operation

Study Arms (2)

transurethral prostatic resection

ACTIVE COMPARATOR

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

Procedure: transurethral prostatic resection

ventral wall of urethra-preserving enucleation of prostate

EXPERIMENTAL

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

Interventions

transurethral ventral wall of urethra-preserving enucleation of prostate PROCEDURE

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

Also known as: TUEP

ventral wall of urethra-preserving enucleation of prostate

transurethral prostatic resection PROCEDURE

The patients' prostate was resected with the conventional Nesbit TURP

Also known as: TURP

transurethral prostatic resection

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Department of Urology, Southwest Hospital

Shapinba, Chongqin, 400038, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhang Jiahua

  Urology Institute of Southwest Hospital, Chongqin, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 15, 2010

Record last verified: 2010-02

Locations

CN (1)