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Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Primary Purpose

Benign Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transurethral ventral wall of urethra-preserving enucleation of prostate
transurethral prostatic resection
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Department of Urology, Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

transurethral prostatic resection

ventral wall of urethra-preserving enucleation of prostate

Arm Description

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

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

Outcomes

Primary Outcome Measures

urodynamic study

Secondary Outcome Measures

Full Information

First Posted
February 22, 2010
Last Updated
March 12, 2010
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01073241
Brief Title
Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
Official Title
Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transurethral prostatic resection
Arm Type
Active Comparator
Arm Description
The patients' prostate was resected with the conventional Nesbit TURP.
Arm Title
ventral wall of urethra-preserving enucleation of prostate
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
transurethral ventral wall of urethra-preserving enucleation of prostate
Other Intervention Name(s)
TUEP
Intervention Description
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
Intervention Name(s)
transurethral prostatic resection
Other Intervention Name(s)
TURP
Intervention Description
The patients' prostate was resected with the conventional Nesbit TURP
Primary Outcome Measure Information:
Title
urodynamic study
Time Frame
before operation and the third month, 6th month after operation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Jiahua
Organizational Affiliation
Urology Institute of Southwest Hospital, Chongqin, China
Official's Role
Study Director
Facility Information:
Facility Name
Department of Urology, Southwest Hospital
City
Shapinba
State/Province
Chongqin
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

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Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

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