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Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Southwest Hospital, China.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01073241
First received: February 22, 2010
Last updated: March 12, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Benign Prostatic Hyperplasia
 Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate
Procedure: transurethral prostatic resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • urodynamic study [ Time Frame: before operation and the third month, 6th month after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TUEP

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.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073241

Locations
China, Chongqin
Department of Urology, Southwest Hospital
Shapinba, Chongqin, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Study Director: Zhang Jiahua Urology Institute of Southwest Hospital, Chongqin, China
  More Information

No publications provided

Responsible Party: JiHuixiang, Urology Department of Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01073241     History of Changes
Other Study ID Numbers: SouthwestH
Study First Received: February 22, 2010
Last Updated: March 12, 2010
Health Authority: China: Ministry of Health

Keywords provided by Southwest Hospital, China:
benign prostatic hyperplasia
Transurethral Resection of Prostate
transurethral enucleation of prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013