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Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer —a Prospective Control Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01273987
First received: January 7, 2011
Last updated: January 10, 2011
Last verified: December 2010
History of Changes
  Purpose

Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder


Condition Intervention Phase
Female
Bladder Cancer
Radical Cystectomy
Neobladder
Posterior Wall Suspended With Round Ligament of Uterus
 Procedure: Neobladder posterior wall suspended with round ligament of uterus
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • residual urine Change after operation [ Time Frame: 3,6,12,18,24month after operation ] [ Designated as safety issue: Yes ]
  • score of life quality Change after operation [ Time Frame: 3,6,12,18,24 month after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • information about operation [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ]
    hemorrhage; blood transfusion; persistence time of operation; Length of Stay after operation

  • urodynamic parameter Change after operation [ Time Frame: 3,6,12,18,24 month afer operation ] [ Designated as safety issue: Yes ]
  • urine control Change after operation [ Time Frame: 3,6,12,18,24 month after operation ] [ Designated as safety issue: Yes ]
    urine controll at daytime;urine controll at nighttime


Estimated Enrollment: 70
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard neobladder Procedure: Neobladder posterior wall suspended with round ligament of uterus
Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria for the study were bladder cancer (Stage T1G3, T2-3N0-NxM0), female (age between 40 and 70 years old), no history of urethral trauma or urethral stricture; and a desire to obtain an orthotopic neobladder

Exclusion Criteria:

  • The exclusion criteria were male sex, posterior urethral margin confirmed as cancer invasive by pathology; and enteritis. The indications and contraindications for orthotopic reconstruction in this study conformed to the criteria set by the guidelines of the European Association of Urology on bladder cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273987

Locations
China, ChongQin
Urology Institute of Southwest Hospital
Shapinba, ChongQin, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Study Chair: ZhiWen Chen, Master Urology Institute of Southwest Hospital, Chongqin, China
Principal Investigator: HuiXiang Ji, Doctor Urology Institute of Southwest Hospital, Chongqin, China
  More Information

No publications provided

Responsible Party: Zhiwen Chen, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01273987     History of Changes
Other Study ID Numbers: Neobladder-01
Study First Received: January 7, 2011
Last Updated: January 10, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013