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Phase 2/Phase 3
40 Years
70 Years
Open (Enrolling by invite only)
Female
Female, Bladder Cancer, Radical Cystectomy, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

residual urine Change after operation

Outcome Time Frame:

3,6,12,18,24month after operation

Safety Issue:

Yes

Principal Investigator

ZhiWen Chen, Master

Investigator Role:

Study Chair

Investigator Affiliation:

Urology Institute of Southwest Hospital, Chongqin, China

Authority:

China: Ministry of Health

Study ID:

Neobladder-01

NCT ID:

NCT01273987

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Female
  • Bladder Cancer
  • Radical Cystectomy
  • Neobladder
  • Posterior Wall Suspended With Round Ligament of Uterus
  • Urinary Bladder Neoplasms

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