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Completed

NCT Number: NCT01273987

Neobladder Posterior Wall Suspended With Round Ligament of Uterus

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

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Key information

Conditions

Female Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neobladder Neoplasms Neoplasms by Site Posterior Wall Suspended With Round Ligament of Uterus Radical Cystectomy Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Urology Institute of PLA, Southwest Hospital

Chongqing, 400038, China

About this study

The investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. In this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rONB

Procedure

Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer

Primary outcomes

  1. postvoiding residual urine (PVP)

    Time frame: 2 years after operation

    number of patients with postvoiding residual urine (PVP) more than 100ml

  2. clean intermittent catheterization(CIC)

    Time frame: 2 years after operation

    number of patients required clean intermittent catheterization(CIC)

Secondary outcomes

  1. rate of complication

    Time frame: through study completion, an average of 2 years

    number of patients with any complication

  2. urodynamic profile

    Time frame: 12 months afer operation

    urodynamic parameter including peak flow rate, functional urethral length ...etc

  3. rate of continence of neobladder

    Time frame: 12 months after operation

    number of patients with continence at daytime and nighttime

Sponsors and collaborators

Lead sponsor

Zhiwen Chen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Jan 11, 2011
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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