Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273987
• Other study ID #: Neobladder-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2020
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 20, 2020
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Urology Institute of PLA, Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiwen Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postvoiding residual urine (PVP)	number of patients with postvoiding residual urine (PVP) more than 100ml	2 years after operation
Primary	clean intermittent catheterization(CIC)	number of patients required clean intermittent catheterization(CIC)	2 years after operation
Secondary	rate of complication	number of patients with any complication	through study completion, an average of 2 years
Secondary	urodynamic profile	urodynamic parameter including peak flow rate, functional urethral length ...etc	12 months afer operation
Secondary	rate of continence of neobladder	number of patients with continence at daytime and nighttime	12 months after operation