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 -a Prospective Control Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273987

Enrollment

Registered

2011-01-11

Start date

2011-01-01

Completion date

2020-03-20

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Female, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus, Radical Cystectomy

Brief 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

Detailed 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.

Interventions

PROCEDURErONB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
postvoiding residual urine (PVP)	2 years after operation	number of patients with postvoiding residual urine (PVP) more than 100ml
clean intermittent catheterization(CIC)	2 years after operation	number of patients required clean intermittent catheterization(CIC)

Secondary

Measure	Time frame	Description
rate of complication	through study completion, an average of 2 years	number of patients with any complication
urodynamic profile	12 months afer operation	urodynamic parameter including peak flow rate, functional urethral length ...etc
rate of continence of neobladder	12 months after operation	number of patients with continence at daytime and nighttime

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026