NCT01273987

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

8.9 years

First QC Date

January 7, 2011

Last Update Submit

March 27, 2020

Conditions

FemaleBladder CancerRadical CystectomyNeobladderPosterior Wall Suspended With Round Ligament of Uterus

Outcome Measures

Primary Outcomes (2)

  • postvoiding residual urine (PVP)

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

    2 years after operation

  • clean intermittent catheterization(CIC)

    number of patients required clean intermittent catheterization(CIC)

    2 years after operation

Secondary Outcomes (3)

  • rate of complication

    through study completion, an average of 2 years

  • urodynamic profile

    12 months afer operation

  • rate of continence of neobladder

    12 months after operation

Study Arms (2)

neobladder with round lig

EXPERIMENTAL

ileal neobladder suspened with round ligament

Procedure: rONB

standard neobladder

NO INTERVENTION

conventional standard neobladder

Interventions

rONBPROCEDURE

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

neobladder with round lig

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Institute of PLA, Southwest Hospital

Chongqing, 400038, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • ZhiWen Chen, M.D.

    Urology Institute of PLA, Southwest Hospital, Chongqin, China

    STUDY CHAIR

  • HuiXiang Ji, M.D.

    Urology Institute of PLA, Southwest Hospital, Chongqin, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice director of urological institiute of PLA

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 11, 2011

Study Start

January 1, 2011

Primary Completion

November 8, 2019

Study Completion

March 20, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

CN(1)