FemaleNCT01273987
Neobladder Posterior Wall Suspended With Round Ligament of Uterus
A study testing rONB in people with Female and Bladder Cancer, run by Zhiwen Chen at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Female, Bladder Cancer, Radical Cystectomy
- What is being tested?
- rONB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study
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
Read the 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.
- Conditions
- Female, Bladder Cancer, Radical Cystectomy, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus
- Being tested
- rONB
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rONBProcedure or surgery
Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
| Study group | Role | What they receive |
|---|---|---|
| neobladder with round lig | Experimental | ileal neobladder suspened with round ligament Receives: Procedure: rONB |
| standard neobladder | No intervention | conventional standard neobladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
postvoiding residual urine (PVP)
number of patients with postvoiding residual urine (PVP) more than 100ml
Measured: 2 years after operation
clean intermittent catheterization(CIC)
number of patients required clean intermittent catheterization(CIC)
Measured: 2 years after operation
Secondary outcomes (3)
rate of complication
number of patients with any complication
Measured: through study completion, an average of 2 years
urodynamic profile
urodynamic parameter including peak flow rate, functional urethral length ...etc
Measured: 12 months afer operation
rate of continence of neobladder
number of patients with continence at daytime and nighttime
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study start1 Jan 2011
- Primary completion8 Nov 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhiwen Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiwen Chen, Southwest Hospital, China
- Investigators
- ZhiWen Chen, M.D., Study chair, Urology Institute of PLA, Southwest Hospital, Chongqin, ChinaHuiXiang Ji, M.D., Principal investigator, Urology Institute of PLA, Southwest Hospital, Chongqin, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273987
- Sponsor's protocol ID
- Neobladder-01
- Status last verified
- Mar 2020
- First submitted
- 7 Jan 2011
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study
- ClinicalTrials.gov ID
- NCT01273987
- Acronym / sponsor ID
- Neobladder-01
- Conditions
- Female, Bladder Cancer, Radical Cystectomy, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Zhiwen ChenUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neobladder with round lig | Experimental | Procedure: rONBileal neobladder suspened with round ligament |
| standard neobladder | No intervention | –conventional standard neobladder |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rONBNeobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer | Procedure or surgery | neobladder with round lig |
Primary outcome
postvoiding residual urine (PVP)
Time frame: 2 years after operation
number of patients with postvoiding residual urine (PVP) more than 100ml
clean intermittent catheterization(CIC)
Time frame: 2 years after operation
number of patients required clean intermittent catheterization(CIC)
3 secondary outcomes
rate of complication
Time frame: through study completion, an average of 2 years
urodynamic profile
Time frame: 12 months afer operation
rate of continence of neobladder
Time frame: 12 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZhiWen Chen, M.D. study chair
Urology Institute of PLA, Southwest Hospital, Chongqin, China
HuiXiang Ji, M.D. principal investigator
Urology Institute of PLA, Southwest Hospital, Chongqin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rONB in people with Female and Bladder Cancer, run by Zhiwen Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postvoiding residual urine (PVP) (time frame: 2 years after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.