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Trial registered on ANZCTR


Registration number
ACTRN12615000040561
Ethics application status
Approved
Date submitted
30/11/2014
Date registered
20/01/2015
Date last updated
20/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of ambulatory versus conventional urodynamics in assessing the function of neobladder in patients underwent radical cystectomy and orthotopic urine substitution.
Scientific title
Comparison of ambulatory versus conventional urodynamics of modified orthotopic Hautmann neobladder in patients with bladder cancer who underwent radical cystectomy and orthotopic urine substitution.
Secondary ID [1] 285756 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 293643 0
Condition category
Condition code
Cancer 293939 293939 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Conventional and ambulatory urodynamic assessment (pressure - flow studies) in patients who underwent radical cystectomy for bladder cancer and orthotopic Hautmann W - neobladder with Abol Enein - Ghoneim uretero-intestinal anastomosis.
At the beginning of the study, patients are undergone conventional UDS using the Solar Silver (registered trademark) urodynamic device (MMS). The filling rate generally follow the formula weight in kg divided by four in ml/min but this is adjusted accordingly. All patients are in sitting position during the conventional UDS and the duration of conventional UDS is approximately 60 minutes.
Ambulatory UDS is performed subsequently at a date different from that of conventional UDS. On average the duration is approximately 18 hours. This orthograde filling cystometry is performed using the Luna (Wireless- Bluetooth) device with microtip catheters (MMS). Proper placement of the intravesical catheter is checked with the use of ultrasonography.
Each participant undertakes both assessments at baseline only.
Intervention code [1] 290719 0
Not applicable
Comparator / control treatment
Conventional urodynamic assessment is the comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293715 0
To compare intravesical pressure of the neobladder between the conventional and ambulatory urodynamics.
Intravesical pressure is automatically assessed by the machines with microtip catheters placed into patients' bladder.
Timepoint [1] 293715 0
The estimation of conventional UDS is going to be done at least one year after the procedure. Ambulatory UDS will be performed subsequently at a date different from that of conventional (10-15 days after conventional UDS).
Primary outcome [2] 293716 0
To compare pressure of the neobladder wall ("detrusor pressure")between the conventional and ambulatory urodynamics
Timepoint [2] 293716 0
The estimation of conventional UDS is going to be done at least one year after the procedure. Ambulatory UDS will be performed subsequently at a date different from that of conventional (10-15 days after conventional UDS).
Secondary outcome [1] 311650 0
To estimate and compare the mean voided volume recorded on ambulatory and conventional UDS on the voiding phase of the study
Timepoint [1] 311650 0
The estimation of conventional UDS is going to be done at least one year after the procedure. Ambulatory UDS will be performed subsequently at a date different from that of conventional (10-15 days after conventional UDS).
Secondary outcome [2] 311651 0
To estimate and compare the post void residual urine volume recorded on ambulatory and conventional UDS
Timepoint [2] 311651 0
The estimation of conventional UDS is going to be done at least one year after the procedure. Ambulatory UDS will be performed subsequently at a date different from that of conventional (10-15 days after conventional UDS).

Eligibility
Key inclusion criteria
1. Patients with bladder urolthelial cell carcinoma (UCC) who underwent radical cystectomy and orthotopic Hautmann W - neobladder with Abol Enein - Ghoneim uretero-intestinal anastomosis for
2. at least one year before the initiation of the study
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active Radiotherapy
Active Chemotherapy
Urethral stricture
Postoperative hernia
Chronic renal failure (estimated GFR < 60 mL/min/1.73 m2
Active urinary tract infection (UTI)
Hospitalized for other reasons
Continuous urinary incontinence
Deny to participate

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6500 0
Greece
State/province [1] 6500 0

Funding & Sponsors
Funding source category [1] 290325 0
Self funded/Unfunded
Name [1] 290325 0
Address [1] 290325 0
Country [1] 290325 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 289044 0
None
Name [1] 289044 0
Address [1] 289044 0
Country [1] 289044 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
During the last decades, orthotopic reconstruction, following radical cystectomy for bladder cancer, is increasingly used. To date, different segments of intestine and different techniques have been used, aiming to succeed a sufficient functional reservoir capacity and to reduce intravesical pressure for the protection of upper urinary tract. In order to record this neobladder function, conventional urodynamic studies (UDS) has been used. However, this method is being accused that it is not able to mimic the patients’ symptoms, as they are in real life. In contrast, ambulatory UDS, that uses natural bladder filling, is thought to elicit more representative results.
According to our knowledge, there is no information in the literature for the comparison of these two methods in patients with orthotopic neobladder substitution after radical cystectomy. For this reason, a record and a comparison of orthograde and retrograde filling cystometry findings was conducted in patients who had undergone modified orthotopic Hautmann neobladder following bladder removal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53142 0
Dr Malioris Apostolis
Address 53142 0
Malioris Apostolis
A’ Urologic department of Aristotle University of Thessaloniki, Greece
41 Ethnikis Aminis, Thessaloniki, 54643
Country 53142 0
Greece
Phone 53142 0
+30 6974350579
Fax 53142 0
Email 53142 0
ap.malioris@gmail.com
Contact person for public queries
Name 53143 0
Dr Kampantais Spyridon
Address 53143 0
Kampantais Spyridon
A’ Urologic department of Aristotle University of Thessaloniki, Greece
41 Ethnikis Aminis, Thessaloniki, 54643
Country 53143 0
Greece
Phone 53143 0
+30 6945375525
Fax 53143 0
Email 53143 0
kabspir@hotmail.com
Contact person for scientific queries
Name 53144 0
Dr Kampantais Spyridon
Address 53144 0
Kampantais Spyridon
A’ Urologic department of Aristotle University of Thessaloniki, Greece
41 Ethnikis Aminis, Thessaloniki, 54643
Country 53144 0
Greece
Phone 53144 0
+30 6945375525
Fax 53144 0
Email 53144 0
kabspir@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary