Comparison of ambulatory versus conventional urodynamics in assessing the function of neobladder in patients underwent radical cystectomy and orthotopic urine substitution.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000040561
• Date of registration: 20/01/2015
• Prospective Registration: No
• Primary sponsor: Gennimatas General Hospital of Thessaloniki
• 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.
• Date of first enrolment: 02/06/2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000040561.aspx
• Study type: Observational
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Dr Kampantais Spyridon

• Name: Dr Kampantais Spyridon

Key inclusion & exclusion criteria

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
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


Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Bladder

Bladder Cancer;
Bladder Cancer

Intervention(s)

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.

Primary Outcome(s)

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.[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).
]

To compare pressure of the neobladder wall ("detrusor pressure")between the conventional and ambulatory urodynamics[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(s)

To estimate and compare the post void residual urine volume recorded on ambulatory and conventional UDS[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). ]

To estimate and compare the mean voided volume recorded on ambulatory and conventional UDS on the voiding phase of the study[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 ID(s)

Nil