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

Comparison of ambulatory versus conventional urodynamics of modified orthotopic Hautmann neobladder in patients with bladder cancer who underwent radical cystectomy and orthotopic urine substitution.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000040561

Enrollment

Registered

2015-01-20

Start date

2014-06-02

Completion date

2014-12-19

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Healthy volunteers

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

Outcome results