Objective of this study is to map the possible differences in immunostatus between a urethra in patients with a Hautmann neobladder and a normal urethra in patients without (a history of urogenital) malignancy; to find clues for the decreased risk…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the immunostatus of the urethra.
Secondary outcome
not applicable
Background summary
In bladdercancer recurrence is a major problem. These recurrences can be
located in the upper urinary tract, the urethra, local or at distant sites.
Multiple factors are associated with recurrence in the urethra. One of these
factors is the type of bladderdiversion; the risk of urethral recurrence after
Hautmann neobladder is decreased compared to the non-orthotopic
bladderdiversions. No explanation is known for this difference.
The most successful treatment of non-muscle invasive bladder cancer is
aspecific immunotherapy with BCG bladder instillations. Although the exact mode
of action remains to be solved, an infectious reaction of the bladder wall
plays a crucial role in the effect of BCG. Likewise, we hypothesized that the
chronic low grade infection in an ileal neobladder might protect the urethra
against recurrent UCC. Therefore, infection parameters in urethral biopsies
might shed light on this theory.
Study objective
Objective of this study is to map the possible differences in immunostatus
between a urethra in patients with a Hautmann neobladder and a normal urethra
in patients without (a history of urogenital) malignancy; to find clues for the
decreased risk of urethral recurrence in patients with a Hautmann neobladder.
Study design
Explorable, single centre study (Radboud University Nijmegen Medical Center)
In 10 patients with a Hautmann neobladder we'll take two supervicial urethral
biopsies during a cystoscopy (part of routine oncological follw-up) on the
outpatient department.
In 10 patients two supervicial urethral biopsies are taken during the
transurethral surgery for which they are plannend.
Study burden and risks
Risks: bleeding from the biopsy leasion and urethral pain.
PO Box 9101
6500 HB Nijmegen
Nederland
PO Box 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
group 1:
- patients who underwent a cystectomy + Hautmann neobladder for bladder cancer
- since at least 1 year ago
- patients must be over 18 years of age;group 2:
- patiënts who are plannend for TURP, bladder neck incision or urethrotomy (no malignancy).
- patients must be over 18 years of age
Exclusion criteria
group 1:
- patients who underwent cystectomy with a type of urinary diversion other than Hautmann neobladder.
- use of anticoagulant drugs;group 2:
- history of urological malignancy
- use of anticoagulant drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22226.091.08 |