Primary objective: to determine the degree of spongiofibrosis and the actual stricture length based on MRU compared to X-RUG and intra-operative findings.Secondary objectives: to determine the clinical value of a new MR protocol in the evaluation of…
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the correlation stricture length and the degree of
spongiofibrosis based on MRU compared to X-RUG and intra-operative findings.
Secondary outcome
- The amount of patients in which the initial treatment plan, based on
retrograde urethrography only, changes after MRU.
- Difference in degree of invasiveness between X-RUG and MRU.
Background summary
Retrograde urethrography (X-RUG) is currently the gold standard imaging
technique in the evaluation of urethral strictures. In contrast to X-RUG,
Magnetic Resonance Urethrography (MRU) is less invasive, seems to be able to
give additional information about the periurethral tissue pathology and can
give an accurate estimation of stricture length. These characteristics are of
crucial importance for selection of treatment. Current literature about the
role of MRU is promising but still limited. Moreover, previous studies
performed the MR urethrography technique filling the urethra in retrograde
phase and injected de urethra with sterile gel. We think this technique can
easily provide overestimation of stricture length and patient discomfort. At
the moment the general view is that more studies are needed, with different new
MR protocols, before MRU will become the new gold standard.
Study objective
Primary objective: to determine the degree of spongiofibrosis and the actual
stricture length based on MRU compared to X-RUG and intra-operative findings.
Secondary objectives: to determine the clinical value of a new MR protocol in
the evaluation of urethral strictures.
Study design
Single centre, prospective, observational study.
Study burden and risks
Subjects will undergo MRU in addition to the standard X-RUG. MRU is minimally
invasive as subjects will not be exposed to X-radiation or receive contrast
agents. Small risk of urinary tract infection by X-RUG is not to be expected in
MRU. All subjects have to sign informed consent and fill in the inclusion
criteria list for MRU based on inclusion and exclusion criteria as listed in
chapter 4, section 4.2 and 4.3.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Clinical suspicion of urethral stricture disease.
- Initial diagnostic imaging technique is X-RUG.
- Age > 18 years.
- Gender: male.
- Written informed consent.
Exclusion criteria
- Electronically, magnetically and/or mechanically implants;
- Cardiac pacemakers;
- Metallic splinters in the eye;
- Ferromagnetic hemostatic clips in the central nervous system;
- Cochlear implant;
- Insulin pumps and/or nerve stimulators;
- Leas wire or similar wires;
- Prosthetic heart valves;
- Hemostatic clips (body);
- Non-ferromagnetic stapedial implants;
- Claustrophobia.
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 | NL63278.078.17 |