To evelauate the clinical efficacy after 12 months using a composite outcome: absence of apical prolapse (st 0 or I), absence of bulge symptoms, and absence of reintervention in the treated vaginal compartments (apical and anterior)
ID
Source
Brief title
Condition
- Other condition
- Uterine, pelvic and broad ligament disorders
Synonym
Health condition
prolaps behandeling met toekomstig oog op vermindering van recidieven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
see above: composite outcome
Secondary outcome
quality of life and bother scores and sexual function, measured with PFDI-20,
PFIQ-7 and PISQ-12.
Background summary
Prolpapse repair using native tissue knows high recurrence rates. Mesh
reinforced repairs reduce anatomic recurrence rates. Apical support is of
crucial importance in prolapse repair surgery. Uphold Lite Mesh is CE marked
and in use.
Study objective
To evelauate the clinical efficacy after 12 months using a composite outcome:
absence of apical prolapse (st 0 or I), absence of bulge symptoms, and absence
of reintervention in the treated vaginal compartments (apical and anterior)
Study design
prospective observational cohort, european multicenter
Study burden and risks
as in routine vaginal prolapse repair surgeries
Place du Professeur Debre 30029
Nimes, France 30029 Cedex 09
FR
Place du Professeur Debre 30029
Nimes, France 30029 Cedex 09
FR
Listed location countries
Age
Inclusion criteria
stage II or greater uterine and anterior vaginal wall prolapse
Exclusion criteria
under age 50
Design
Recruitment
metc-ldd@lumc.nl
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 |
|---|---|
| Other | 2011-A01705-36 |
| CCMO | NL41643.098.12 |