see Background
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be disease specific quality of life, as measured with
the urogenital distress inventory (UDI).
Secondary outcome
Secondary outcomes will be women*s perceived improvement in the prolapse
symptoms, clinicians grading of prolapse at one year of follow-up.
Background summary
Objective: Pelvic organ prolapse is a common condition in women. Almost 50% of
the women will deal with this problem during lifetime. Vaginal vault prolapse
can be treated with two completely different strategies; i.e. pessary use or
prolapse surgery. Both strategies are efficacious treatments, with each having
their own advantages and disadvantages. However, studies directly comparing
both treatments are lacking. We therefore designed a randomised clinical trial
on the subject. In this trial, we look at the disease specific quality of life
after randomisation between pessary use and prolapse surgery. We also compare
general quality of life, anatomic results, cost-effectiveness and the
contributiveness to therapy.
Study objective
see Background
Study design
Randomised Controlled Trial.
Study burden and risks
Questionairres of 30 minutes (4 times). One extra visit to the hospital with an
gynaecology examination.
de run 4600
5500 VB Veldhoven
Nederland
de run 4600
5500 VB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Vaginal prolapse stage 2-4 (POP-Q criteria, ICS).
Exclusion criteria
Prolapse surgery of incontinence surgery in the history
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 | NL24091.015.08 |