OBJECTIVE: through MRI research, we want to map the pelvic floor structures that are involved in holding a pessary in place
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Surface of the hiatus
Pubococcygeal line, length cervix, transvaginal length, diameter and defect
musculus levator ani
Secondary outcome
Possible secondary outcomes are: pubococcygeale line, cervix length ,
transvaginal length , diameter and defect musculuis levator ani in relation to
a standard pessary. The final secondary outcomes, we can not determine yet. The
final secondary outcomes will be explored during the analysis of the MRI images
.
Background summary
BACKGROUND: More than 50 percent of the women above 40 years, deal with a
prolapse of the bladder, uterus, rectum or a combination. Not all women
experience symptoms of their prolapse. For the women who experience symptoms of
their prolapse, there are several treatment options. They can choose pelvic
physiotherapy, pessary therapy or surgical treatment. 57% of the women with
symptoms of their prolapse choose pessary therapy. After 3 years, almost 50
percent of these women quited the pessary therapy. Furthermore, there is also a
group of women, where it is not possible to find a suitable pessary. For this
reason they are forced to switch to surgical treatment. For optimization of
pessary therapy, it is important to have an insight in the pelvic floor
structures that are involved in holding a pessary in place. The pelvic anatomy
is extremely complex and there are differences in anatomy reported in the
current literature and anatomy books. Meanwhile, by improving techniques it is
possible to picture the pelvic anatomy better. We will hope to get an answer to
the question why it is impossible to find a suited pessary for all women.
Study objective
OBJECTIVE: through MRI research, we want to map the pelvic floor structures
that are involved in holding a pessary in place
Study design
STUDY DESIGN: Pilot study
Study burden and risks
The risk for women to participate consists of one extra visit to perform an
MRI. An MRI shows no radiation exposure or health risk to the participating
women. Women with severe contraindications to MRI such as pacemaker , severe
claustrophobia , etc. are excluded. The personal benefit of women to
participate in this study is the financial compensation consists of a coupon of
25 euro and refund of travel expenses.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Women with an anterior vaginal wall prolaps and/or prolapse of the cervix minimal POP-Q stage II, who are minimal one year treated with pessarytherapy and have no more prolapse complaints and where the pessary shows a good corrections of the prolapse.
- Woman with an anterior vaginal wall prolaps and/or prolapse of the cervix minimal POP-Q stage II, who choose pessarytherapie, but it is not possible to find a pessary that show a good correction of the prolapse and give no more prolapse complaints.
Exclusion criteria
- Age of 18 years or more
- Patients who are mentally incompetent
- Patients with a posterior vaginal wall prolaps as leading part and where the posterior vaginal wall prolaps the indication is for therapy
- Patients with former prolapse surgery
- Contra-indications for MRI
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 | NL51656.068.15 |