To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh + Monocryl (Prolift+MTM) with the standard vaginal prolapse surgery (i.e. fascial placation). A secondary objective is to track the post-operative and long-term…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the percentage of patients with objective anatomical
success (POP stage <2) after 24 months.
Secondary outcome
As secondary outcome the subjective improvement in quality of life will be
measured by generic (EQ-5D) and disease-specific (UDI, DDI, IIQ and PFDI20)
quality of life instrument. Sexual functioning will be measured by generic
(FSFI) and disease specific (PISQ12) questionnaires. Complications will be
monitored with special notice for pain (Mc Gill pain questionnaire) Recovery
will be measured with the Recovery index 10. The economical endpoint is short
term (2 year) incremental cost-effectiveness in terms of costs per additional
year free of prolapse and costs per QALY gained.
Background summary
Pelvic organ prolapse is highly prevalent in the female population. The
incidence of pelvic organ prolapse increases with age, so the longer life
expectancy of women may cause pelvic organ prolapse to become an even more
major health issue. The recurrence rate of pelvic organ prolapse after surgical
treatment is high. The recurrence rate of the anterior vaginal wall prolapse
after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall prolapse
recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the
clinical need for improvement of the surgical techniques currently used.
Placement of a mesh aims at reducing the recurrence rate (2-11%).
Study objective
To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh
+ Monocryl (Prolift+MTM) with the standard vaginal prolapse surgery (i.e.
fascial placation). A secondary objective is to track the post-operative and
long-term complications of both procedures. A third objective is to evaluate
recovery after surgery
Study design
This study is a prospective, multicentre, randomized, non-blinded study between
Tension free Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal
prolapse surgery (i.e. fascial plication).
Intervention
Prolapse surgery with tension free vaginal mesh + Monocryl (Prolift + M) versus
conventional vaginal prolapse surgery.
Study burden and risks
Burden associated with participation: complete a disease specific Quality of
life questionnaire 4 times, complete a recovery index questionnaire 3 times.
Visit the hospital 4 times after the surgery (this is 2 times more often than
patients not participating in the study)
Since subjects are selected from subjects already agreeing to complete a
surgical procedure, the additional risks of participation in this study are
low.
These risks include tissue erosion (vaginal, rectal or bladder), vaginal
pain/dyspareunia.
Geert Grooteplein-Zuid 14
6525 GA Nijmegen
NL
Geert Grooteplein-Zuid 14
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
primary pelvic organ prolapse (anterior and/or posterior compartment) POP stage II or more
age >44 years
Exclusion criteria
pregnancy
age < 45 years
previous prolapse surgery
blood coagulation disorders
a compromised immune system or any other conditions that would compromise healing
unwilling or unable to return for evaluation
Previous irradiation
Presence of any malignancy
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 |
|---|---|
| Other | dit protocol wordt binnenkort geregistreerd in clinicaltrials.gov |
| CCMO | NL31706.091.10 |