To compare the effects of Elevate Posterior procedure versus sacrospinous ligament fixation on pelvic floor function.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life related to pelvic floor function measured using validated
disease-specific quality of life questionnaires (UDI, DDI, IIQ)
Secondary outcome
Sexual function at one year after intervention measured using the PISQ-12
questionnaire, POP-Q, morbidity (including post-operative pain, complications
and recovery of normal daily activities), generic quality of life, repeated
pelvic floor surgery within 12 months after intervention and cost analysis.
Background summary
Pelvic organ prolapse is a common health problem, with a life time risk to
undergo surgery of 11%. When dealing with an apical compartment prolapse the
most frequent proposed procedure is sacrospinous ligamant fixation, but
recently a mesh procedure (Elevate Posterior) was introduced. Although mesh is
not recommended as primary procedure based on objectified adverse effects like
exposure, pelvic pain and dyspareunia, there is theoretical basis to believe
that for apical prolapse, Elevate Posterior is beneficial compared to native
tissue repair. We propose a multi-center RCT comparing sacropinous ligament
fixation to Elevate Posterior in primary apical compartment prolapse.
Study objective
To compare the effects of Elevate Posterior procedure versus sacrospinous
ligament fixation on pelvic floor function.
Study design
A multi-center, randomised, controlled trial
Intervention
Elevate Posterior or sacrospinous ligament fixation
Study burden and risks
As we compare two strategies that are already applied in current clinical
practice, no additional risks from both procedures are expected. Evaluation
will take place after 6 weeks (routine post-operative consultation), by
telephone after 6 months and patients will be invited for one extra visit to
the hospital at 12 months (in some hospitals also a routine post-operative
consultation).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Sexually active women with a primary apical compartment prolapse stage * 2 requiring surgery.
Exclusion criteria
- Previous prolapse surgery
- Enterocele stage * 2 after hysterectomy (performed for other reasons than prolapse)
- Known malignancy
- Pregnancy or wish to become pregnant
- Unwilling to return for follow-up or language barriers
- Presence of immunological / haematological disorders interfering with recovery after surgery
- Abnormal ultrasound findings of uterus or ovaries.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38240.018.11 |
| OMON | NL-OMON27804 |