1. To asses non-inferiority of BSC mesh in surgical success (= anatomic cure, subjective improvement and no re-treatment necessary) in the treatment of apical prolapse compared to unilateral SSLF at 12 months;2. Improvement of quality of life…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Surgical success (= anatomic cure, subjective improvement and no
re-treatment necessary) in the treatment of apical prolapse compared to
unilateral SSLF at 12 months;
2. Improvement of quality of life related to pelvic floor function at 12 months
after surgery (PFDI-20).
Secondary objectives
Secondary outcome
1. Morbidity (Pain, ADL, hospital stay, surgical parameters, postoperative
recovery, blood loss);
2. Quality of life score (PFDI-20): improvement stratified by compartment;
3. Sexual satisfaction (PISQ-12) improvement from baseline
4. To asses superiority of BSC mesh in surgical success (anatomic cure,
subjective improvement and no re-treatment necessary) in the treatment of
apical prolapse compared to unilateral SSLF at 12 months when non-inferiority
has been proven;
5. Procedure related serious adverse events.
Background summary
Pelvic organ prolapse (POP) is a condition in which pelvic organs descend into
the vagina, resulting in problems with micturition (i.e. urinary incontinence
or incomplete voiding), defecation (i.e. constipation or fecal incontinence) or
sexual functioning (i.e. dyspareunia). *** POP is very common with an estimated
prevalence of 30%. ***If the patient is bothered by symptoms, surgery is
proposed which is usually performed vaginally. At the moment long term results
of POP surgery are far from optimal with reported recurrence rates up to 40%.
One out of three POP operations is performed for recurrent prolapse, and some
patients even undergo numerous operations. ***
Unilateral Sacrospinous Ligament Fixation (SSLF) is the recommended treatment
option for patients suffering from apical POP. In unilateral SSLF, the top of
the vagina is sutured to the sacrospinous ligament. Unilateral SSLF has an
objective cure rate of 85-90% and has a relatively low recurrence rate.
Complications in SSLF are rare; A review of 22 studies that in total included
1229 patients reported severe bleeding in just three patients (0.2%). ***
However, because of the direct fixation to the sacrospinous ligament,
unilateral SSLF could result in an anatomical alteration of the vagina and the
rectum in which there will be a posterior deviation which can have consequences
on voiding, defecation and sexual function.
Bilateral fixation as compared to unilateral fixation is - as a result of the
distal fixation of sutures - supposed to be more effective, because there is no
posterior deviation of the vagina. Bilateral fixation using non-absorbable
sutures has shown optimal anatomical results (94.3% objective and 93%
subjective cure) and improved quality of life after surgery. ***
Bilateral Sacrospinous Colposuspension (BSC) using synthetic mesh, however,
could even result in an anatomy that is similar to the original nulliparous
anatomy. A better anatomical repair could be associated with a positive effect
on sexual outcome, voiding and defecation.
Also, using mesh for a posterior sacral fixation of the vaginal top has shown a
lower risk of recurrence.
Study objective
1. To asses non-inferiority of BSC mesh in surgical success (= anatomic cure,
subjective improvement and no re-treatment necessary) in the treatment of
apical prolapse compared to unilateral SSLF at 12 months;
2. Improvement of quality of life related to pelvic floor function at 12 months
after surgery (PFDI-20).
Study design
A multicentre non-inferiority randomized-controlled trial to compare unilateral
sacrospinous ligament fixation with bilateral sacrospinous colposuspension
using polypropylene macropore mesh. Follow up of 12 months.
Intervention
nvt
Study burden and risks
Baseline: physical examination ( POP Q) and 3 questionnaires
The first week patients will keep a diary about experienced discomfort.
6 weeks after surgery: physical examination and 3 questionnaires
6 months after surgery: 2 guestionnairs
12 months after surgery: physical examination and 4 questionnaires
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Subject is female;
2. Subject is least 18 years of age;
3. Subject has at least a stage 2 apical prolapse and is planned to undergo vaginal surgical correction.
Exclusion criteria
1. Subjects who are pregnant or want to become pregnant;
2. Subjects who are not capable of giving informed consent;
3. Subject has a known sensitivity to polypropylene;
4. Subject has an indication for a concomitant procedure to treat SUI;
5. Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical);
6. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis;
7. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit).
Design
Recruitment
Medical products/devices used
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 | NL60451.018.17 |