(Apical) pelvic organ prolapse, vaginal vault prolapse, uterine prolapse, pelvic floor descent Prolapse of the uterus or vagina
Conditions
Interventions
We compare posterior approach SSLF to anterior approach SSLF (both using the ANCORIS tissue achoring system). In both study groups, an additional anterior colporrhaphy is performed, as this is normal
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subject is female; Subject is least 18 years of age; Subject has at least a stage 2 apical prolapse and is planned to undergo vaginal surgical correction due to symptomatic (presence of vaginal bulge sensation) apical pelvic organ prolapse.Both surgical approaches are considered to be technically feasible by the operating surgeon, based on clinical and anatomical evaluation
Exclusion criteria
Exclusion criteria: Subjects who are pregnant or want to become pregnant; Subjects who are not capable of giving informed consent; Subject has a known sensitivity to polypropylene; Subject has an indication for a concomitant procedure to treat stress urinary incontinence (SUI); Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical); Subject previously had, currently has, or is planned to have pelvic radiation therapy Subject has an active or latent infection of the vagina, cervix or uterus Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis; 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be surgical “success” or “failure” assessed one year after surgery. The primary outcome measure has three components: anatomic success; leading edge of apical vaginal wall at or above the hymen using POP-Q examination the absence of vaginal bulge symptoms specific to prolapse, using two questions from the PFDI; no re-treatment necessary in the treatment (surgical or non-surgical) of apical prolapse repair. In both groups, an additional anterior colporrhaphy is added, as this is regular clinical practice. An additional perineoplasty may be added as well, if clinically indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare outcomes between anterior approach SSLF, and conventional posterior approach SSLF, at 6 weeks, 12 months, and 36 months using the following parameters: Morbidity (Pain, ADL, hospital stay, surgical parameters, postoperative recovery, blood loss); Quality of life: based on the Prolapse - Quality of Life (P-QoL) questionnaire, The Patient Global Impressions scale (PGI), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the Pelvic Floor Distress Inventory (PFDI-20) Estimated anatomical failure-free survival per Kaplan-Meier. Procedure related serious adverse events including complications at follow-ups, as well as their classification per Clavien-Dindo and IUGA/ICS terminology Prolapse occurrence in the non-target compartment Intraoperative characteristics (surgical duration, surgical complexity as perceived by the surgeon) | — |
Countries
Netherlands
Contacts
Public ContactJ.P.W.R. Roovers
Amsterdam UMC
Outcome results
None listed