Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.
Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical compartment including recurrence.
Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence.
All women who have not indicated any objection to participating in the study.
All women who have been correctly informed.
Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry).
Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®.
Patients with uncontrolled diabetes mellitus.
Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis.
The target population is the population of adult women, undergoing a surgical treatment of The target population is the population of adult women, undergoing a surgical treatment for pelvic organ prolapse using Anchorsure System® in the participating centres: Nîmes University Hospital, Lille University Hospital, Sainte-Anne Clinic in Strasbourg, La Rochelle Hospital and Kremlin-Bicêtre Hospital.
Cohort
Prospective
The Anchorsure System®
DeviceSacrospinous ligament fixation performed with the Anchorsure Device
Successful performance after sacrospinous fixation of the Anchorsure System®.
YES /NO
Device or procedure-related adverse events: Daily Pain score
All procedure-related adverse events and complications will be recorded using the Clavien-Dindo classification system with a one-month pain diary (filled in once a day using a visual analog scale of 0 to 10 for buttock pain;
Device or procedure-related adverse events: Anchor palpability
The anchor palpability score will be recorded regularly for up to 36 months after surgery.
Device or procedure-related adverse events: Abnormal findings on clinical examination
All abnormal findings on clinical examination will be reported including suture exposure, anchor extrusion into another organ, perforation, organ or vascular or nerve injury/damage, fistula, bleeding including hematoma (requiring transfusion or not), thrombotic event, neuromuscular problems (including pain), pelvic discomfort or pain, de novo dyspareunia, infection (e.g. vaginal, urinary tract infection), urinary tract complications including ureteric disorders, urinary retention requiring drainage \> 48h, urge symptoms or incontinence (worsening or de novo), de novo constipation or faecal incontinence. Incidences of adverse events will be determined overall, by type of adverse event, severity, compartment and type of sacrospinous suspension (uni versus bilateral and anterior versus posterior).
Type of sacrospinous fixation technique used
The type of sacrospinous fixation technique used: uni/bilateral, anterior/posterior will be recorded
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Centre Hospitalier Universitaire de Nīmes
Lead sponsor
University Hospital, Lille
Collaborator
Kremlin-Bicetre Hospital, Paris
Collaborator
Clinique Sainte-Anne, Strasbourg
Collaborator
Centre Hospitalier de La Rochelle
Collaborator
