Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

Official title

APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.

Overview

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.

Detailed description

Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most frequent. Treatment options for women with apical prolapse range from observation, non-surgical treatment or surgical repair. The use of an anchoring device reduces dissection and operative time and is supposed to provide a strong fixation while minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages have to be evaluated in terms of performance and safety. This is a cohort study on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.The primary objective of the study is to evaluate the performance of the Anchorsure System® for sacrospinous suspension 12 months after surgical treatment of women with apical prolapse in real-life settings.

Interventions

• Device The Anchorsure System®
  Sacrospinous ligament fixation performed with the Anchorsure Device

Primary outcome measures

• Successful performance after sacrospinous fixation of the Anchorsure System®. [Time frame: 12 months after fixation]

Secondary outcome measures (12)

• Device or procedure-related adverse events: Daily Pain score [Time frame: Day 0 to Day 30]
• Device or procedure-related adverse events: Anchor palpability [Time frame: 36 months after surgery]
• Device or procedure-related adverse events: Abnormal findings on clinical examination [Time frame: 36 months after surgery]
• Type of sacrospinous fixation technique used [Time frame: Day 0]
• Success of the intervention [Time frame: 36 months after surgery]
• Complications/adverse events [Time frame: 36 months after surgery]
• Severity of adverse events [Time frame: 36 months after surgery]
• Compartments treated [Time frame: 36 months after surgery]
• Potential risk factors for the success/failure of the treatment at baseline: Age [Time frame: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Body Mass Index [Time frame: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Previous history of pelvic surgery [Time frame: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Chronic constipation [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …).
• Patients with a history of radiotherapy in the pelvic area.
• Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month.
• patients under ongoing oral anticoagulant therapy.
• Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery
• Patients with a preoperative infection contraindicating the surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

France · 4 centers

• La Rochelle General Hospital — La Rochelle
• Lille University Hospital — Lille
• Kremlin-Bicêtre Hospital — Paris
• Clinique Sainte-Anne — Strasbourg

Identifiers

NCT: NCT05836844 · IDIL/2022/RdT01 2023-A00289-36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗