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

NCT05836844 | Recruiting FDA Device

• 1 other identifier: IDIL/2022/RdT01 2023-A00289-36
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Prolapse; Female; Prolapse Uterovaginal; Prolapse; Cervix

Keywords

pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• Successful performance after sacrospinous fixation of the Anchorsure System®.

  YES /NO

  12 months after fixation

Secondary Outcomes (31)

• Device or procedure-related adverse events: Daily Pain score

  Day 0 to Day 30

• Device or procedure-related adverse events: Anchor palpability

  36 months after surgery

• Device or procedure-related adverse events: Abnormal findings on clinical examination

  36 months after surgery

• Type of sacrospinous fixation technique used

  Day 0

• Success of the intervention

  36 months after surgery

Interventions

The Anchorsure System® DEVICE

Sacrospinous ligament fixation performed with the Anchorsure Device

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Must have biological female reproductive organs.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• University Hospital, Lille: collaborator
• Kremlin-Bicetre Hospital, Paris: collaborator
• Clinique Sainte-Anne, Strasbourg: collaborator
• Centre Hospitalier de La Rochelle: collaborator

Study Sites (4)

La Rochelle General Hospital

La Rochelle, 17000, France

RECRUITING

Lille University Hospital

Lille, 59000, France

RECRUITING

Kremlin-Bicêtre Hospital

Paris, 94270, France

RECRUITING

Clinique Sainte-Anne

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Renaud de TAYRAC, Professor

CONTACT

+334 66 68 32 16; renaud.detayrac@chu-nimes.fr

Anissa MEGZARI

CONTACT

+334 66 68 42 36; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: May 11, 2023
• Primary Completion: October 1, 2024
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (4)