Evaluation of the Anchorsure® Device for Treating Apical Prolapse in Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study evaluates the performance and safety of the Anchorsure® transvaginal device in women undergoing surgical treatment for apical prolapse. The study focuses on patients with pelvic organ prolapse who are scheduled for sacrospinous fixation using the Anchorsure® system. Participants will be followed for 36 months to assess the effectiveness of the device in reducing operative time and postoperative pain while ensuring strong fixation. The primary objective is to determine the device's performance one year after surgery in real-life settings.

Why it matters

Who can join: the full rules

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

Where it's running

• La Rochelle General Hospital
  La Rochelle, France Recruiting
• Lille University Hospital
  Lille, France Recruiting
• Kremlin-Bicêtre Hospital
  Paris, France Recruiting
• Clinique Sainte-Anne
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Renaud de TAYRAC, Professor
• Email: renaud.detayrac@chu-nimes.fr
• Phone: +334 66 68 32 16

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.