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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2028-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prolapse; Female Prolapse Uterovaginal Prolapse; Cervix

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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The Anchorsure System®

Sacrospinous ligament fixation performed with the Anchorsure Device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No