Clinical trial NCT05836844: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prolapse; Female
Prolapse Uterovaginal
Prolapse; Cervix
Keywords: pelvic organ prolapse
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Kremlin-Bicetre Hospital, Paris
name: Clinique Sainte-Anne, Strasbourg
name: Centre Hospitalier de La Rochelle
First posted: 2023-05-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Successful performance after sacrospinous fixation of the Anchorsure System®.
timeFrame: 12 months after fixation
Secondary outcomes:
measure: Device or procedure-related adverse events: Daily Pain score
timeFrame: Day 0 to Day 30
measure: Device or procedure-related adverse events: Anchor palpability
timeFrame: 36 months after surgery
measure: Device or procedure-related adverse events: Abnormal findings on clinical examination
timeFrame: 36 months after surgery
measure: Type of sacrospinous fixation technique used
timeFrame: Day 0
measure: Success of the intervention
timeFrame: 36 months after surgery
measure: Complications/adverse events
timeFrame: 36 months after surgery
measure: Severity of adverse events
timeFrame: 36 months after surgery
measure: Compartments treated
timeFrame: 36 months after surgery
measure: Potential risk factors for the success/failure of the treatment at baseline: Age
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Body Mass Index
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Previous history of pelvic surgery
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Chronic constipation
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Chronic pulmonary conditions
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Vaginal compartment
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Type of prolapse
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Pelvic organ Prolapse Q grade
timeFrame: Day 0
measure: Potential risk factors for the success/failure of the treatment at baseline: Concomitant surgery
timeFrame: Day 0
measure: Potential risk factors for the occurrence of complications: Age
timeFrame: Day 0
measure: Potential risk factors for the occurrence of complications: Body Mass Index
timeFrame: Day 0
measure: Potential risk factors for the occurrence of complications: Smoking.
timeFrame: Day 0
measure: Potential risk factors for the occurrence of complications: Sexual intercourse.
timeFrame: Day 0
measure: Potential risk factors for the occurrence of complications: concomitant surgery
timeFrame: Day 0
measure: Evolution of the PFDI-20 quality of life score
timeFrame: Day 0
measure: Evolution of the PFDI-20 quality of life score
timeFrame: Up to 36 months after surgery.
measure: Evolution of quality of life scores : PFIQ-7
timeFrame: Day 0
measure: Evolution of quality of life scores : PFIQ-7
timeFrame: Up to 36 months after surgery.
measure: Evolution of quality of life scores : PISQ-IR
timeFrame: Day 0
measure: Evolution of quality of life scores : PISQ-IR
timeFrame: Up to 36 months after surgery.
measure: Patient satisfaction
timeFrame: Up to 36 months after surgery.
measure: Global impression of improvement (PGI-I)
timeFrame: Up to 36 months after surgery
measure: Frequency of revision and/or surgical re-intervention
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: La Rochelle General Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Paris
country: France
facility: Kremlin-Bicêtre Hospital
city: Strasbourg
country: France
facility: Clinique Sainte-Anne
Study officials:
References: