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

YES /NO

All procedure-related adverse events and complications will be recorded using the Clavien-Dindo classification system with a one-month pain diary (filled in once a day using a visual analog scale of 0 to 10 for buttock pain;

The anchor palpability score will be recorded regularly for up to 36 months after surgery.

All abnormal findings on clinical examination will be reported including suture exposure, anchor extrusion into another organ, perforation, organ or vascular or nerve injury/damage, fistula, bleeding including hematoma (requiring transfusion or not), thrombotic event, neuromuscular problems (including pain), pelvic discomfort or pain, de novo dyspareunia, infection (e.g. vaginal, urinary tract infection), urinary tract complications including ureteric disorders, urinary retention requiring drainage > 48h, urge symptoms or incontinence (worsening or de novo), de novo constipation or faecal incontinence. Incidences of adverse events will be determined overall, by type of adverse event, severity, compartment and type of sacrospinous suspension (uni versus bilateral and anterior versus posterior).

The type of sacrospinous fixation technique used: uni/bilateral, anterior/posterior will be recorded

Success is defined as per primary objective and assessed at 36 months after surgery; compartments treated: anterior, apical, posterior, total; type of prolapse: primary or recurrent prolapse.

Collection of all complications/adverse events up to 36 months after surgery.

Determination of the level of severity of the adverse event: mild, moderate, severe.

Compartments treated: anterior, apical, posterior, total; type of sacrospinous suspension: uni/bilateral, anterior/posterior.

Collection of potential risk factors for the success/failure of the treatment at baseline: The patient's age will be recorded

Collection of potential risk factors for the success/failure of the treatment at baseline: the patient's Body Mass Index will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of pelvic surgery will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of chronic constipation will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of chronic pulmonary conditions will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: Details of the patient's vaginal compartment will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: The type of prolapse (recurrent or primary) will be recorded.

Collection of potential risk factors for the success/failure of the treatment at baseline: the patient's Pelvic Organ Prolapse (POPQ) grade will be recorded as follows :

Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen Stage 2 the most distal portion of the prolapse is 1 cm or less proximal or distal to the hymenal plane Stage 3 the most distal portion of the prolapse protrudes more than 1 cm below the hymen but protrudes no farther than 2 cm less than the total vaginal length (for example., not all of the vagina has prolapsed) Stage 4 vaginal eversion is essentially complete

Collection of potential risk factors for the success/failure of the treatment at baseline: details of any concomitant surgery will be recorded.

The patient's age will be recorded in years

The patient's body mass index (BMI) will be calculated and recorded. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

The patient's smoking status will be recorded (Regular smoker/Weaned/Number of cigarettes per day/week).

The frequency of the patient's sexual intercourse will be recorded.

All details of any concomitant surgery in non-target compartment, other concomitant surgery i.e. hysterectomy, mid uretral sling for SUI, etc…will be recorded.

The Pelvic Floor Distress inventory (PFDI) includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.

The Pelvic Floor Distress inventory (PFDI) includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7), a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ), is a questionnaire about the social impact of the patient's pelvic floor disorders. It consistś of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7), a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ), is a questionnaire about the social impact of the patient's pelvic floor disorders. It consistś of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.

The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised by the International UroGynocological Association (PISQ-IR) is a disease-specific tool for evaluating the sexual function in women with pelvic floor disorders. It is useful in screening for sexual disorders in women with Urinary Incontinence (UI), pelvic organ prolapse (POP), and anal incontinence. It is used to assess the impact of pelvic floor disorders on female sexual activity and inactivity.

The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised by the International UroGynocological Association (PISQ-IR) is a disease-specific tool for evaluating the sexual function in women with pelvic floor disorders. It is useful in screening for sexual disorders in women with Urinary Incontinence (UI), pelvic organ prolapse (POP), and anal incontinence. It is used to assess the impact of pelvic floor disorders on female sexual activity and inactivity.

Patient satisfaction will be recorded on a Visual Analog Scale with scores ranging from 0= Extremely Dissatisfied to 6= Extremely Satisfied.

The Patient Global impression of improvement (PGI-I) is a scale to describes how the patient's post-operative condition is compared with how it was before surgery:

Very much better = 1, Much better = 2, A little better = 3, No change = 4, A little worse = 5, Much worse = 6, Very much worse = 7

The frequency of revision and/or surgical re-intervention including anti-incontinence surgery after sacrospinous suspension will be recorded