Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better". In case of reintervention, the patient will complete a PGI-I-Reintervention (same questionnaire as PGI-I) at 6 months after surgical reintervention.

The description of identified Restorelle mesh Device Deficiencies and categorized according to the association or not with Adverse Device Effect (ADE) or Serious ADE

Post-operative pain will be reported and evaluated by the patient using the modified TOMUS/PREM questionnaire through:

• Location and Intensity VAS
• Pain duration: acute or chronic (more than 6 months)
• Treatment: types, drug name (if medication) and duration
• Persistent pain, beyond 2 weeks, will be defined as having

1. pain intensity ≥ 40 (VAS) at any of locations (lower abdomen, vagina, lower back and back of legs/buttocks) or during any activity or
2. pain medication use.

The changes in the Pelvic Floor Disability Index (PFDI-20 questionnaire) total score and sub scores.

Pelvic Floor Distress Inventory (PDFI-20) is comprised of 3 subscales for a total of 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 (with higher scores indicating more distress/dysfunction). The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.

The number of patients rating "yes" at "vaginal bulge" determined by the PFDI-20/POPDI-6 and requiring additional treatment for POP since index procedure

The percentage of patients rating "yes" at "vaginal bulge" determined by the PFDI-20/POPDI-6 and requiring additional treatment for POP since index procedure

The changes in QoL total score using EQ-5D-5L and their evolution. The General Health Outcome Status questionnaire (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions which are divided into 5 levels of perceived problems: from level 1 indicating no problem to level 5 indicating extreme problems. The patient indicates her health state in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, from 'The best health you can imagine' to 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgment.

The changes in QoL total score using the Pelvic Floor Impact Questionnaire (PFIQ-7) and their evolution.

Pelvic Floor Impact Questionnaire (PFIQ-7) consists of 7 questions. The responses for each question range from "not at all" (0) to "quite a bit" (3). To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA revised (PISQ-IR): is composed of 20 items including the scales for arousal \& orgasm, partner related, condition specific, global quality, condition impact and desire. The number of cases for each scale that can be scored. The mean and standard deviation are provided for each scale.

Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better".

Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better".

Surgical Satisfaction Questionnaire (SSQ-8): is a validated questionnaire used to measure patient satisfaction following a surgery to correct prolapse and/or incontinence. Answers of the SSQ questions consisted of a 5-point scale ranging from "very satisfied" to "very unsatisfied" or from "yes" to "never". Patients' satisfaction is defined if answers correspond with "very satisfied" and "satisfied" or "yes" and "may be".

Surgical Satisfaction Questionnaire (SSQ-8): is a validated questionnaire used to measure patient satisfaction following a surgery to correct prolapse and/or incontinence. Answers of the SSQ questions consisted of a 5-point scale ranging from "very satisfied" to "very unsatisfied" or from "yes" to "never". Patients' satisfaction is defined if answers correspond with "very satisfied" and "satisfied" or "yes" and "may be".