Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems

Study Overview
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Brief Summary
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The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).

Detailed Description
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The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.

Official Title
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Calistar A vs. Calistar S - Cohort Retrospective Analysis

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Calistar A mesh to treat anterior and apical POP
* Device: Calistar S mesh to treat anterior and apical POP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI) Primary or recurrent treatment with Calistar S or Calistar A At least 6 months follow-up Exclusion Criteria: Recurrent vaginal infections, Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis). Presence of any coagulopathies, Impairment of the immune system or any condition that compromises recovery, Prior irradiation Chronic pelvic pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Calistar A<br>Calistar A mesh to treat anterior and apical POP | Device: Calistar A mesh to treat anterior and apical POP<br>* Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses<br>|
| Calistar S<br>Calistar S mesh to treat anterior and apical POP | Device: Calistar S mesh to treat anterior and apical POP<br>* Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cured Participants According to Barber Criteria | According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure. | Post-operative at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) | Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1. | Pre-operative and post-operative at 6 months | 
| Quality of Life Status: Patient Global Impression Questionnaire | Patient satisfaction with the experience and the result of procedure will be evaluated with the Patient Global Impression questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome. | Post-operative at 6 months | 
| Adverse Events | Register of adverse events. Clavien-Dindo classification | Intra-operative and post-operative at 6 months |