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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calistar A | Calistar A mesh to treat anterior and apical POP |
| |
| Calistar S | Calistar S mesh to treat anterior and apical POP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calistar A mesh to treat anterior and apical POP | Device | Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: PFDI 20 | Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress). | Post-operative at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Adults female
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| Name | Affiliation | Role |
|---|---|---|
| AgustÃn Sampietro, Dr | Faculty of Medicine, University of Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Británico | Buenos Aires | C1280AEB | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15589779 | Background | de Tayrac R, Madelenat P. [Evolution of surgical routes in female stress urinary incontinence]. Gynecol Obstet Fertil. 2004 Dec;32(12):1031-8. doi: 10.1016/j.gyobfe.2004.10.019. French. | |
| 26436858 | Background | Bigozzi MA, Provenzano S, Maeda F, Palma P, Riccetto C. In vivo biomechanical properties of heavy versus light weight monofilament polypropylene meshes. Does the knitting pattern matter? Neurourol Urodyn. 2017 Jan;36(1):73-79. doi: 10.1002/nau.22890. Epub 2015 Oct 5. |
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Only final clinical study report will be shared with the researchers participating in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Calistar A | Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses |
| FG001 | Calistar S | Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calistar A | Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses |
| BG001 | Calistar S |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of cured patients | Post-operative at 6 months |
|
All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calistar A | Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Surgical and medical procedures | Systematic Assessment |
Retrospective study; CaA procedures started a long time before the first CaS cases (Ca S level of surgeon training more experienced). Available data only enables mid-term follow-ups of differing duration's between the two groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. AgustÃn Sampietro | Universidad de Buenos Aires | +5491158336327 | asampietro@live.com.ar |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 28, 2018 | Mar 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2018 | Mar 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Calistar S mesh to treat anterior and apical POP | Device | Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses |
|
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 |
| Quality of Life: PISQ-12 | Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48. | Post-operative at 6 months |
| 19701041 | Background | Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae. |
| 22517068 | Background | Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, Swift S, Whitmore K, Ghoniem G, de Ridder D; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn. 2012 Apr;31(4):415-21. doi: 10.1002/nau.22238. |
| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. |
Calistar S mesh to treat anterior and apical POP
Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Number | percentage of cured patients | Pre-operative and post-operative at 6 months |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | units on a scale | Post-operative at 6 months |
|
|
|
| Secondary | Adverse Events | Register of adverse events. Clavien-Dindo classification | Adverse events were presented in a separate section. | Posted | Intra-operative and post-operative at 6 months |
|
|
| Other Pre-specified | Quality of Life: PFDI 20 | Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress). | Posted | Median | Full Range | score on a scale | Post-operative at 6 months |
|
|
|
| Other Pre-specified | Quality of Life: PISQ-12 | Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48. | Posted | Median | Full Range | score on a scale | Post-operative at 6 months |
|
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|
| 0 |
| 91 |
| 0 |
| 91 |
| 30 |
| 91 |
| EG001 | Calistar S | Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses | 0 | 126 | 0 | 126 | 14 | 126 |
| Reoperation for prolapse | Surgical and medical procedures | Non-systematic Assessment |
|
| Mesh erosion | Surgical and medical procedures | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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