Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Calistar A Calistar A mesh to treat anterior and apical POP |
Device: Calistar A mesh to treat anterior and apical POP
Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses
|
Calistar S Calistar S mesh to treat anterior and apical POP |
Device: Calistar S mesh to treat anterior and apical POP
Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
|
Outcome Measures
Primary Outcome Measures
- Percentage of Cured Participants According to Barber Criteria [Post-operative at 6 months]
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.
Secondary Outcome Measures
- Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) [Pre-operative and post-operative at 6 months]
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.
- Quality of Life Status: Patient Global Impression Questionnaire [Post-operative at 6 months]
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.
- Adverse Events [Intra-operative and post-operative at 6 months]
Register of adverse events. Clavien-Dindo classification
Other Outcome Measures
- Quality of Life: PFDI 20 [Post-operative at 6 months]
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).
- Quality of Life: PISQ-12 [Post-operative at 6 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Británico | Buenos Aires | Argentina | C1280AEB |
Sponsors and Collaborators
- Agustin Sampietro
Investigators
- Principal Investigator: Agustín Sampietro, Dr, Faculty of Medicine, University of Buenos Aires
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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.
- de Tayrac R, Madelenat P. [Evolution of surgical routes in female stress urinary incontinence]. Gynecol Obstet Fertil. 2004 Dec;32(12):1031-8. Review. French.
- 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.
- CaSCaA
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 91 | 126 |
COMPLETED | 91 | 126 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Calistar A | Calistar S | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 | Total of all reporting groups |
Overall Participants | 91 | 126 | 217 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
62
(9)
|
62
(8)
|
62
(8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
91
100%
|
126
100%
|
217
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (Count of Participants) | |||
Argentina |
32
35.2%
|
71
56.3%
|
103
47.5%
|
Brazil |
23
25.3%
|
19
15.1%
|
42
19.4%
|
Italy |
29
31.9%
|
30
23.8%
|
59
27.2%
|
France |
7
7.7%
|
6
4.8%
|
13
6%
|
Outcome Measures
Title | Percentage of Cured Participants According to Barber Criteria |
---|---|
Description | 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. |
Time Frame | Post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 91 | 126 |
Number [percentage of cured patients] |
82.42
|
90.48
|
Title | Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) |
---|---|
Description | 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. |
Time Frame | Pre-operative and post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 91 | 126 |
Number [percentage of cured patients] |
82.42
|
88.88
|
Title | Quality of Life Status: Patient Global Impression Questionnaire |
---|---|
Description | 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. |
Time Frame | Post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 91 | 126 |
Median (Full Range) [units on a scale] |
5
|
5
|
Title | Adverse Events |
---|---|
Description | Register of adverse events. Clavien-Dindo classification |
Time Frame | Intra-operative and post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Adverse events were presented in a separate section. |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 0 | 0 |
Title | Quality of Life: PFDI 20 |
---|---|
Description | 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). |
Time Frame | Post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 91 | 126 |
Median (Full Range) [score on a scale] |
30.85
|
19.4
|
Title | Quality of Life: PISQ-12 |
---|---|
Description | 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. |
Time Frame | Post-operative at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Calistar A | Calistar S |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 91 | 126 |
Median (Full Range) [score on a scale] |
0
|
0
|
Adverse Events
Time Frame | 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 | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Calistar A | Calistar S | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Calistar A | Calistar S | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/91 (0%) | 0/126 (0%) | ||
Serious Adverse Events |
||||
Calistar A | Calistar S | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/91 (0%) | 0/126 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Calistar A | Calistar S | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 30/91 (33%) | 14/126 (11.1%) | ||
Renal and urinary disorders | ||||
Urinary tract infection | 12/91 (13.2%) | 12 | 1/126 (0.8%) | 1 |
Surgical and medical procedures | ||||
Pain | 6/91 (6.6%) | 6 | 6/126 (4.8%) | 6 |
Reoperation for prolapse | 2/91 (2.2%) | 2 | 2/126 (1.6%) | 2 |
Mesh erosion | 10/91 (11%) | 10 | 5/126 (4%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Agustín Sampietro |
---|---|
Organization | Universidad de Buenos Aires |
Phone | +5491158336327 |
asampietro@live.com.ar |
- CaSCaA