Pelvic Organ Prolapse
Conditions
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).
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.
Interventions
DEVICECalistar A mesh to treat anterior and apical POP
Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses
DEVICECalistar S mesh to treat anterior and apical POP
Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Sponsors
Agustin Sampietro
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 91 |
| 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 | 126 |
| Total | 217 |
Baseline characteristics
| Characteristic | Calistar S | Total | Calistar A |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Argentina | 71 Participants | 103 Participants | 32 Participants |
| Region of Enrollment Brazil | 19 Participants | 42 Participants | 23 Participants |
| Region of Enrollment France | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment Italy | 30 Participants | 59 Participants | 29 Participants |
| Sex: Female, Male Female | 126 Participants | 217 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 126 |
| other Total, other adverse events | 30 / 91 | 14 / 126 |
| serious Total, serious adverse events | 0 / 91 | 0 / 126 |
Outcome results
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.
Time frame: Post-operative at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calistar A | Percentage of Cured Participants According to Barber Criteria | 82.42 percentage of cured patients |
| Calistar S | Percentage of Cured Participants According to Barber Criteria | 90.48 percentage of cured patients |
Secondary
Adverse Events
Register of adverse events. Clavien-Dindo classification
Time frame: Intra-operative and post-operative at 6 months
Population: Adverse events were presented in a separate section.
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.
Time frame: Pre-operative and post-operative at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calistar A | Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) | 82.42 percentage of cured patients |
| Calistar S | Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) | 88.88 percentage of cured patients |
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.
Time frame: Post-operative at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Calistar A | Quality of Life Status: Patient Global Impression Questionnaire | 5 units on a scale |
| Calistar S | Quality of Life Status: Patient Global Impression Questionnaire | 5 units on a scale |
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).
Time frame: Post-operative at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Calistar A | Quality of Life: PFDI 20 | 30.85 score on a scale |
| Calistar S | Quality of Life: PFDI 20 | 19.4 score on a scale |
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.
Time frame: Post-operative at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Calistar A | Quality of Life: PISQ-12 | 0 score on a scale |
| Calistar S | Quality of Life: PISQ-12 | 0 score on a scale |