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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-12-30

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).

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Calistar A

Calistar A mesh to treat anterior and apical POP

Intervention Type DEVICE

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

Intervention Type DEVICE

Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses

Interventions

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Calistar A mesh to treat anterior and apical POP

Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses

Intervention Type DEVICE

Calistar S mesh to treat anterior and apical POP

Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No